S-1 1 forms-1.htm

 

As filed with the Securities and Exchange Commission on July 6, 2021

 

Registration No. 333-               

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

 

BIOFRONTERA INC.

(Exact name of registrant as specified in its charter)

 

Delaware   2834   47-3765675

(State or other jurisdiction of

incorporation or organization)

 

(Primary Standard Industrial

Classification Code Number)

 

(I.R.S. Employer

Identification No.)

 

120 Presidential Way, Suite 330

Woburn, MA 01801

Telephone: 781-245-1325

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

 

Prof. Dr. Hermann Lübbert

Chief Executive Officer

Biofrontera Inc.

120 Presidential Way, Suite 330

Woburn, MA 01801

Telephone: 781-245-1325

(Name, address, including zip code, and telephone number, including area code, of agent for service)

 

Copies to:

 

Stephen E. Older, Esq.

Seth T. Goldsamt, Esq.

McGuireWoods LLP

1251 Avenue of the Americas

20th Floor

New York, NY 10020

Telephone: (212) 548-2100

Daniel Hakansson

Corporate Counsel

Biofrontera Inc.

120 Presidential Way, Suite 330

Woburn, MA 01801

Telephone: 781-486-1510

 

APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC: AS SOON AS PRACTICABLE AFTER THIS REGISTRATION STATEMENT IS DECLARED EFFECTIVE.

 

If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. [  ]

 

If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. [  ]

 

If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. [  ]

 

If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. [  ]

 

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 filer [  ]   Accelerated filer [  ]   Non-accelerated filer [X]   Smaller reporting company [X]   Emerging growth company [X]

 

If an emerging growth company, that prepares its financial statements in accordance with U.S. GAAP, 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 7(a)(2)(B) of the Securities Act. [  ]

 

CALCULATION OF REGISTRATION FEE

 

Title of Each Class of
Securities to be Registered
  Proposed
Maximum
Aggregate
Offering Price(1)
   Amount of
Registration Fee(2)
 
Common Stock, par value $0.001 value per share  $

25,000,000

   $

2,727.50

 

 

(1) Estimated solely for the purpose of calculating the amount of the registration fee in accordance with Rule 457(o) of the Securities Act of 1933, as amended. Included offering price of additional shares that the underwriters have the option to purchase to cover over-allotments.
(2)

Calculated pursuant to Rule 457(o) under the Securities Act based on an estimate of the proposed maximum offering price.

 

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

 

 

 

 
 

 

The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell nor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

 

Subject to Completion.

Dated         , 2021.

 

                              Shares

 

 

Common Stock

 

This is an initial public offering of shares of common stock of Biofrontera Inc.

 

We are offering                 shares of our common stock.

 

Immediately after this offering, assuming an offering size set forth above, Biofrontera AG, our parent company and sole existing stockholder, will own approximately       % of our outstanding shares of common stock. As a result, we expect to remain a “controlled company” within the meaning of the corporate governance standards of The Nasdaq Stock Market LLC (“Nasdaq”). See “Principal Stockholders.”

 

Prior to this offering, there has been no public market for our common stock. It is currently estimated that the initial public offering price per share of our common stock will be between $             and $             . We have applied to list our common stock on The Nasdaq Capital Market under the symbol “BFRI.”

 

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, and a “smaller reporting company”, as defined under applicable federal securities laws and, as such, we have elected to comply with certain reduced public company reporting requirements. See “Summary—Implications of Being an Emerging Growth Company and a Smaller Reporting Company.”

 

Investing in our common stock involves a high degree of risk. See “Risk Factors” beginning on page 8 to read about factors you should consider before buying shares of our common stock.

 

Neither the Securities and Exchange Commission nor any other regulatory body has approved or disapproved of these securities or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.

 

   Per Share   Total 
Initial public offering price  $   $ 
Underwriting discount(1)  $   $ 
Proceeds, before expenses, to Biofrontera Inc.  $   $ 

 

(1) See “Underwriting” for a description of the compensation payable to the underwriters.

 

To the extent that the underwriters sell more than            shares of our common stock, the underwriters have the option to purchase up to an additional            shares from us at the initial price to the public, less the underwriting discount, to cover over-allotments.

 

The underwriters expect to deliver the shares of our common stock against payment in New York, New York on                    , 2021.

 

The Benchmark Company

 

Prospectus dated                        , 2021.

 

 
 

 

TABLE OF CONTENTS

 

ABOUT THIS PROSPECTUS ii
BASIS OF PRESENTATION ii
TRADEMARKS ii
SUMMARY 1
RISK FACTORS 8
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS 42
USE OF PROCEEDS 43
CAPITALIZATION 44
DIVIDEND POLICY 45
DILUTION 46
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 47
BUSINESS 64
MANAGEMENT 88
EXECUTIVE COMPENSATION 93
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS 96
PRINCIPAL STOCKHOLDERS 98
DESCRIPTION OF CAPITAL STOCK 99
SHARES ELIGIBLE FOR FUTURE SALE 103
MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS 105
UNDERWRITING 109
LEGAL MATTERS 113
EXPERTS 113
WHERE YOU CAN FIND MORE INFORMATION 113
INDEX TO FINANCIAL STATEMENTS F-1

 

i
 

 

ABOUT THIS PROSPECTUS

 

We have not authorized anyone to provide any information or to make any representations other than those contained in this prospectus or in any related free writing prospectuses. We and the underwriters take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus is an offer to sell only the shares offered by this prospectus, but only under circumstances and in jurisdictions where it is lawful to do so. The information contained in this prospectus is current only as of its date. Our business, financial condition, results of operations and prospects may have changed since that date.

 

For investors outside the United States: We have not done anything that would permit this offering or the possession or distribution of this prospectus or any free writing prospectus we may provide to you in connection with this offering in any jurisdiction where action for purpose is required, other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the shares of our common stock and the distribution of this prospectus outside the United States. See “Underwriting.”

 

BASIS OF PRESENTATION

 

As used in this prospectus, unless the context otherwise requires, references to “we,” “us,” “our,” the “Company,” “Biofrontera” and similar references refer to Biofrontera Inc. References in this prospectus to the “Biofrontera Group” refer to Biofrontera AG and its consolidated subsidiaries, Biofrontera Pharma GmbH (individually, “Biofrontera Pharma”), Biofrontera Bioscience GmbH (individually “Biofrontera Bioscience”), Biofrontera Neuroscience GmbH (individually “Biofrontera Neuroscience”), and Biofrontera Development GmbH (individually “Biofrontera Development”). References in this prospectus to “Ferrer” refer to Ferrer Internacional S.A. References in this prospectus to Biofrontera’s “Licensors” refer collectively to Biofrontera Pharma, Biofrontera Bioscience and Ferrer. References in this prospectus to “Maruho” refer to Maruho Co., Ltd., and references to “Maruho Deutschland” refer to Maruho Deutschland GmbH, Maruho’s wholly owned subsidiary. References in this prospectus to “Cutanea” refer to Cutanea Life Sciences, Inc., which was acquired by Biofrontera in 2019 (“Cutanea acquisition”).

 

Our financial statements have been prepared in accordance with generally accepted accounting principles in the United States, or GAAP. Our fiscal year ends on December 31 of each year. References to fiscal 2019 and 2020 are references to the years ended December 31, 2019 and 2020. Our most recent fiscal year ended on December 31, 2020.

 

Certain monetary amounts, percentages and other figures included in this prospectus have been subject to rounding adjustments. Percentage amounts included in this prospectus have not in all cases been calculated on the basis of such rounded figures, but on the basis of such amounts prior to rounding. For this reason, percentage amounts in this prospectus may vary from those obtained by performing the same calculations using the figures in our financial statements included elsewhere in this prospectus. Certain other amounts that appear in this prospectus may not sum due to rounding.

 

TRADEMARKS

 

We have rights to trademarks and trade names that we use in connection with the operation of our business, including our corporate name, logos, product names and website names. Trademarks and trade names appearing in this prospectus are the property of their respective owners. Solely for your convenience, some of the trademarks and trade names referred to in this annual report are listed without the ® and TM symbols, but we will assert, to the fullest extent under applicable law, our rights, or the rights of the applicable licensor, to such trademarks and trade names.

 

ii
 

 

SUMMARY

 

This summary highlights selected information contained elsewhere in this prospectus. This summary does not contain all of the information that you should consider before deciding to invest in our common stock. You should read the entire prospectus carefully, including the “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and the related notes included elsewhere in this prospectus, before making an investment decision. Some of the statements in this prospectus constitute forward-looking statements. See “Special Note Regarding Forward-Looking Statements.”

 

Overview

 

We are a U.S.-based biopharmaceutical company specializing in the commercialization 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 licensed products focus on the treatment of actinic keratoses, which are skin lesions that can sometimes lead to skin cancer. We also market a topical antibiotic for treatment of impetigo, a bacterial skin infection.

 

Our principal product is Ameluz®, which is a prescription drug approved for use in combination with our licensor’s medical device, which has been approved by the U.S. Food and Drug Administration (the “FDA”), the BF-RhodoLED® lamp, for photodynamic therapy, or PDT, (when used together, “Ameluz® PDT”) in the United States for the lesion-directed and field-directed treatment of actinic keratosis of mild-to-moderate severity on the face and scalp. We are currently selling Ameluz® for this indication in the U.S. under an exclusive amended and restated license and supply agreement, or Ameluz LSA, by and among us, Biofrontera Pharma GmbH and Biofrontera Bioscience GmbH dated as of June 16, 2021. See “BusinessCommercial Partners and Agreements—Biofrontera Pharma and Biofrontera Bioscience” in this prospectus for more information. Under the Ameluz LSA, we hold the exclusive license to sell Ameluz® and the BF-RhodoLED® lamp for all indications currently approved by the FDA as well as all future FDA-approved indications. As further described below, under the Ameluz LSA, further extensions of the approved indications for Ameluz® photodynamic therapy in the United States are anticipated.

 

Our second prescription drug 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 adults and children 2 months and older. We are currently selling Xepi® for this indication in the U.S. under an exclusive license and supply agreement, or Xepi LSA, with Ferrer that was assumed by Biofrontera on March 25, 2019 through our acquisition of Cutanea Life Sciences, Inc. See “BusinessCommercial Partners and Agreements—Ferrer” in this prospectus for more information. Acquisition details are described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Key factors affecting our performance—Cutanea Life Sciences, Inc. Transactions” section within this prospectus.

 

As mentioned above, on March 25, 2019, we acquired Cutanea from Maruho Co., Ltd. In November 2018, Cutanea had just launched Xepi®, a prescription cream for the treatment of impetigo. The acquisition of Cutanea Life Sciences, Inc. in March 2019 has enabled us to market an FDA-approved drug that has already been introduced in the U.S. market. We believe that Xepi® has the potential to be another innovative product with a large market potential in our portfolio.

 

1
 

 

 

As a licensee, we rely on our licensors to conduct clinical trials in order to pursue extensions to the current product indications approved by the FDA. Currently, Biofrontera AG (through its wholly owned subsidiary Biofrontera Bioscience GmbH) is conducting or preparing for the following development pipeline with respect to our flagship licensed product Ameluz® and the BF-RhodoLED® lamp:

 

        Clinical Phase    
Product    Indication / comments   Territory   Pre-clinical   I   II   III   Submission    Status 
Ameluz®   AK: Pharmacokinetics study   US                     FDA submission in Q1/2021. In addition to this study, the FDA requires a safety study in order to allow larger treatment fields
RhodoLED® XL   Illumination of larger body regions   US                     FDA submission in Q1/2021 and FDA resubmission in Q2/2021
Ameluz®   Basal cell carcinoma   US                     Phase III ongoing
Ameluz®   Moderate to severe acne   US                       Phase II in preparation
Ameluz®   AK: Face and Scalp with pain-reducing illumination protocol   US                       Phase III in preparation
Ameluz®   AK: Trunk & extremities   US                       Phase III in preparation
Ameluz®   Squamous cell carcinoma in situ   EU/US                       Phase III in preparation

  

We are unaware of any immediate or near-term plans of Ferrer for a US-market focused development pipeline.

 

Our Strategy

 

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

 

  expanding our sales in the United States of Ameluz® in combination with the BF-RhodoLED® lamp for the treatment of minimally to moderately thick actinic keratosis of the face and scalp and positioning Ameluz® to be a leading photodynamic therapy product 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 product; and
     
  leveraging the potential for future approvals and label extensions of our licensed portfolio products that are in the pipeline for the U.S. market through the LSAs with the Licensors.

 

Company History and Management Team

 

We were formed in March 2015 as Biofrontera Inc., a Delaware corporation, a wholly-owned subsidiary of Biofrontera AG. Our Chairman and Chief Executive Officer is Professor Hermann Lübbert Ph.D. Prof. Dr. Lübbert founded Biofrontera AG in 1997 and has been managing the Company ever since.

 

As depicted in the organizational chart below and described in “Business—Group structure”, prior to the consummation of this initial public offering, we are a member of the “Biofrontera Group” which consists of a parent company, Biofrontera AG, and five wholly owned subsidiaries, including us.

 

 

Biofrontera AG is a holding company that is responsible for the management, strategic planning, internal control and risk management of its subsidiaries and ensures the necessary financing needs are met. Biofrontera Bioscience GmbH carries out research and development tasks as well as all regulatory functions for the Biofrontera Group and holds the Ameluz® patents, the international approvals for Ameluz®, and the combination approval for Ameluz® and the BF-RhodoLED® lamp in the US. Pursuant to a license agreement with Biofrontera Bioscience GmbH, Biofrontera Pharma GmbH, which is also the holder of the patents and CE certificate of the BF-RhodoLED® lamp, bears the responsibility for the production, further licensing and marketing of Biofrontera Group’s approved products. Biofrontera Inc. is responsible for the marketing of all Biofrontera Group products in the United States, including the licensed drug Xepi®.

 

Upon consummation of the initial public offering, we will no longer be a wholly owned subsidiary of Biofrontera AG. However, Biofrontera AG will continue to hold         % of the outstanding shares of our common stock. In addition, we have entered into an agreement enabling us to continue to use the Biofrontera Group’s IT resources as well as into a shared services agreement that provides access to the Biofrontera Group’s resources with respect to quality management, regulatory affairs and medical affairs.

 

Summary Risk Factors

 

Investing in our common stock involves substantial risk. Our ability to execute our strategy is also subject to certain risks. The risks described under the heading “Risk Factors” included elsewhere in this prospectus may cause us not to realize the full benefits of our strengths or may cause us to be unable to successfully execute all or part of our strategy. Some of the most significant challenges and risks include the following:

 

  Currently, our sole source of revenue are sales of products we license from other companies. If we fail to comply with our obligations in the agreements under which we license rights from third parties, or if the license agreements are terminated for other reasons, we could lose license rights that are important to our business.

 

 

2
 

 

 

  Certain important patents for our licensed product Ameluz® expired in 2019. Although the process of developing generic topical dermatological products for the first time presents specific challenges that may deter potential generic competitors, generic versions of Ameluz® may enter the market following the recent expiration of these patents. If this happens, we may need to reduce the price of Ameluz® significantly and may lose significant market share.
     
  Our business depends substantially on the success of our principal licensed product Ameluz®. If the Biofrontera Group is unable to successfully obtain and maintain regulatory approvals or reimbursement for Ameluz® for existing and additional indications, our business may be materially harmed.
     
 

The Biofrontera Group currently depends on a single unaffiliated contract manufacturer to manufacture Ameluz® and has recently contracted with a second unaffiliated contract manufacturer to begin producing Ameluz®. If Biofrontera AG fails to maintain its relationships with these manufacturers or if both of these manufacturers are unable to produce product for Biofrontera AG, our business could be materially harmed.

     
  If our Licensors’ manufacturing partners fail to manufacture Ameluz®, BF-RhodoLED® lamps, Xepi® or other marketed products in sufficient quantities and at acceptable quality and cost levels, or to fully comply with current good manufacturing practice, or cGMP, or other applicable manufacturing regulations, we may face a bar to, or delays in, the commercialization of the products under license to us or we will be unable to meet market demand, and lose potential revenues.
     
  The Biofrontera Group is currently involved in lawsuits to defend or enforce patents related to our licensed products and they or another licensor may become involved in similar suits in the future, which could be expensive, time-consuming and unsuccessful.
     
  The COVID-19 global pandemic has continued to negatively affect our sales and operations and may continue to do so.
     
  We are fully dependent on our collaboration with the Biofrontera Group for our supply of Ameluz® and BF-RhodoLED® lamps and future development of the Ameluz® product line, on our collaboration with Ferrer for our supply of Xepi® and future development of Xepi® and may depend on the Biofrontera Group, Ferrer or additional third parties for the supply, development and commercialization of future licensed product candidates. Subject to the Ameluz LSA, which gives us authority under certain circumstances to take over clinical development, regulatory work and manufacturing from our collaborators should they be unable or unwilling to perform these functions appropriately, our current and future collaborators control the sourcing and manufacture of our licensed products as well as the regulatory approvals and clinical trials related to our licensed products. Our lack of control over some of these functions could adversely affect our ability to implement our strategy for the commercialization of our licensed products.
     
  Insurance coverage and medical expense reimbursement may be limited or unavailable in certain market segments for our licensed products, which could make it difficult for us to sell our licensed products.
     
  Healthcare legislative changes may have a material adverse effect on our business and results of operations.
     
  We face significant competition from other pharmaceutical and medical device companies and our operating results will suffer if we fail to compete effectively. We also must compete with existing treatments, such as simple curettage and cryotherapy, which do not involve the use of a drug but have gained significant market acceptance.
     
  We have a history of operating losses and anticipate that we will continue to incur operating losses in the future and may never sustain profitability.
     
  If we fail to obtain additional financing, we may be unable to complete the commercialization of Xepi® and other products we may license.
     
  We have identified a material weakness in our internal control over financial reporting, resulting from a control deficiency related to the oversight of third-party service providers. 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 controls, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect our business and stock price.
     
  Biofrontera AG will beneficially own            % of our stock after the completion of the initial public offering and will be able to exert significant control over matters subject to stockholder approval.
     
 

We expect that, immediately after this offering, we will be a “controlled company” within the meaning of Nasdaq listing standards, and as a controlled company we will qualify for exemptions from certain corporate governance requirements. We will have the opportunity to elect any of the exemptions afforded a controlled company.

 

 

3
 

 

 

Our Corporate Information

 

We were incorporated in March 2015 and commenced operations in May 2016. Our first commercial product launch was in October 2016. Our corporate headquarters are located at 120 Presidential Way, Suite 330, Woburn, Massachusetts 01801. Our telephone number is 781-245-1325. Our principal website address is www.biofrontera-us.com. The information on or accessed through our website is not incorporated in this prospectus or the registration statement of which this prospectus forms a part.

 

Implications of Being an Emerging Growth Company and a Smaller Reporting Company

 

We qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. An emerging growth company may take advantage of certain reduced reporting and other requirements that are otherwise generally applicable to public companies. As a result:

 

  we are permitted to provide only two years of audited financial statements and Management’s Discussion and Analysis of Financial Condition and Results of Operations disclosure in any registration statement or report prior to the filing of our first annual report on Form 10-K;
     
  we are not required to engage an auditor to report on our internal control over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act;
     
  we are not required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board, or the PCAOB, regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (i.e., critical audit matters);
     
  we are not required to submit certain executive compensation matters to stockholder advisory votes, such as “say-on-pay,” “say-on-frequency” and “say-on-golden parachutes;” and
     
  we are not required to comply with certain disclosure requirements related to executive compensation, such as the requirement to disclose the correlation between executive compensation and performance and the requirement to present a comparison of our Chief Executive Officer’s compensation to our median employee compensation.

 

We may take advantage of these reduced reporting and other requirements until the last day of our fiscal year following the fifth anniversary of the completion of this offering, or such earlier time that we are no longer an emerging growth company. However, if certain events occur prior to the end of such five-year period, including if we have greater than or equal to $1.07 billion in annual gross revenue, have greater than or equal to $700 million in market value of our common stock held by non-affiliates, or issue more than $1.0 billion of non-convertible debt over a three-year period, we will cease to be an emerging growth company prior to the end of such five-year period. We may choose to take advantage of some but not all of these reduced burdens. We have elected to adopt the reduced requirements with respect to our financial statements and Management’s Discussion and Analysis of Financial Condition and Results of Operations disclosure in this prospectus. As a result, the information that we provide to stockholders may be different from the information you may receive from other public companies in which you hold equity.

 

In addition, under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards until such time as those standards apply to private companies. We have elected to take advantage of the longer phase-in periods for the adoption of new or revised financial accounting standards under the JOBS Act until we are no longer an emerging growth company. Our election to use the phase-in periods permitted by this election may make it difficult to compare our financial statements to those of non-emerging growth companies and other emerging growth companies that have opted out of the longer phase-in periods permitted under the JOBS Act and who will comply with new or revised financial accounting standards. If we were to subsequently elect instead to comply with public company effective dates, such election would be irrevocable pursuant to the JOBS Act.

 

We are also a “smaller reporting company” as defined in the rules promulgated under the Securities Exchange Act of 1934, as amended, or the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as our voting and non-voting common stock held by non-affiliates on the last business day of our second fiscal quarter is less than $250.0 million, or our annual revenue is less than $100.0 million during the most recently completed fiscal year and our voting and nonvoting common stock held by non-affiliates on the last business day of our second fiscal quarter in that fiscal year is less than $700.0 million.

 

 

4
 

 

 

The offering

 

     
Common stock offered by us                 shares.
     
Underwriters’ over-allotment option                 shares.
     
     
Common stock to be outstanding after this offering               shares.
     
Use of proceeds  

We estimate, based upon an assumed initial public offering price of $            per share (which is the midpoint of the price range set forth on the cover page of this prospectus), that we will receive net proceeds from this offering of approximately $              million, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

 

We currently estimate that we will use the net proceeds from this offering for general corporate purposes, including working capital and continued investments in our growth strategies described in “BusinessOur Strategy.” See “Use of Proceeds.”

     

Lock-up agreements

 

We and our directors and executive officers have agreed, subject to certain exceptions, not to sell, transfer or dispose of any shares of our common stock, or securities convertible into, exchangeable or exercisable for any shares of our common stock for a period of one hundred eighty (180) days after the completion of this offering without the prior written consent of the representative.

     

Controlled company

 

Immediately after this offering, assuming an offering size set forth above, Biofrontera AG, our parent company and sole existing stockholder, will own approximately       % of our outstanding shares of common stock. As a result, we expect to remain a “controlled company” within the meaning of the corporate governance standards of The Nasdaq Stock Market LLC (“Nasdaq”). See “Principal Stockholders.”

     
Risk factors   See “Risk Factors” beginning on page 8 and the other information included in this prospectus for a discussion of factors you should carefully consider before deciding to invest in shares of our common stock.
     
Proposed Nasdaq Capital Market symbol   “BFRI”

 

The number of shares of common stock to be outstanding after this offering is based on 8,000,000 shares of our common stock outstanding as of March 31, 2021, and excludes:

 

                      shares of common stock available for future issuance under the 2021 Omnibus Incentive Plan as of                           ;

 

Unless we indicate otherwise or the context otherwise requires, all information in this prospectus assumes or gives effect to:

 

 

the underwriters do not exercise their over-allotment option;

     
  the filing and effectiveness of our amended and restated certificate of incorporation and the adoption of our amended and restated bylaws, each of which will occur immediately prior to the closing of this offering; and
     
  an initial public offering price of $           per share of common stock, which is the midpoint of the range set forth on the cover page of this prospectus.

 

 

5
 

 

 

Summary Financial Data

 

The following tables present our summary financial data. We have derived the summary statements of operations data for the years ended December 31, 2019 and 2020 and the summary balance sheet data as of December 31, 2019 and 2020 from our audited financial statements included elsewhere in this prospectus. We have derived the summary statements of operations data for the three months ended March 31, 2020 and 2021 and the summary balance sheet data as of March 31, 2021 from our unaudited financial statements included elsewhere in this prospectus. You should read this data together with our financial statements and related notes included elsewhere in this prospectus and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Our historical results for any prior period are not necessarily indicative of our future results. The summary financial data in this section are not intended to replace our financial statements and related notes included elsewhere in this prospectus.

 

Statement of Operations Data:
(U.S. dollars in thousands except share and
  Year ended December 31,   Three months ended March 31, 

per share data)

 

2019

  

2020

  

2020

  

2021

 
Product revenues, net  $26,131   $18,787   $4,608   $4,731 
Related party revenues   50    62    15    13 
Total revenues, net   26,181    18,849    4,623    4,744 
Operating expenses:                    
Cost of revenues, related party   11,330    8,313    2,268    2,408 
Cost of revenues, other   1,078    753    119    163 
Selling, general and administrative   28,041    17,706    5,884    4,758 
Selling, general and administrative, related party   654    411    99    164 
Restructuring costs   3,531    1,132    312    281 
Change in fair value of contingent consideration   962    140    (262)   498 
Total operating expenses   45,596    28,455    8,420    8,272 
Loss from operations   (19,415)   (9,606)   (3,797    (3,528)
Other income (expense)                    
Interest expense, net   (2,134)   (2,869)   (660)   (84)
Bargain purchase gain   5,710    -    -    - 
Other income, net   4,890    1,552    354    79 
Total other income (expense)   8,466    (1,317)   (306)   (5)
Loss before income taxes   (10,949)   (10,923)   (4,103)   (3,533)
Income tax expenses   33    64    1    1 
Net loss  $(10,982)  $(10,987)  $(4,104)  $(3,534)
                     
Basic and diluted net loss per share  $(10,981.99)  $(479.48)  $(4,104.40)  $(0.44)
                     
(Shares used in computing basic and diluted loss per share)   1,000    22,915    1,000    8,000,000 

 

 

6
 

 

 

Balance Sheet Data:   As of March 31, 2021  
(U.S. dollars in thousands except share and per share data)   Actual     As adjusted  
Cash and cash equivalents   $ 4,637          
Accounts receivable, net     1,742        
Accounts receivable, related party     168        
Inventories     8,425        
Prepaid expenses and other current assets     1,130        
Non-current assets     4,694                
Total assets   $ 20,796          
Accounts payable     483          
Accounts payable, related parties     332          
Accrued expenses and other current liabilities     3,235          
Long-term liabilities     14,452          
Total liabilities   $ 18,502          
Total stockholders’ equity   $ 2,294          

 

See Note 19, Net Loss per Share to our financial statements for a description of the method used to compute basic and diluted net loss per common share.

 

The as adjusted data reflect (i) the sale of             shares of common stock in this offering at an assumed initial public offering price of $        per share, after deducting underwriting discounts and commissions and estimated offering expenses.

 

A $1.00 increase (decrease) in the assumed initial public offering price of $             per share, would increase (decrease) the net proceeds to us from this offering by approximately $                 , assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting underwriting discounts and commissions and estimated offering expenses payable by us.

 

 

7
 

 

RISK FACTORS

 

Investing in our common stock involves a high degree of risk. You should carefully consider the risks described below, as well as the other information in this prospectus, including our financial statements and the related notes and the section “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” before deciding whether to invest in our common stock. The occurrence of any of the events or developments described below could materially and adversely affect our business, financial condition, results of operations and growth prospects. In such an event, the market price of our common stock could decline, and you may lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our business operations.

 

Our business is subject to a number of risks and uncertainties. The following is a summary of the principal risk factors described in this section:

 

Risks Related to the License and Supply Agreements and our Licensed Products

 

  Currently, our sole source of revenue are sales of products we license from other companies. If we fail to comply with our obligations in the agreements under which we license rights from third parties, or if the license agreements are terminated for other reasons, we could lose license rights that are important to our business.
  Certain important patents for our licensed product Ameluz® expired in 2019. Although the process of developing generic topical dermatological products for the first time presents specific challenges that may deter potential generic competitors, generic versions of Ameluz® may enter the market following the recent expiration of these patents. If this happens, we may need to reduce the price of Ameluz® significantly and may lose significant market share.
  Our business depends substantially on the success of our principal licensed product Ameluz®. If Biofrontera AG or the Biofrontera Group is unable to successfully obtain and maintain regulatory approvals or reimbursement for Ameluz® for existing and additional indications, our business may be materially harmed.
 

The Biofrontera Group currently depends on a single unaffiliated contract manufacturer to manufacture Ameluz® and has recently contracted with a second unaffiliated contract manufacturer to begin producing Ameluz®. If Biofrontera AG fails to maintain its relationships with these manufacturers or if both of these manufacturers are unable to produce product for Biofrontera AG, our business could be materially harmed.

  If our Licensors’ manufacturing partners fail to manufacture Ameluz®, BF-RhodoLED® lamps, Xepi® or other marketed products in sufficient quantities and at acceptable quality and cost levels, or to fully comply with current good manufacturing practice, or cGMP, or other applicable manufacturing regulations, we may face a bar to, or delays in, the commercialization of the products under license to us or we will be unable to meet market demand, and lose potential revenues.
  The Biofrontera Group is currently involved in lawsuits to defend or enforce patents related to our licensed products and they or another licensor may become involved in similar suits in the future, which could be expensive, time-consuming and unsuccessful.

 

Risks Related to Our Business and Strategy

 

  The COVID-19 global pandemic has continued to negatively affect our sales and operations and may continue to do so.
  Insurance coverage and medical expense reimbursement may be limited or unavailable in certain market segments for our licensed products, which could make it difficult for us to sell our licensed products.
  We are fully dependent on our collaboration with the Biofrontera Group for our supply of Ameluz® and BF-RhodoLED® lamps and future development of the Ameluz® product line, on our collaboration with Ferrer for our supply of Xepi® and future development of Xepi® and may depend on the Biofrontera Group, Ferrer or additional third parties for the supply, development and commercialization of future licensed product candidates. Subject to the Ameluz LSA. which gives us authority under certain circumstances to take over clinical development, regulatory work and manufacturing from our collaborators should they be unable or unwilling to perform these functions appropriately, our current and future collaborators control the sourcing and manufacture of our licensed products as well as the regulatory approvals and clinical trials related to our licensed products. Our lack of control over some of these functions could adversely affect our ability to implement our strategy for the commercialization of our licensed products.
  Healthcare legislative changes may have a material adverse effect on our business and results of operations.
  We face significant competition from other pharmaceutical and medical device companies and our operating results will suffer if we fail to compete effectively. We also must compete with existing treatments, such as simple curettage and cryotherapy, which do not involve the use of a drug but have gained significant market acceptance.

 

8
 

 

  The U.S. market size for Ameluz® for the treatment of actinic keratosis may be smaller than we have estimated.
  If our Licensors face allegations of noncompliance with the law and encounter sanctions, their reputation, revenues and liquidity may suffer, and our licensed products could be subject to restrictions or withdrawal from the market.
  Even if our Licensors obtain regulatory approvals for our licensed products and product candidates, or approvals extending their indications, they may not gain market acceptance among hospitals, physicians, health care payors, patients and others in the medical community.
  A recall of our licensed drug or medical device products, or the discovery of serious safety issues with our licensed drug or medical device products, could have a significant negative impact on us.
  Our licensed medical device product, the BF-RhodoLED® lamp, is subject to extensive governmental regulation, and failure to comply with applicable requirements could cause our business to suffer.
  We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may be unable to successfully implement our business strategy.
  Our business and operations would suffer in the event of system failures, cyber-attacks or a deficiency in our cyber-security.

 

Risks Related to Our Financial Position and Capital Requirements

 

  We have a history of operating losses and anticipate that we will continue to incur operating losses in the future and may never sustain profitability.
  If we fail to obtain additional financing, we may be unable to complete the commercialization of Xepi® and other products we may license.

 

Risks Related to Being a Public Company

 

  We have identified a material weakness in our internal control over financial reporting, resulting from a control deficiency related to the oversight of third-party service providers. 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 controls, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect our business and stock price.
  We will incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to compliance with our public company responsibilities and corporate governance practices.
  As a result of becoming a public company, we will be obligated to develop and maintain proper and effective internal controls over financial reporting and any failure to maintain the adequacy of these internal controls may adversely affect investor confidence in our company and, as a result, the value of our common shares.
  We are an emerging growth company and we cannot be certain if the reduced disclosure requirements applicable to emerging growth companies will make our common stock less attractive to investors.

 

Risks Related to This Offering and the Ownership of Our Common Stock

 

  Biofrontera AG will beneficially own     % of our stock after the completion of the initial public offering and will be able to exert significant control over matters subject to stockholder approval.
 

We expect that, immediately after this offering, we will be a “controlled company” within the meaning of Nasdaq listing standards, and as a controlled company we will qualify for exemptions from certain corporate governance requirements. We will have the opportunity to elect any of the exemptions afforded a controlled company.

  Future sales and issuances of our common stock or rights to purchase our common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause the stock price of our common stock to decline.
  Our charter documents and Delaware law could prevent a takeover that stockholders consider favorable and could also reduce the market price of our stock.
  Our amended and restated certificate of incorporation that will become effective immediately prior to the closing of this offering provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.

 

9
 

  

Risks Related to the License and Supply Agreements and Our Licensed Products

 

Currently, our sole source of revenue are sales of products we license from other companies. If we fail to comply with our obligations in the agreements under which we license rights from third parties, or if the license agreements are terminated for other reasons, we could lose license rights that are important to our business.

 

We are a party to license agreements with Biofrontera Pharma and Biofrontera Bioscience (for Ameluz®) and with Ferrer (for Xepi®) and expect to enter into additional licenses in the future. Our existing license agreements impose, and we expect that future license agreements will impose, on us various development, regulatory diligence obligations, payment of milestones or royalties and other obligations. If we fail to comply with our obligations under our license agreements, or we are subject to a bankruptcy or insolvency, the licensor may have the right to terminate the license. In the event that any of our existing or future important licenses were to be terminated by the licensor, we would likely need to cease further commercialization of the related licensed product or be required to spend significant time and resources to modify the licensed product to not use the rights under the terminated license. In the case of marketed products that depend upon a license agreement, we could be required to cease our commercialization activities, including sale of the affected product.

 

Disputes may arise between us and any of our Licensors regarding intellectual property subject to such agreements, including:

 

  the scope of rights granted under the agreement and other interpretation-related issues;
  whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the agreement;
  our right to sublicense patent and other rights to third parties;
  our diligence obligations with respect to the use of the licensed intellectual property, and what activities satisfy those diligence obligations;
  the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our Licensors and us, should any such joint creation occur;
  our right to transfer or assign the license; and
 

the effects of termination.

 

These  or other disputes over intellectual property that we have licensed may prevent or impair our ability to maintain our current arrangements on acceptable terms, or may impair the value of the arrangement to us. Any such dispute, or termination of a necessary license, could have a material adverse effect on our business, financial condition and results of operations

 

Certain important patents for our licensed product Ameluz® expired in 2019. Although the process of developing generic topical dermatological products for the first time presents specific challenges that may deter potential generic competitors, generic versions of Ameluz® may enter the market following the recent expiration of these patents. If this happens, we may need to reduce the price of Ameluz® significantly and may lose significant market share.

 

The patent family that protected the technology relating to nanoemulsion of 5-aminolevulinic acid, the active ingredient in Ameluz®, against copying by competitors expired on November 12, 2019. This patent family included U.S. Patent No. 6,559,183, which, prior to its expiration, served as a material, significant and possibly the only barrier to entry into the U.S. market by generic versions of Ameluz®. Although the process of developing generic topical dermatological products presents specific challenges that may deter potential generic competitors, Patent No. 6,559,183 no longer prevents generic versions of Ameluz® from entering the U.S. market and competing with Ameluz®. If generic competitors do enter the market, this may cause a significant drop in the price of Ameluz® and, therefore, a significant drop in our profits. We may also lose significant U.S. market share for Ameluz®.

 

10
 

  

Biofrontera Bioscience holds another patent family protecting the technology relating to nanoemulsions for which they have been issued patents in various jurisdictions and which expires in December 2027. A corresponding U.S. patent application has been filed by Biofrontera Bioscience but is still pending. We cannot guarantee that this U.S. patent will be issued or, if issued, will adequately protect us against copying by competitors. See “Business—Intellectual Property” for more information on the patents held by Biofrontera Bioscience.

 

Our business depends substantially on the success of our principal licensed product Ameluz®. If the Biofrontera Group is unable to successfully obtain and maintain regulatory approvals or reimbursement for Ameluz® for existing and additional indications, our business may be materially harmed.

 

Although Biofrontera Bioscience has received marketing approval in the United States for Ameluz® for lesion- and field-directed treatment of actinic keratosis, there remains a significant risk that we will fail to generate sufficient revenue or otherwise successfully commercialize the product in the United States. The success of our product will depend on several factors, including:

 

  successful completion of further clinical trials by the Biofrontera Group;
  receipt by the Biofrontera Group of further regulatory approvals, including for the marketing of Ameluz® for additional indications;
  the contract manufacturing facility maintaining regulatory compliance;
  compliance with applicable law for our sales force and marketing efforts;
  the contract manufacturing facility manufacturing sufficient quantities in acceptable quality;
  the Biofrontera Group sourcing sufficient quantities of raw materials used to manufacture our licensed products;
  continued acceptable safety and effectiveness profiles for our licensed products;
  the Biofrontera Group obtaining and maintaining patent and trade secret protection and regulatory exclusivity; and
  the Biofrontera Group protecting its intellectual property rights.

 

If the Biofrontera Group does not achieve one or more of these factors in a timely manner, or at all, we could experience significant delays or an inability to successfully commercialize our licensed products, which would materially harm our business and we may not be able to earn sufficient revenue and cash flows to continue our operations.

 

Because Biofrontera Bioscience received approval from the FDA to market in the United States Ameluz® in combination with photodynamic therapy using the BF-RhodoLED® lamp, any new lamp we may license would require new approval from the FDA. We cannot assure you that the Biofrontera Group will develop this new lamp or obtain any such new approval.

 

The Biofrontera Group currently depends on a single unaffiliated contract manufacturer to manufacture Ameluz® and has recently contracted with a second unaffiliated contract manufacturer to begin producing Ameluz®. If Biofrontera AG fails to maintain its relationships with these manufacturers or if both of these manufacturers are unable to produce product for Biofrontera AG, our business could be materially harmed.

 

Pursuant to the Ameluz LSA, Biofrontera Pharma supplies us with Ameluz®. The Biofrontera Group currently depends on a single unaffiliated contract manufacturer located in Switzerland to manufacture Ameluz®, Glaropharm AG, and has recently signed an agreement with a second unaffiliated contract manufacturer located in Germany, Pharbil Waltrop GmbH, to begin to supply Biofrontera Pharma with Ameluz® to ensure stability of the supply chain. If the Biofrontera Group fails to maintain its relationships with both of these manufacturers or if the Biofrontera Group fails to maintain its relationship with its current manufacturer and the second manufacturer has not yet completed the necessary steps to begin manufacturing Ameluz®, the Biofrontera Group may be unable to obtain an alternative manufacturer of Ameluz® that could deliver the quantity of the product at the quality and cost levels that we require. Even if an acceptable alternative manufacturer could be found, we would expect long delays in transitioning the manufacturing from the existing manufacturer to a new manufacturer. Problems of this kind could cause us to experience order cancellations and loss of market share. The failure of either manufacturer to supply Biofrontera Pharma with Ameluz® that satisfies quality, quantity and cost requirements in a timely manner could impair our ability to deliver Ameluz® to the U.S. market and could increase costs, particularly if the Biofrontera Group is unable to obtain Ameluz® from alternative sources on a timely basis or on commercially reasonable terms. In addition, each manufacturer is regulated by the country in which they are located and by the FDA and must comply with applicable laws and regulations. Finding a suitable replacement of these particular partners would therefore be extremely difficult for the Biofrontera Group. If the Biofrontera Group lost these manufacturers, this could have a material adverse effect on our business, prospects, financial condition and/or results of operations. If the suppliers fail to comply, this could harm our business. For the avoidance of doubt, following the consummation of the initial public offering, we will continue to rely on Biofrontera Pharma as our sole supplier of Ameluz® and the BF-RhodoLED® lamps, pursuant to the Ameluz LSA.

 

11
 

 

If our Licensors’ manufacturing partners fail to manufacture Ameluz®, BF-RhodoLED® lamps, Xepi® or other marketed products in sufficient quantities and at acceptable quality and cost levels, or to fully comply with current good manufacturing practice, or cGMP, or other applicable manufacturing regulations, we may face a bar to, or delays in, the commercialization of the products under license to us or we will be unable to meet market demand, and lose potential revenues.

 

Pursuant to the applicable LSA, our Licensors supply us with the licensed product that we sell in the U.S. market. The manufacture of the products we license requires significant expertise and capital investment. Currently, all commercial supply for each of our commercial products is currently manufactured by single unaffiliated contract manufacturers. Our Licensors would each need to spend substantial time and expense to replace their respective contract manufacturer if it failed to deliver products in the quality and quantities we demand or failed to meet any regulatory or cGMP requirements. Our Licensors take precautions to help safeguard their respective manufacturing facilities, including acquiring insurance and performing on site audits. However, vandalism, terrorism or a natural or other disaster, such as a fire or flood, could damage or destroy manufacturing equipment or the inventory of raw material or finished goods, cause substantial delays in operations, result in the loss of key information, and cause additional expenses. Our Licensors’ insurance may not cover losses related to our licensed products in any particular case. In addition, regardless of the level of insurance coverage, damage to our Licensors’ facilities may have a material adverse effect on our business, financial condition and operating results.

 

Our Licensors’ manufacturing partners must comply with federal, state and foreign regulations, including FDA regulations governing cGMP enforced by the FDA through its facilities inspection program and by similar regulatory authorities in other jurisdictions where we do business. These requirements include, among other things, quality control, quality assurance and the maintenance of records and documentation. For the medical device products we license, our Licensors are required to comply with the FDA’s Quality System Regulation, or QSR, which covers the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of our medical device products.

 

Our Licensors’ contract facilities have been inspected by the FDA for cGMP compliance. If our Licensors’ contract manufacturers do not successfully maintain cGMP compliance for these facilities, commercialization of our licensed products could be prohibited or significantly delayed. Even after cGMP compliance has been achieved, the FDA or similar foreign regulatory authorities at any time may implement new standards or change their interpretation and enforcement of existing standards for manufacture, packaging, testing of or other activities related to our licensed products. For our licensed commercialized medical device product, the FDA audits compliance with the QSR through periodic announced and unannounced inspections of manufacturing and other facilities. The FDA may conduct inspections or audits at any time. Similar audit rights exist in Europe and other foreign jurisdictions. Any failure to comply with applicable cGMP, QSR and other regulations may result in fines and civil penalties, suspension of production, product seizure or recall, imposition of a consent decree, or withdrawal of product approval, and would limit the availability of our product. Any manufacturing defect or error discovered after products have been produced and distributed also could result in significant consequences, including adverse health consequences, injury or death to patients, costly recall procedures, re-stocking costs, warning letters, Form 483 reports, civil monetary penalties, product liability, damage to our reputation and potential for product liability claims. If our Licensors are required to find a new manufacturer or supplier, the process would likely require prior FDA and/or equivalent foreign regulatory authority approval and would be very time consuming. An inability to continue manufacturing adequate supplies of our licensed products at any contract facilities could result in a disruption in the supply of our licensed products. Delay or disruption in our ability to meet demand may result in the loss of potential revenue.

 

12
 

 

In addition, we are subject to regulations in various jurisdictions, including the Federal Drug Quality and Security Act and the Drug Supply Chain Security Act in the United States, that require us to develop electronic systems to serialize, track, trace and authenticate units of our licensed products through the supply chain and distribution system. Compliance with these regulations may result in increased expenses for our company or impose greater administrative burdens on our organization, and failure to meet these requirements could result in fines or other penalties.

 

Failure to comply with all applicable regulatory requirements may subject our company to operating restrictions and criminal prosecution, monetary penalties and other disciplinary actions, including, sanctions, warning letters, product seizures, recalls, fines, injunctions, suspension, shutdown of production, revocation of approvals or the inability to obtain future approvals, or exclusion from future participation in government healthcare programs. Any of these events could disrupt our company’s business and, consequently, have a material adverse effect on our revenue, profitability and financial condition.

 

If our Licensors’ efforts to protect the proprietary nature of their intellectual property related to our licensed products are not adequate, we may not be able to compete effectively in our market.

 

Our Licensors rely upon a combination of patents, trade secret protection and confidentiality agreements to protect the intellectual property related to the products we license from them. Any disclosure to or misappropriation by third parties of their confidential proprietary information could enable competitors to quickly duplicate or surpass their technological achievements, thus eroding our competitive position in our market.

 

In addition, the patent applications that they own may fail to result in issued patents in the United States. Even if the patents do successfully issue, third parties may challenge the validity, enforceability or scope thereof, which may result in such patents being narrowed, invalidated or held unenforceable. Furthermore, even if they are unchallenged, their patents and patent applications may not adequately protect their intellectual property or prevent others from designing around their claims. If the breadth or strength of protection provided by the issued patents and patent applications our Licensors hold with respect to our licensed products is threatened, it could threaten our ability to commercialize our licensed products. Further, if our Licensors encounter delays in their clinical trials, the period of time during which we could market our licensed products under patent protection would be reduced. Since patent applications in the United States are confidential for a period of time after filing, we cannot be certain that our Licensors were the first to file any patent application related to the products we license. Furthermore, for applications in which all claims are entitled to a priority date before March 16, 2013, an interference proceeding can be provoked by a third party or instituted by the U.S. Patent and Trademark Office, or USPTO, to determine who was the first to invent any of the subject matter covered by the patent claims of our applications. For applications containing a claim not entitled to priority before March 16, 2013, there is greater level of uncertainty in the patent law with the passage of the America Invents Act (2012) which brings into effect significant changes to the U.S. patent laws that are yet untried and untested, and which introduces new procedures for challenging pending patent applications and issued patents. A primary change under this reform is creating a “first to file” system in the United States. This will require us to be cognizant going forward of the time from invention to filing of a patent application.

 

13
 

 

In addition to the protection afforded by patents, our Licensors seek to rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable, processes for which patents are difficult to enforce and any other elements of our product discovery and development processes that involve proprietary know-how, information or technology that is not covered by patents. Although our Licensors require their employees to assign their inventions to us to the extent permitted by law, and require our employees, consultants, advisors and any third parties who have access to our proprietary know-how, information or technology to enter into confidentiality agreements, we cannot be certain that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. Furthermore, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States or the EU. As a result, we may encounter significant problems in protecting and defending our intellectual property both in the United States, in the EU and in other countries. If we are unable to prevent unauthorized material disclosure of our intellectual property to third parties, we may not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, operating results and financial condition.

 

Third party claims of intellectual property infringement may affect our ability to sell our licensed products and may also prevent or delay our Licensors’ product discovery and development efforts.

 

Our commercial success depends in part on our Licensors avoiding infringement of the patents and proprietary rights of third parties. There is a substantial amount of litigation involving patents and other intellectual property rights in the biotechnology and pharmaceutical industries, as well as administrative proceedings for challenging patents, including interference and reexamination proceedings before the USPTO, or oppositions and other comparable proceedings in foreign jurisdictions. Recently, following U.S. patent reform, new procedures including inter partes review and post grant review have been implemented. This reform includes changes in law and procedures that are untried and untested and will bring uncertainty to the possibility of challenge to our patents in the future. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are developing our product candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our licensed products may give rise to claims of infringement of the patent rights of others.

 

Third parties may assert that we or our Licensors are employing their proprietary technology without authorization. There may be third party patents of which our Licensors are currently unaware with claims to materials, formulations, devices, methods of manufacture or methods for treatment related to the use or manufacture of the products we license. Because patent applications can take many years to issue, there may be currently pending patent applications which may later result in issued patents that our product candidates may infringe. In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon such patents. If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of our licensed products, any molecules formed during the manufacturing process or any final product itself, the holders of any such patents may be able to block our ability to commercialize the product unless we obtained a license under the applicable patents, or until such patents expire or they are finally determined to be held invalid or unenforceable. Similarly, if any third-party patent were held by a court of competent jurisdiction to cover aspects of our formulations, processes for manufacture or methods of use, including combination therapy or patient selection methods, the holders of any such patent may be able to block our ability to develop and commercialize the product unless we obtained a license or until such patent expires or is finally determined to be held invalid or unenforceable. In either case, such a license may not be available on commercially reasonable terms or at all. If we are unable to obtain a necessary license to a third-party patent on commercially reasonable terms, or at all, our ability to commercialize our licensed products may be impaired or delayed, which could in turn significantly harm our business.

 

14
 

 

Parties making claims against us may seek and obtain injunctive or other equitable relief, which could effectively block our ability to sell our licensed products and to further commercialize our licensed products. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign our infringing products, which may be impossible or require substantial time and monetary expenditure. We cannot predict whether any such license would be available at all or whether it would be available on commercially reasonable terms. Furthermore, even in the absence of litigation, our Licensors may need to obtain licenses from third parties to advance their research or allow commercialization of the products we license. We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In that event, we would be unable to further develop and commercialize our licensed products, which could harm our business significantly.

 

In March 2018, DUSA Pharmaceuticals, Inc., or DUSA, brought a lawsuit against Biofrontera AG and its subsidiaries, including us, before the District Court of Massachusetts due to alleged infringement of its patents No. 9,723,991 and No. 8,216,289 by sales of BF-RhodoLED® lamps in the United States. In July 2018, DUSA amended its complaint to add claims of trade secret misappropriation, tortious interference with contractual relations, and deceptive and unfair trade practices. We cannot guarantee that the outcome will be successful. The Biofrontera Group has incurred in the past, and expects to incur in the future, significant expenses in defending these claims, and we expect to have to divert significant employee resources, including management resources, to defend the claims. This may have a material adverse effect on our business, prospects, financial condition and/or results of operations.

 

The Biofrontera Group is currently involved in lawsuits to defend or enforce patents related to our licensed products and they or another licensor may become involved in similar suits in the future, which could be expensive, time-consuming and unsuccessful.

 

Competitors may infringe upon the patents for our licensed products. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that one or more of our patents is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation or defense proceedings, including our litigation against DUSA as described above, could put one or more of our patents at risk of being invalidated, held unenforceable, or interpreted narrowly and could put our patent applications at risk of not issuing. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a successful claim or counterclaim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign our infringing products, which may be impossible or require substantial time and monetary expenditure.

 

Interference or derivation proceedings provoked by third parties or brought by the USPTO may be necessary to determine the priority of inventions with respect to our patents or patent applications. An unfavorable outcome in our litigation against DUSA or other patent related litigation could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms. Litigation or interference proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees. We may not be able to prevent misappropriation of our trade secrets or confidential information, particularly in countries where the laws may not protect those rights as fully as in the United States or the EU.

 

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Furthermore, because of the substantial amount of discovery that could be required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our shares.

 

The trade secrets of our Licensors are difficult to protect.

 

Confidentiality agreements with employees and others may not adequately prevent disclosure of our Licensors’ trade secrets and other proprietary information and may not adequately protect their intellectual property.

 

Our success depends upon the skills, knowledge and experience of our Licensors’ scientific and technical personnel, consultants and advisors as well as our partners, Licensors and contractors. Because drug development is a highly competitive technical field, our Licensors rely in part on trade secrets to protect their proprietary technology and processes. However, trade secrets are difficult to protect. We enter into confidentiality agreements with our Licensors, corporate partners, employees, consultants and other advisors. These agreements typically require that the receiving party keep confidential and not disclose to third parties all confidential information developed by the receiving party or made known to the receiving party during the course of the receiving party’s relationship.

 

Our Licensors’ trade secrets also could be independently discovered by their competitors, in which case, they would not be able to prevent use of such trade secrets by their competitors. The enforcement of a claim alleging that a party illegally obtained and was using our trade secrets could be difficult, expensive and time consuming and the outcome would be unpredictable. There exists a risk that we or our Licensors may not be able to detect when misappropriation of trade secrets has occurred or where a third party is using such trade secrets without our or their knowledge. The failure to obtain or maintain meaningful trade secret protection could adversely affect the competitive position of our licensed products.

 

Certain third-party employees and our licensed patents are subject to foreign laws.

 

A majority of the employees of Biofrontera AG work in Germany and are subject to German employment law. Ideas, developments, discoveries and inventions made by such employees and consultants are subject to the provisions of the German Act on Employees’ Inventions, which regulates the ownership of, and compensation for, inventions made by employees. We face the risk that disputes can occur between Biofrontera AG and its employees or former employees pertaining to alleged non-adherence to the provisions of this act that may impact our license whether Biofrontera AG prevails or fails in any such dispute. There is a risk that the compensation Biofrontera AG provided to employees who assign patents to them may be deemed to be insufficient and Biofrontera AG may be required under German law to increase the compensation due to such employees for the use of the patents. In those cases where employees have not assigned their interests to Biofrontera AG, we may need to pay compensation for the use of those patents. If Biofrontera AG is required to pay additional compensation or face other disputes under the German Act on Employees’ Inventions, the impact on our license could adversely affect our results of operations.

 

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Our international dealings with our Licensors may pose currency risks, which may adversely affect our operating results and net income.

 

Our operating results may be affected by volatility in currency exchange rates and our ability to effectively manage our currency transaction risks. In general, we conduct our business with our Licensors and our third-party manufacturers in the local currency of the country in which such licensor or contract manufacturer operates. We do not manage our foreign currency exposure in a manner that would eliminate the effects of changes in foreign exchange rates. Therefore, changes in exchange rates between these foreign currencies, the dollar and the euro will affect our cost of revenues, related party, and operating margins, and could result in exchange losses in any given reporting period. Based on certain assumptions relating to our operations (which assumptions may prove incorrect) and our internal models, we believe that, with respect to the fiscal year ended December 31, 2020, an average 10% appreciation of the U.S. dollar against the euro would have resulted in an increase of approximately $0.2 million in our other income, net for such period, whereas we believe that an average 10% depreciation of the U.S. dollar against the euro would have resulted in a decrease of approximately $0.2 million in our other income, net during such period.

 

Given the volatility of exchange rates, we can give no assurance that we will be able to effectively manage our currency transaction risks or that any volatility in currency exchange rates will not have an adverse effect on our results of operations.

 

Risks Related to Our Business and Strategy

 

The COVID-19 global pandemic has continued to negatively affect our sales and operations and may continue to do so.

 

Since the beginning of 2020, COVID-19 has become a global pandemic. As a result of the measures implemented by governments around the world, Biofrontera’s business operations have been directly affected. In particular, there has been a significant decline in demand for Biofrontera’s products in the United States as a result of different priorities for medical treatments that emerged during the COVID-19 pandemic, thereby causing a delay of many dermatological treatments and diagnosis. Revenue from product sales for the year ended December 31, 2020 has declined by about 28.0% when compared to the year ended December 31, 2019. Although our revenue from product sales for the three months ended March 31, 2021 has increased 2.2% when compared to the three months period ended March 31, 2020, we cannot guarantee that this trend will continue. See “Management’s Discussion and Analysis of Financial Condition and Results of Operation—Key factors affecting our performance—COVID-19” for more information on the impact of the COVID-19 pandemic on our operations. As long as the impact of the COVID-19 pandemic continues, we may experience disruptions that could severely impact our business, operations, sales and marketing, as well as our Licensors’ preclinical studies and clinical trials, including:

 

  decreases in demand for our licensed products due to reduced numbers of in-person meetings with prescribers, and patient visits with physicians, resulting in fewer new prescriptions and reduced demand for products used in procedures;
  impacts due to travel limitations and mobility restrictions;
  delays, difficulties or postponement in conducting our Licensors’ clinical trials;
  limitations in employee resources that would otherwise be focused on the conduct of our sales and marketing activities, including because of sickness of employees or their families or the desire of employees to avoid contact with other individuals.

 

Although our company has implemented comprehensive cost reductions, emergency plans to maintain central processes and activities to protect employees, there can be no guarantee that these measures will be able to offset the impact of COVID-19 on business and operations of Biofrontera in the long term.

 

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Due to the COVID-19 pandemic, it is currently impossible to make reliable forecasts about the future performance of our business. The direct and indirect effects of the pandemic have had a negative impact on the Company’s liquidity position as the pandemic develops as a result of declines or delays in the treatments for which our licensed products are used resulting in a steep decrease in revenue for us. The extent to which the COVID-19 pandemic will continue to impact our business, research and development efforts, clinical trials, prospects for regulatory approval for new indications for the products we license, sales, marketing and other operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak, the extent and duration of travel restrictions and social distancing in the United States, business closures or business disruptions and the effectiveness of vaccines and other actions taken to contain and treat the disease. In addition, a recession or market correction resulting from the spread of the COVID-19 pandemic could materially affect our business prospects and the value of our shares.

 

We are fully dependent on our collaboration with the Biofrontera Group for our supply of Ameluz® and BF-RhodoLED® lamps and future development of the Ameluz® product line, on our collaboration with Ferrer for our supply of Xepi® and future development of Xepi® and may depend on the Biofrontera Group, Ferrer or additional third parties for the supply, development and commercialization of future licensed product candidates. Subject to the Ameluz LSA, which gives us authority under certain circumstances to take over clinical development, regulatory work and manufacturing from our collaborators should they be unable or unwilling to perform these functions appropriately, our current and future collaborators control the sourcing and manufacture of our licensed products as well as the regulatory approvals and clinical trials related to our licensed products. Our lack of control over some of these functions could adversely affect our ability to implement our strategy for the commercialization of our licensed products.

 

We do not own or operate manufacturing facilities for clinical or commercial manufacture of any of our licensed products. We outsource all manufacturing and packaging of our licensed products to our Licensors, who may in turn contract with third parties to provide these services. We have no direct control over the manufacturing process of our licensed products. This lack of control may increase quality or reliability risks and could limit our ability to quickly increase or decrease production rates. See “—If our Licensors’ manufacturing partners fail to manufacture Ameluz®, BF-RhodoLED® lamps, Xepi® or other marketed products in sufficient quantities and at acceptable quality and cost levels, or to fully comply with current good manufacturing practice, or cGMP, or other applicable manufacturing regulations, we may face a bar to, or delays in, the commercialization of the products under license to us or we will be unable to meet market demand, and lose potential revenues” for more information on the risks related to the manufacture of our licensed products. Although under the Ameluz LSA we are entitled to enter into a direct agreement with Biofrontera Pharma’s supplier under certain circumstances, there is no guarantee that we will be able to do so under terms similar to Biofrontera Pharma’s existing agreement or without delays or difficulties, each of which could have an adverse impact on our business or results of operations.

 

We currently do not have the ability to conduct any clinical trials. Under the Ameluz LSA and the Xepi LSA, our Licensors’ control clinical development as well as the regulatory approval process for our licensed products. Our lack of control over the clinical development and regulatory approval process for our licensed products could result in delays or difficulties in the commercialization of our licensed products and/or affect the development of future indications for our licensed products. Although under the Ameluz LSA we are entitled to take over clinical trial and regulatory work under certain circumstances and subtract the cost of the trials from the transfer price of Ameluz®, there is no guarantee that we will be able to do so without delays or difficulties that could have an adverse impact on our business or results of operations.

 

In addition, under the Ameluz LSA and the Xepi LSA, we are not obligated or tasked with the duty to defend the intellectual property related to our licensed products and rely on our Licensors to defend the relevant intellectual property. This lack of control may increase the litigation risks and could limit our ability to utilize the relevant intellectual property. See “—If our Licensors’ efforts to protect the proprietary nature of their intellectual property related to our licensed products are not adequate, we may not be able to compete effectively in our market” for more information on the risks related to the defense of the intellectual property related to our licensed products.

 

Biofrontera AG is currently the sole shareholder of the Company and following the consummation of the initial public offering will remain a significant shareholder of the Company and, as a result of its control of the manufacture, clinical development and regulatory approval of Ameluz® may exert greater influence on the Company relative to the percentage of its ownership of the Company’s common stock. See “—Risks Related to This Offering and Ownership of Our Common Stock— Biofrontera AG will beneficially own -% of our stock after the completion of the initial public offering and will be able to exert significant control over matters subject to stockholder approval, and its interests may conflict with ours or yours in the future” for more information on the risks related to Biofrontera AG’s beneficial ownership of the Company’s common stock following the initial public offering.

 

Insurance coverage and medical expense reimbursement may be limited or unavailable in certain market segments for our licensed products, which could make it difficult for us to sell our licensed products.

 

Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which products they will cover and the amount of reimbursement. Reimbursement by a third-party payor may depend upon a number of factors, including the government or third-party payor’s determination that use of a product is:

 

  a covered benefit under its health plan;
  safe, effective and medically necessary;
  reasonable and appropriate for the specific patient;
  cost-effective; and
  neither experimental nor investigational.

 

Obtaining coverage and reimbursement approval for a product from a government or other third-party payor is a time consuming and costly process that could require our Licensors to provide to the payor supporting scientific, clinical and cost-effectiveness data for the use of our licensed products. Our Licensors may not be able to provide data sufficient to gain acceptance with respect to coverage and reimbursement or a particular reimbursement amount. If reimbursement of future products or extended indications for existing licensed products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, we may be unable to achieve or sustain profitability.

 

Healthcare legislative changes may have a material adverse effect on our business and results of operations.

 

In the United States and certain other countries, there have been a number of legislative and regulatory changes to the health care system that could impact our ability to sell our licensed products profitably. In particular, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 revised the payment methodology for many products under Medicare in the United States, which has resulted in lower rates of reimbursement. In 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively, the Affordable Care Act, was enacted. On January 20, 2017, President Donald Trump signed an executive order stating that the administration intended to seek prompt repeal of the Affordable Care Act, and, pending repeal, directed by the U.S. Department of Health and Human Services and other executive departments and agencies to take all steps necessary to limit any fiscal or regulatory burdens of the Affordable Care Act. On January 28, 2021, President Joseph R. Biden, Jr. signed the Executive Order on Strengthening Medicaid and stated his administration’s intentions to reverse the actions of his predecessor and strengthen the Affordable Care Act. As part of this Executive Order, the Department of Health and Human Services, United States Treasury, and the Department of Labor are to review all existing regulations, orders, guidance documents, policies, and agency actions to consider if they are consistent with ensuring both coverage under the Affordable Care Act and if they make high-quality healthcare affordable and accessible to Americans. At this time we are unsure what effect the new administration’s policies or this executive order will have. There is significant uncertainty about the future of the Affordable Care Act in particular and healthcare laws generally in the United States. The continued expansion of the government’s role in the U.S. healthcare industry may further lower rates of reimbursement for pharmaceutical products. We are unable to predict the likelihood of changes to the Affordable Care Act or other healthcare laws which may negatively impact our profitability.

 

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President Biden intends, as his predecessor did, to take action against drug prices which are considered “high.” The most likely time to address this would be in the reauthorization of the Prescription Drug User Fee Act (PDUFA) 2022 as part of a package bill. Drug pricing continues to be a subject of debate at the executive and legislative levels of U.S. government and we expect to see legislation focusing on this in the coming year. The American Rescue Plan Act of 2021 signed into law by President Biden on March 14, 2021 includes a provision that will eliminate the statutory cap on rebates drug manufacturers pay to Medicaid beginning in January 2024. With the elimination of the cap, manufacturers may be required to compensate states in an amount greater than what the state Medicaid programs pay for the drug.

 

The Affordable Care Act is a sweeping law intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for healthcare and the health insurance industry, impose new taxes and fees on the healthcare industry and impose additional health policy reforms. This law revises the definition of “average manufacturer price” for reporting purposes, which could increase the amount of Medicaid drug rebates to states once the provision is effective. Further, the law imposes a significant annual fee on companies that manufacture or import branded prescription drug products. Substantial new provisions affecting compliance have also been enacted, which may require us to modify our business practices with healthcare practitioners.

 

Some of the provisions of the Affordable Care Act have yet to be fully implemented, while certain provisions have been subject to judicial and Congressional challenges. Thus, the full impact of the Affordable Care Act, any law replacing elements of it, or the political uncertainty surrounding its repeal or replacement on our business remains unclear. Such developments may materially adversely affect the prices we are able to receive for our licensed products or otherwise materially adversely affect our ability to profitably commercialize our licensed products in the United States.

 

Other legislative changes have been proposed and adopted in the United States since the Affordable Care Act was enacted. On August 2, 2011, the Budget Control Act of 2011, among other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2012 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions of Medicare payments to providers up to 2% per fiscal year. The American Taxpayer Relief Act of 2012, or the ATRA, among other things, reduced Medicare payments to several providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. The current U.S. administration continues to focus heavily on drug pricing issues and Congress has introduced a multitude of legislative proposals aimed at drug pricing. For example, the Prescription Drug Pricing Reduction Act of 2019 proposes to, among other things, penalize pharmaceutical manufacturers for raising prices on drugs covered by Medicare Parts B and D faster than the rate of inflation, cap out-of-pocket expenses for Medicare Part D beneficiaries, and proposes a number of changes to how drugs are reimbursed in Medicare Part B. A similar drug pricing bill, the Elijah E. Cummings Lower Drug Costs Now Act proposes to enable direct price negotiations by the federal government on certain drugs (with the maximum price paid by Medicare capped based on an international index), requires manufacturers to offer these negotiated prices to other payers, and restricts manufacturers from raising prices on drugs covered by Medicare Parts B and D. In May 2019, Centers for Medicare & Medicaid Services, or CMS, issued a final rule requiring drug manufacturers to include certain drug price information in television advertisements for products that are covered by Medicare and Medicaid. The final rule was struck down by a federal district court in July 2019. The ruling is being appealed and there is no assurance as to whether we will be required to comply with the price transparency requirements. We cannot predict whether any proposed legislation will become law and the effect of these possible changes on our business cannot be predicted at this time.

 

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In addition to legislative proposals, Congressional Committees have requested certain manufacturers provide specific documents and detailed information regarding drug pricing practices. If we become the subject of any government investigation with respect to our drug pricing, marketing, or other business practices, we could incur significant expense and could be distracted from operation of our business and execution of our strategy. Any such investigation could also result in reduced market acceptance and demand for our licensed products, could harm our reputation and our ability to market our licensed products in the future, and could have a material adverse effect on our business, financial condition, results of operations and growth prospects. At the state level, there are similar new laws and ongoing ballot initiatives that create additional pressure on our drug pricing and may also affect how our licensed products are covered and reimbursed. A number of states have adopted or are considering various pricing actions, such as those requiring pharmaceutical manufacturers to publicly report proprietary pricing information, limit price increases or place a maximum price ceiling or cap on certain products. Existing and proposed state pricing laws have added complexity to the pricing of drugs and may already be impacting industry pricing decisions.

 

We expect continued significant focus on health care and drug pricing legislation. There have been, and likely will continue to be, legislative and regulatory proposals at the U.S. federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. We cannot predict the initiatives that may be adopted in the future. Additionally, third-party payors, including governmental payors, managed care organizations and private health insurers, are increasingly challenging the prices charged for medical products and services and examining their cost effectiveness. The continuing efforts of governments, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect:

 

  the demand for our licensed products, if our Licensors obtain regulatory approvals;
  our ability to set a price or obtain reimbursement that we believe is fair for our licensed products;
  our ability to generate revenues and achieve or maintain profitability; and
  the level of taxes that we are required to pay.

 

Any denial or reduction in reimbursement from Medicare or other programs or governments may result in a similar denial or reduction in payments from private payors, which may adversely affect our future profitability.

 

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To date, we have a relatively short history of sales of our licensed products in the United States.

 

We have limited relatively short history of sales of our licensed products to date. The Biofrontera Group launched the commercialization of Ameluz® and the BF-RhodoLED® lamp for actinic keratosis in the United States in October 2016 and we have a limited history of marketing our licensed products in the United States. In addition, we began marketing the drug Xepi® in the United States following our acquisition of Cutanea in March 2019 and have a limited history of marketing Xepi® in the United States. While our licensed products have gained acceptance in the markets we serve, our licensed products may never generate substantial revenue or profits for us. We must establish a larger market for our licensed products and build that market through marketing campaigns to increase awareness of, and confidence by doctors in, our licensed products. We expect this may be even more challenging in the near term as a result of current measures and regulations implemented by governments worldwide in an attempt to control the COVID-19 pandemic, which we predict may continue to lead to declining demand in some of our markets in the foreseeable future for Biofrontera’s products as different priorities for medical treatments emerge, thereby causing a delay of actinic keratosis treatment for most patients. If we are unable to expand our current customer base and obtain market acceptance of our licensed products, our operations could be disrupted and our business may be materially adversely affected. Even if we achieve profitability, we may not be able to sustain or increase profitability.

 

Competing products and future emerging products may erode sales of our licensed products.

 

Reimbursement issues affect the economic competitiveness of our licensed products as compared to other therapies. See “—Insurance coverage and medical expense reimbursement may be limited or unavailable in certain market segments for our licensed products, which could make it difficult for us to sell our licensed products.”

 

Our industry is subject to rapid, unpredictable and significant technological change and intense competition. Our competitors may succeed in developing, acquiring, or licensing on an exclusive basis, products that are safer, more effective or more desirable than ours. Many of our competitors have substantially greater financial, technical and marketing resources than we have. In addition, several of these companies have significantly greater experience than we do in developing products, conducting preclinical and clinical testing, obtaining regulatory approvals to market products for health care, and marketing healthcare products.

 

Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated in our competitors. Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries.

 

We cannot guarantee that new drugs or future developments in drug technologies will not have a material adverse effect on our business. Increased competition could result in price reductions, lower levels of government or other third-party reimbursements, failure to achieve market acceptance and loss of market share, any of which could adversely affect our business, results of operations and financial condition. Further, we cannot give any assurance that developments by our competitors or future competitors will not render our technologies obsolete or less advantageous.

 

We face significant competition from other pharmaceutical and medical device companies and our operating results will suffer if we fail to compete effectively. We also must compete with existing treatments, such as simple curettage and cryotherapy, which do not involve the use of a drug but have gained significant market acceptance.

 

The pharmaceutical and medical device industry is characterized by intense competition and rapid innovation. Our competitors may be able to develop other products that are able to achieve similar or better results for the treatment of actinic keratosis. We expect that our future competitors will include mostly established pharmaceutical companies, such as Sun Pharma (DUSA) and Galderma. Most of our competitors have substantially greater financial, technical and other resources, such as larger research and development staffs and experienced marketing and manufacturing organizations and well-established sales forces. Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries.

 

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Our competitors may succeed in developing, acquiring or licensing products that are more effective or less costly than our licensed products and product candidates. In addition, our licensed products compete with other therapies, such as simple curettage and, particularly in the United States, cryotherapy, which do not involve the use of a drug but have gained significant market acceptance.

 

If we are not able to compete effectively with the competitors and competing therapies, we may lose significant market share in the relevant markets, which could have a material adverse effect on our revenue, results of operations and financial condition.

 

If we are unable to maintain effective marketing and sales capabilities or enter into agreements with third parties to market and sell our licensed products, we may be unable to generate revenue growth.

 

In order to grow the market for our licensed products, especially a newer licensed product like Xepi®, we must continue to build our marketing, sales and distribution capabilities in the United States. The development and training of our sales force and related compliance plans to market our licensed products are expensive and time consuming and can potentially delay the growth of sales of our licensed products. In the event we are not successful in expanding our marketing and sales infrastructure, we may not be able to successfully grow the market our licensed products, which would limit our revenue growth.

 

The U.S. market size for Ameluz® for the treatment of actinic keratosis may be smaller than we have estimated.

 

The public data regarding the market for actinic keratosis treatments in the United States may be incomplete. Therefore some of our estimates and judgments are based on various sources which we have not independently verified and which potentially include outdated information, or information that may not be precise or correct, potentially rendering the U.S. market size for treatment of actinic keratosis with Ameluz® smaller than we have estimated, which may reduce our potential and ability to increase sales of Ameluz® and revenue in the United States. Although we have not independently verified the data obtained from these sources, we believe that such data provide the best available information relating to the present market for actinic keratosis treatments in the United States, and we often use such data for our business and planning purposes.

 

If our Licensors face allegations of noncompliance with the law and encounter sanctions, their reputation, revenues and liquidity may suffer, and our licensed products could be subject to restrictions or withdrawal from the market.

 

Any government investigation of alleged violations of the law could require our Licensors to expend significant time and resources in response and could generate negative publicity. Any failure to comply with ongoing regulatory requirements may significantly and adversely affect our ability to commercialize and generate revenues from our licensed products. If regulatory sanctions are applied or if regulatory approval is withdrawn, the value of our company and our operating results will be adversely affected. Additionally, if we are unable to generate revenues from our product sales, our potential for achieving profitability will be diminished and the capital necessary to fund our operations will be increased.

 

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Even if our Licensors obtain regulatory approvals for our licensed products, or approvals extending their indications, they may not gain market acceptance or become widely accepted among hospitals, physicians, health care payors, patients and others in the medical community.

 

In May 2016, Biofrontera Bioscience GmbH received approval from the FDA to market in the United States. Ameluz® in combination with photodynamic therapy using the BF-RhodoLED® lamp for lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity on the face and scalp. We launched the commercialization of Ameluz® and the BF-RhodoLED® lamp for actinic keratosis in the United States in October 2016. Even with regulatory approval, Ameluz® may not receive wide acceptance among hospitals, physicians, health care payors, patients and others in the medical community. In addition, Xepi® received approval from the FDA in 2017 and may not gain market acceptance over time. Market acceptance of any of our licensed products depends on a number of factors, including:

 

  the clinical indications for which they are approved, including any restrictions placed upon the product in connection with its approval, such as patient registry or labeling restriction;
  the product labeling, including warnings, precautions, side effects, and contraindications that the FDA or other regulatory authorities approve;
  the potential and perceived advantages of our product candidates over alternative products or therapies;
  relative convenience and ease of administration;
  the effectiveness and compliance of our sales and marketing efforts;
  acceptance by major operators of hospitals, physicians and patients of our licensed products or candidates as a safe and effective treatment;
  the prevalence and severity of any side effects;
  product labeling or product insert requirements of the FDA or other regulatory authorities;
  any Risk Evaluation and Mitigation Strategy that the FDA might require for our drug product candidates;
  the timing of market introduction of our product candidates as well as competitive products;
  the perceived advantages of our licensed products over alternative treatments;
  the cost of treatment in relation to alternative products; and
  the availability of adequate reimbursement and pricing by third party payors and government authorities, including any conditions for reimbursement required by such third-party payors and government authorities.

 

If our licensed products and product candidates are approved, and/or receive label extensions, but fail to achieve market acceptance among physicians, patients, payors, or others in the medical community, we will not be able to generate significant revenues, which would have a material adverse effect on our business, prospects, financial condition and results of operations.

 

With respect to our licensed products, we may be subject to healthcare laws, regulation and enforcement. Our failure to comply with those laws could have a material adverse effect on our results of operations and financial condition.

 

We may be subject to additional healthcare regulation and enforcement by the U.S. federal government and by authorities in the United States. Such U.S. laws include, without limitation, state and federal anti-kickback, federal false claims, privacy, security, financial disclosure laws, anti-trust, Physician Payment Sunshine Act reporting and fair trade regulation and advertising laws and regulations. Many states and other jurisdictions have similar laws and regulations, some of which are broader in scope. If our operations are found to be in violation of any of such laws or any other governmental regulations that apply to us, we may be subject to penalties, including, but not limited to, civil and criminal penalties, damages, fines, the curtailment or restructuring of our operations, the exclusion from participation in federal, state or other healthcare programs and imprisonment, any of which could adversely affect our ability to operate our business and our financial results.

 

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Increased Health and Human Services, Office of Inspector General (OIG), scrutiny on the sale of products through specialty pharmacies or through physician practices by means of direct investigation or by issuance of unfavorable Opinion Letters which may curtail or hinder the sales of our licensed products based on risk of enforcement upon ourselves or our buyers. The OIG continues to make modifications to existing Anti-Kickback Statute, or AKS, safe harbors which may increase liability and risk for our company as well as adversely impact sales relationships. On November 20, 2020, OIG issued the final rule for Safe Harbors under the Federal AKS. This new final rule creates additional safe harbors including ones pertaining to patient incentives. OIG is able to modify safe harbors as well as regulatory compliance requirements which could impact out business adversely.

 

The majority of states also have statutes or regulations similar to these federal laws, which apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payer. In addition, some states have laws that require pharmaceutical companies to adopt comprehensive compliance programs. Certain states also mandate the tracking and require reporting of gifts, compensation, and other remuneration paid by us to physicians and other health care providers.

 

In September 2010, OIG issued a Special Advisory Bulletin to notify drug manufacturers that OIG intended to pursue enforcement actions against drug manufacturers that failed to submit timely average manufacturer price, or AMP, and average sales price, or ASP, information. The Medicaid Drug Rebate Program requires manufacturers to enter into and have in effect a national rebate agreement with the Secretary of Health and Human Services in order for Medicaid payments to be available for the manufacturer’s covered outpatient drugs. Companies with such rebate agreements are required to submit certain drug pricing information to CMS, including quarterly and monthly pricing data. There has been an increased level of federal enforcement against drug manufacturers that have failed to provide timely and accurate pricing information to the government. Since September 2010, OIG has settled 13 cases against drug manufacturers relating to drug price reporting issues, totaling approximately $18.5 million. We expect continued enforcement directed at companies that fail to make accurate and timely price reports. If we were found to make the required pricing disclosures, we could incur significant expense and delay.

 

A recall of our licensed drug or medical device products, or the discovery of serious safety issues with our licensed drug or medical device products, could have a significant negative impact on us.

 

The FDA and other relevant regulatory agencies have the authority to require or request the recall of commercialized products in the event of material deficiencies or defects in design or manufacture or in the event that a product poses an unacceptable risk to health. Manufacturers may, under their own initiative, recall a product. A government-mandated or voluntary recall by us or one of our distributors could occur as a result of an unacceptable risk to health, component failures, manufacturing errors, design or labeling defects or other deficiencies and issues. Recalls of our licensed products would divert managerial and financial resources and have an adverse effect on our and our Licensors’ reputation, financial condition and operating results, which could impair our Licensors’ ability to produce our licensed products in a cost-effective and timely manner.

 

Further, under the FDA’s medical device reporting, or MDR, regulations, our Licensors are required to report to the FDA any event which reasonably suggests that our licensed product may have caused or contributed to a death or serious injury or in which our licensed product malfunctioned and, if the malfunction of the same or similar device marketed by us were to recur, would likely cause or contribute to death or serious injury. The FDA also requires reporting of serious, life-threatening, unexpected and other adverse drug experiences and the submission of periodic safety reports and other information. Product malfunctions or other adverse event reports may result in a voluntary or involuntary product recall and other adverse actions, which could divert managerial and financial resources, impair our Licensors’ ability to manufacture our licensed products in a cost-effective and timely manner and have an adverse effect on our reputation, financial condition and operating results.

 

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Any adverse event involving our licensed products could result in future voluntary corrective actions, such as recalls or customer notifications, or regulatory agency action, which could include inspection, mandatory recall or other enforcement action. Any corrective action, whether voluntary or involuntary, will require the dedication of our Licensors’ time and capital, distract our Licensors’ management from operating their business and may harm our and our Licensors’ reputation and financial results as well as threaten our marketing authority for such products.

 

Our licensed medical device product, the BF-RhodoLED® lamp, is subject to extensive governmental regulation, and failure to comply with applicable requirements could cause our business to suffer.

 

The medical device industry in the United States is regulated extensively by governmental authorities, principally the FDA and corresponding state agencies. The regulations are very complex and are subject to rapid change and varying interpretations. Regulatory restrictions or changes could limit our ability to carry on or expand our operations or result in higher than anticipated costs or lower than anticipated sales. The FDA and other U.S. governmental agencies regulate numerous elements of our and our Licensors’ business, including:

 

  product design and development;
  pre-clinical and clinical testing and trials;
  product safety;
  establishment registration and product listing;
  distribution;
  labeling, manufacturing and storage;
  pre-market clearance or approval;
  advertising and promotion;
  marketing, manufacturing, sales and distribution;
  relationships and communications with health care providers;
  adverse event reporting;
  market exclusivity;
  servicing and post-market surveillance; and
  recalls and field safety corrective actions.

 

The Biofrontera Group is also working to develop a new lamp, the “BF-RhodoLED® XL,” which, if approved by the FDA, would allow use of Ameluz® on larger surfaces. Management believes that this new lamp, if it is developed and approved, could provide new business growth opportunities for our company. In the United States, according to FDA guidance, products for PDT, such as Ameluz® gel and its corresponding lamp(s), must be approved as combination products that cover both the drug and the lamp. In May 2016, the Biofrontera Group received approval from the FDA to market in the United States Ameluz® in combination with photodynamic therapy using the BF-RhodoLED® lamp for lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity on the face and scalp. The applicable office of the FDA has determined that if Biofrontera develops a new lamp to be used with Ameluz®, Biofrontera AG must seek a new approval utilizing the “New Drug Application” procedure. As part of a drug/device combination, the lamp is by definition classified as a class III medical device and as such requires a premarket approval, or PMA, by the FDA. A new lamp will also require changes in the “Prescribing Information” of the drug. If Biofrontera AG develops this new lamp, once Biofrontera AG’s PMA application is submitted to the FDA as part of this approval process, it may take more than six months, plus, if needed, time required to answer questions or provide additional data. Prior to submission, the Biofrontera Group will need to perform final tests on the lamp prototype, including technical tests by a certified laboratory and a usability study. During the process, there is a risk that the FDA might ask for additional tests or even clinical trials, and there is no assurance that the Biofrontera Group will be able to satisfy the FDA’s requests for additional tests or trials in a timely manner, or at all, and there is no assurance that Biofrontera AG will be able to develop this new lamp, or obtain approval to use it in the United States for PDT treatment of actinic keratosis in combination with Ameluz.

 

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The FDA can delay, limit or deny clearance or approval of a device for many reasons, including:

 

  Biofrontera AG’s inability to demonstrate that its products are safe and effective for their intended uses or substantially equivalent to a predicate device;
  the data from Biofrontera AG’s clinical trials may not be sufficient to support clearance or approval; and
  the manufacturing process or facilities we use may not meet applicable requirements.

 

In addition, the FDA and other regulatory authorities may change their respective clearance and approval policies, adopt additional regulations or revise existing regulations, or take other actions which may prevent or delay approval or clearance of our licensed products under development or impact our ability to modify our currently cleared or approved products on a timely basis.

 

Any delay in, or failure to receive or maintain, clearance or approval for such products under development that we expect to license could prevent us from generating revenue from these products or achieving profitability. Additionally, the FDA and comparable foreign regulatory authorities have broad enforcement powers. Regulatory enforcement or inquiries, or other increased scrutiny of us, could dissuade some customers from using our licensed products and adversely affect our reputation and the perceived safety and efficacy of our licensed products.

 

Failure to comply with applicable regulations could jeopardize our ability to sell our licensed products and result in enforcement actions against our Licensors such as fines, civil penalties, injunctions, warning letters, Form 483 reports, recalls of products, delays in the introduction of products into the market, refusal of the FDA or other regulators to grant future clearances or approvals, and the suspension or withdrawal of existing approvals by the FDA or other regulators. Any of these sanctions could result in higher than anticipated costs or lower than anticipated sales and have a material adverse effect on our reputation, business, financial condition and operating results.

 

As a result of our IT infrastructure, we are subject to governmental regulation and other legal obligations in the EU and European Economic Area, or EEA, related to privacy, data protection and data security and, as a result of our sales in California, the California Consumer Privacy Act (CCPA). Our actual or perceived failure to comply with such obligations could harm our business.

 

We are subject to diverse laws and regulations relating to data privacy and security in the EU and eventually in the EEA, including Regulation 2016/679, known as the GDPR. The GDPR applies extraterritorially and implements stringent operational requirements for controllers and processors of personal data. New global privacy rules are being enacted and existing ones are being updated and strengthened. We are likely to be required to expend capital and other resources to ensure ongoing compliance with these laws and regulations.

 

Complying with these numerous, complex and often changing regulations is expensive and difficult. Failure by us, any partners, our service providers, or our employees or contractors to comply with the GDPR could result in regulatory investigations, enforcement notices and/or fines of up to the higher of €20 million or up to 4% of our total worldwide annual revenue. In addition to the foregoing, a breach of privacy laws or data security laws, particularly those resulting in a significant security incident or breach involving the misappropriation, loss or other unauthorized use or disclosure of sensitive or confidential patient or consumer information, could have a material adverse effect on our business, reputation and financial condition.

 

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As a data controller, we are accountable for any third-party service providers we engage to process personal data on our behalf. We attempt to mitigate the associated risks by performing security assessments and due diligence of our vendors and requiring all such third-party providers with data access to sign agreements and obligating them to only process data according to our instructions and to take sufficient security measures to protect such data. There is no assurance that these contractual measures and our own privacy and security-related safeguards will protect us from the risks associated with the third-party processing, storage and transmission of such information. Any violation of data or security laws by our third-party processors could have a material adverse effect on our business and result in the fines and penalties outlined above.

 

Where we transfer personal data of EU citizens or anyone residing in the EU out of the EU and EEA, we do so in compliance with the relevant data export requirements from time to time. There is currently ongoing litigation challenging the commonly used transfer mechanism, the EU Commission approved model clauses. On July 16, 2020, the Court of Justice of the European Union, or CJEU, issued a judgment which annulled, without granting a grace or transition period, the European Commission’s Decision (EU) 2016/1250 of July 12, 2016 on the adequacy of the protection provided by the U.S. Privacy Shield (a mechanism for complying with data protection requirements when transferring personal data from the EU to the United States). Accordingly, such framework is not a valid mechanism to comply with EU data protection requirements when transferring personal data from the European Union to the United States. To the extent that we were to rely on the EU-U.S. Privacy Shield Framework, we will not be able to do so in the future, which could increase our costs and limit our ability to process personal data from the EU. The same decision also cast doubt on the viability of one of the primary alternatives to the U.S. Privacy Shield, namely, the European Commission’s Standard Contractual Clauses, as a vehicle for such transfers in all circumstances. Use of the standard contractual clauses must now be assessed on a case-by-case basis taking into account the legal regime applicable in the destination country, in particular applicable surveillance laws and rights of individuals and additional measures and/or contractual provisions may need to be put in place, however, the nature of these additional measures is currently uncertain. The CJEU went on to state that if a competent supervisory authority believes that the Standard Contractual Clauses cannot be complied with in the destination country and the required level of protection cannot be secured by other means, such supervisory authority is under an obligation to suspend or prohibit that transfer. At present, there are few, if any, viable alternatives to the Standard Contractual Clauses, and the law in this area remains dynamic. These changes may require us to find alternative bases for the compliant transfer of personal data outside the EEA and we are monitoring developments in this area.

 

We are also subject to evolving European privacy laws on cookies and on e-marketing. The EU is in the process of replacing the e-Privacy Directive (2002/58/EC) with a new set of rules taking the form of a regulation, which will be directly implemented in the laws of each European member state. The draft e-Privacy Regulation imposes strict opt-in marketing rules with limited exceptions for business-to-business communications, alters rules on third-party cookies, web beacons and similar technology and significantly increases fining powers to the greater of €20 million or 4% of total worldwide annual revenue. While the e-Privacy Regulation was originally intended to be adopted on May 25, 2018 (alongside the GDPR), it is still going through the European legislative process.

 

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The GDPR is directly applicable in each EU Member State, however, it provides that EU Member States may introduce further conditions, including limitations which could limit our ability to collect, use and share personal data (including health and medical information), or could cause our compliance costs to increase, ultimately having an adverse impact on our business. The GDPR imposes onerous accountability obligations requiring data controllers and processors to maintain a record of their data processing and implement policies as part of its mandated privacy governance framework. It also requires data controllers to be transparent and disclose to data subjects (in a concise, intelligible and easily accessible form) how their personal information is to be used, imposes limitations on retention of personal data; defines for the first time pseudonymized (i.e., key-coded) data; introduces mandatory data breach notification requirements; and sets higher standards for data controllers to demonstrate that they have obtained valid consent for certain data processing activities. In addition to the foregoing, a breach of the GDPR could result in regulatory investigations, reputational damage, orders to cease/change our use of data, enforcement notices, as well potential civil claims including class action type litigation where individuals suffer harm.

 

California recently enacted the California Consumer Privacy Act, or CCPA, which will, among other things, require new disclosures to California consumers and afford such consumers new abilities to opt out of certain sales of personal information, which went into effect on January 1, 2020. This Act also applies to any information of certain patients that a drug company may possess. It remains unclear what, if any, modifications will be made to this legislation or how it will be interpreted in the years to come. The effects of the CCPA potentially are significant, however, and may require us to modify our data processing practices and policies and to incur substantial costs and expenses in an effort to comply. As a general matter, compliance with laws, regulations, and any applicable rules or guidance from self-regulatory organizations relating to privacy, data protection, information security and consumer protection, may result in substantial costs and may necessitate changes to our business practices, which may compromise our growth strategy, adversely affect our ability to acquire customers, and otherwise adversely affect our business, financial condition and operating results. Noncompliance with CCPA could result in regulatory investigations, reputational damage, orders to cease/change our use of data, enforcement notices, as well potential civil claims including class action type litigation where individuals suffer harm.

 

We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may be unable to successfully implement our business strategy.

 

Our ability to compete in the highly competitive pharmaceutical industry depends upon our ability to attract and retain highly qualified managerial, scientific and medical personnel with specialized scientific and technical skills. We are highly dependent on our management, scientific, medical and operations personnel, including Professor Hermann Lübbert, chairman of our board and chief executive officer, and Erica Monaco, our chief financial and chief operating officer. The loss of the services of any of our executive officers or other key employees and our inability to find suitable replacements could potentially harm our business, prospects, financial condition or results of operations.

 

Despite our efforts to retain valuable employees, members of our management team may terminate their employment with us on short notice. Although we have employment agreements with our key employees, these employees could leave our employment at any time, with certain notice periods. We do not maintain “key man” insurance policies on the lives of these individuals or the lives of any of our other employees. Our success also depends on our ability to continue to attract, retain and motivate highly skilled junior, mid-level and senior managers as well as junior, mid-level and senior scientific and medical personnel and sales representatives.

 

Many of the other biotechnology and pharmaceutical companies that we compete against for qualified personnel have greater financial and other resources, different risk profiles and a longer history in the industry than we do. They may also provide more diverse opportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than what we can offer. If we are unable to continue to attract and retain high quality personnel, our ability to commercialize our licensed products will be limited.

 

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Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

 

We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional failures to comply with FDA regulations, provide accurate information to the FDA, comply with manufacturing standards we have established, comply with healthcare fraud and abuse laws and regulations, report financial information or data accurately or disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing and other abusive practices in the United States as well as in other jurisdictions where we conduct our business. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions, inability to obtain product approval and serious harm to our reputation. It is not always possible to identify and deter employee misconduct, and any precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions.

 

We will need to grow the size of our organization and we may experience difficulties in managing this growth.

 

As of December 31, 2020, we had 56 employees. In the longer term, as our development and commercialization plans and strategies develop, and as we continue operating as a public company, we expect to need additional managerial, operational, sales, marketing, financial and other personnel. Future growth would impose significant added responsibilities on members of management, including:

 

  identifying, recruiting, integrating, maintaining and motivating existing or additional employees; and
  improving our operational, financial and management controls, reporting systems and procedures.

 

Our future financial performance and our ability to commercialize and market our licensed products will depend, in part, on our ability to effectively manage any future growth, and our management may also have to divert a disproportionate amount of its attention away from day-to-day activities in order to devote a substantial amount of time to managing these growth activities. If we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors, we may not be able to successfully implement the tasks necessary to commercialize our licensed products and, accordingly, may not achieve our commercialization goals.

 

Due to our ongoing assessment of the size of the required sales force, we may be required to hire substantially more sales representatives to adequately support the commercialization and marketing of our licensed products or we may incur excess costs as a result of hiring more sales representatives than necessary. We may be competing with companies that currently have extensive and well-funded marketing and sales operations.

 

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Our business and operations would suffer in the event of system failures, cyber-attacks or a deficiency in our cyber-security.

 

Despite the implementation of security measures, our internal computer systems and those of our current and future contract and research organizations, or CROs, and other contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. The risk of a security breach or disruption, particularly through cyber-attacks or cyber-intrusion, including by computer hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. While we have not experienced any such material system failure, accident or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs and our business operations. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development and commercialization of our licensed products and product candidates could be delayed.

 

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our licensed products.

 

We face an inherent risk of product liability as a result of the clinical testing of our licensed products and face an even greater risk if we commercialize our licensed products on a larger scale. For example, we may be sued if our licensed products allegedly cause injury or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing; defects in design; a failure to warn of dangers inherent in the product, negligence, strict liability; and a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our licensed products and product candidates. Even a successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:

 

  costs to defend litigation and other proceedings;
  a diversion of management’s time and our resources;
  decreased demand for our licensed products;
  injury to our reputation;
  withdrawal of clinical trial participants;
  initiation of investigations by regulators;
  product recalls, withdrawals or labeling, marketing or promotional restrictions;
  loss of revenue;
  substantial monetary awards to trial participants or patients;
  exhaustion of any available insurance and our capital resources;
  the inability to commercialize our licensed products; and
  a decline in our share price.

 

We currently maintain product liability insurance. If such insurance is not sufficient, or if we are not able to obtain such insurance at an acceptable cost in the future, potential product liability claims could prevent or inhibit the commercialization of our licensed products and the products we develop. A successful claim could materially harm our business, financial condition or results of operations. Additionally, we cannot guarantee that continued product liability insurance coverage will be available in the future at acceptable costs.

 

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Failure to comply with the U.S. Foreign Corrupt Practices Act or other applicable anti-corruption legislation could result in fines, criminal penalties and an adverse effect on our business.

 

We do business with Licensors in a number of countries throughout the world. We are committed to doing business in accordance with applicable anti-corruption laws. We are subject, however, to the risk that our officers, directors, employees, agents and collaborators may take action determined to be in violation of such anti-corruption laws, including the U.S. Foreign Corrupt Practices Act of 1977, the U.K. Bribery Act 2010 and the European Union Anti-Corruption Act, as well as trade sanctions administered by the U.S. Office of Foreign Assets Control and the U.S. Department of Commerce. Any such violation could result in substantial fines, sanctions, civil and/or criminal penalties or curtailment of operations in certain jurisdictions and might adversely affect our results of operations. In addition, actual or alleged violations could damage our reputation and ability to do business.

 

Our licensed products will be subject to ongoing regulatory requirements and we may face future development, manufacturing and regulatory difficulties.

 

Our licensed drug products Ameluz® and Xepi® and any other drug products we license or acquire will be subject to ongoing regulatory requirements for labeling, packaging, storage, advertising, promotion, sampling, record-keeping, submission of safety and other post-market approval information, importation and exportation. In addition, approved products, manufacturers and manufacturers’ facilities are required to comply with extensive FDA requirements and the requirements of other similar regulatory authorities, including ensuring that quality control and manufacturing procedures conform to cGMP requirements.

 

Accordingly, we rely on our Licensors to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control. Our Licensors will also be required to report certain adverse reactions and production problems, if any, to the FDA and other similar regulatory authorities and to comply with certain requirements concerning advertising and promotion for our licensed products and potential products.

 

If a regulatory authority discovers previously unknown problems with a product, such as adverse events of unanticipated or unacceptable severity or frequency, or problems with the facility where the product is manufactured, or disagrees with the promotion, marketing or labeling of a product, it may impose restrictions on that product, including requiring withdrawal of the product from the market. If our licensed products or potential products fail to comply with applicable regulatory requirements, a regulatory authority may, among other actions against our Licensors or applicable third parties:

 

  issue warning letters or Form 483 (or similar) notices requiring our Licensors or applicable third parties to modify certain activities or correct certain deficiencies;
  require product recalls or impose civil monetary fines;
  mandate modifications to promotional materials or require our Licensors to provide corrective information to healthcare practitioners;
  require our Licensors or applicable third parties to enter into a consent decree or permanent injunction;
  impose other administrative or judicial civil or criminal actions, including monetary or other penalties, or pursue criminal prosecution;
  withdraw regulatory approval;
  refuse to approve pending applications or supplements to approved applications filed by our Licensors;
  impose restrictions on operations, including costly new manufacturing requirements; or
  seize or detain products.

 

To the extent that such adverse actions impact our rights under our license and supply agreements or otherwise restrict our ability to market our licensed products, they could adversely impact our business and results of operation.

 

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Generic manufacturers may launch products at risk of patent infringement.

 

If other manufacturers launch products to compete with our licensed products or product candidates in spite of our Licensors’ patent position, these manufacturers would likely erode our market and negatively impact our sales revenues, liquidity and results of operations.

 

Risks Related to Our Financial Position and Capital Requirements

 

We have a history of operating losses and anticipate that we will continue to incur operating losses in the future and may never sustain profitability.

 

We have incurred losses in each year since inception. Our net loss for the fiscal years ended December 31, 2019 and December 31, 2020 was $11.0 million and $11.0 million, respectively. Our net loss for the three months ended March 31, 2020 and 2021 was $4.1 million and $3.5 million, respectively. As of March 31, 2021, we had accumulated deficit of $44.7 million.

 

Our ability to become profitable depends on our ability to further commercialize our principal product Ameluz®. Even if we are successful in increasing our product sales, we may never achieve or sustain profitability. In the long term, we anticipate increasing our sales and marketing expense as we attempt to exploit the regulatory approvals to market Ameluz® in the United States for the photodynamic therapy treatment of actinic keratoses of mild-to-moderate severity on the face and scalp. There can be no assurance that our sales and marketing efforts will generate sufficient sales to allow us to become profitable. Moreover, because of the numerous risks and uncertainties associated with commercializing pharmaceutical products, we are unable to predict the extent of any future losses or when we will become profitable, if ever.

 

We cannot rule out the possibility that we may engage in additional equity or debt financing in the future, which could dilute the voting rights of stockholders and the value of their shares. If we are unable to achieve profitability over time or to obtain additional equity or debt financing in such a scenario, this would have a material adverse effect on our financial condition.

 

If we fail to obtain additional financing, we may be unable to complete the commercialization of Xepi® and other products we may license.

 

Our operations have consumed substantial amounts of cash since inception. Going forward, we expect that we will require significant funds in order to commercialize the drug Xepi®, the rights to which we acquired in March 2019 through our purchase of Cutanea Life Sciences, Inc., or Cutanea, and the subsequent merger of Biofrontera and Cutanea.

 

On March 31, 2021, we entered into the Second Intercompany Revolving Loan Agreement with Biofrontera AG for $20.0 million committed sources of funds for a two-year term. We believe with the funds available under the Second Intercompany Revolving Loan Agreement, we will have sufficient funds to support the operating, investing, and financing activities of the Company through at least twelve months from the date of the issuance of this prospectus. However, changing circumstances may cause us to consume capital significantly faster than currently anticipated, and we may need to spend more money than currently expected because of circumstances beyond our control. Our future funding requirements, both near- and long-term, will depend on many factors, including, but not limited to:

 

  the effects of competing technological and market developments;
  the cost and timing of completion of commercial-scale manufacturing activities;
  the cost of establishing sales, marketing and distribution capabilities for Ameluz® photodynamic therapy or other products or potential products in the United States; and
  the impact of COVID-19 on our licensor’s clinical trials, the timing of regulatory approvals obtained by our Licensors, demand for our licensed products, our ability to market and sell our licensed products and other matters.

 

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We cannot be certain that additional funding will be available to us on acceptable terms, or at all. If we are unable to raise additional capital in sufficient amounts and on terms acceptable to us, we may have to significantly delay, scale back or discontinue the commercialization of our licensed products or development of product candidates. We also could be required to license our rights to our licensed products and product candidates to third parties on unfavorable terms. In addition, any equity financing would likely result in dilution to holders of our shares, and any debt financing would likely involve significant cash payment obligations and include restrictive covenants that may restrict our ability to operate our business.

 

Any of the above events could prevent us from realizing business opportunities or prevent us from growing our business or responding to competitive pressures, which could have a material adverse effect on our business, prospects, financial condition and/or results of operations and could cause the price of our shares to decline.

 

Our existing and any future indebtedness could adversely affect our ability to operate our business.

 

Under the Share Purchase and Transfer Agreement dated March 25, 2019 (as amended, the “Share Purchase Agreement”), by and among Biofrontera Newderm LLC, Biofrontera AG, Maruho Co., Ltd. and Cutanea, pursuant to which Biofrontera Newderm Inc. LLC, a wholly owned subsidiary of Biofrontera Inc., acquired Cutanea from Maruho Co., Ltd., we are required to repay to Maruho Co., Ltd., $3.6 million on December 31, 2022 and $3.7 million on December 31, 2023 in start-up costs that Maruho Co., Ltd. agreed to pay to Biofrontera Inc., in connection with such acquisition (not to exceed $7.3 million in the aggregate).

 

Our indebtedness could have significant adverse consequences, including:

 

  requiring us to dedicate a portion of our cash to the payment of interest and principal, reducing money available for working capital, capital expenditure, product development and other general corporate purposes;
  increasing our vulnerability to adverse changes in general economic, industry and market conditions;
  increasing the risk of dilution to the holders of our shares in the event any of these bonds are exercised for or converted into our ordinary shares;
  limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete, including changes arising as a result of the COVID-19 pandemic; and
  placing us at a competitive disadvantage to competitors that are better capitalized than we are.

 

We may not have sufficient funds and may be unable to arrange for additional financing to pay the amounts due under our existing debt obligation to Maruho Co. Ltd. under the terms of the Share Purchase and Transfer Agreement pursuant to which Biofrontera AG acquired Cutanea, and which must be repaid if certain profits from the sale of Cutanea products Biofrontera AG agreed to share with Maruho are less than the amount of such start-up costs.

 

We may also engage in debt financing in the future. Failure to make payments or comply with covenants under such debt could result in an event of default and acceleration of amounts due. If an event of default occurs and the lender or lenders accelerate the amounts due, we may not be able to make accelerated payments, and such lenders could file suit against us to collect the amounts due under such obligations or pursue other remedies. In addition, the covenants under such debt obligations could limit our ability to obtain additional debt financing. If we are unable to satisfy such debt obligations it could have material adverse effect on our business, prospects, financial condition and/or results of operations.

 

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Risks Related to Being a Public Company

 

We have identified a material weakness in our internal control over financial reporting, resulting from a control deficiency related to the oversight of third-party service providers. 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 controls, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect our business and stock price.

 

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, 2019 and December 31, 2020, we identified a material weakness in our internal controls over financial reporting. The material weakness we identified 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 a third-party service provider was not sufficiently precise to identify an error. Specifically, as part of the valuation of an intangible asset in connection with the Cutanea acquisition we failed to identify a computational error within the valuation model for the Xepi® intangible asset.

 

While we have taken steps to enhance our internal control environment and continue to address the underlying cause of the material weakness by the creation of additional controls including those designed to strengthen our review and validation of the work product from third-party service providers, the steps we have taken to date, and that we are continuing to implement, may not be sufficient to remediate this material weakness or to avoid the identification of material weaknesses in the future. We will monitor the effectiveness of our remediation plan and will make changes we determine to be appropriate.

 

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 controls, 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.

 

We will incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to compliance with our public company responsibilities and corporate governance practices.

 

As a public company, and particularly after we are no longer an “emerging growth company,” we will incur significant legal, accounting and other expenses that we did not incur as a private company. The Sarbanes-Oxley Act of 2002, or the Sarbanes Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of The Nasdaq Capital Market, or Nasdaq, and other applicable securities rules and regulations impose various requirements on public companies. Our management and other personnel will need to devote a substantial amount of time to compliance with these requirements. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly. If, notwithstanding our efforts to comply with new or changing laws, regulations and standards, we fail to comply, regulatory authorities may initiate legal proceedings against us, and our business may be harmed. Further, failure to comply with these laws, regulations and standards may make it more difficult and more expensive for us to obtain directors’ and officers’ liability insurance, which could make it more difficult for us to attract and retain qualified members to serve on our board of directors or committees or as members of senior management. We cannot predict or estimate the amount of additional costs we will incur as a public company or the timing of such costs.

 

As a result of becoming a public company, we will be obligated to develop and maintain proper and effective internal controls over financial reporting and any failure to maintain the adequacy of these internal controls may adversely affect investor confidence in our company and, as a result, the value of our common shares.

 

We will be required, pursuant to Section 404 of the Sarbanes Oxley Act, or Section 404, to furnish a report by management on, among other things, the effectiveness of our internal controls over financial reporting for the fiscal year ending December 31, 2022. This assessment will need to include disclosure of any material weaknesses identified by our management in our internal controls over financial reporting. Our independent registered public accounting firm will not be required to attest to the effectiveness of our internal controls over financial reporting until our first annual report required to be filed with the SEC following the date we are no longer an emerging growth company, as defined in the JOBS Act. At such time as we are required to obtain auditor attestation, if we then have a material weakness, we would receive an adverse opinion regarding our internal control over financial reporting from our independent registered public accounting firm. We will be required to disclose significant changes made in our internal controls procedures on a quarterly basis.

 

We have already begun the process of compiling the system and processing documentation necessary to perform the evaluation needed to comply with Section 404, and anticipate we will be able to complete our evaluation, testing and any required remediation in a timely fashion. Our compliance with Section 404 will require that we incur additional legal, accounting and other compliance expense and expend significant management efforts. We currently do not have an internal audit group, and although we have accounting and finance staff with appropriate public company experience and technical accounting knowledge, we may need to hire additional consultants or staff to perform the evaluation needed to comply with Section 404.

 

During the evaluation and testing process of our internal controls, if we identify one or more material weaknesses in our internal controls over financial reporting, we will be unable to assert that our internal controls over financial reporting are effective. For example, in connection with the audits of our financial statements as of and for the years ended December 31, 2019 and 2020, we identified a material weakness in our internal control over financial reporting. See “—We have identified a material weakness in our internal control over financial reporting, resulting from a control deficiency related to the oversight of third-party service providers. If we are unable to remediate these this material weakness, or if we identify additional material weaknesses in the future or otherwise fail to maintain an effective system of internal controls, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect our business and stock price.

 

We cannot assure you that the measures we have taken to date, and are continuing to implement, will be sufficient to avoid additional material weaknesses or significant deficiencies in our internal controls over financial reporting in the future. Any failure to maintain effective internal controls over financial reporting could severely inhibit our ability to accurately report our financial condition or results of operations. If we are unable to conclude that our internal controls over financial reporting is effective, or if our independent registered public accounting firm determines we have a material weakness or significant deficiency in our internal controls over financial reporting, we could lose investor confidence in the accuracy and completeness of our financial reports, the market price of our common shares could decline, and we could be subject to sanctions or investigations by Nasdaq, the SEC or other regulatory authorities. Failure to remedy any material weakness in our internal controls over financial reporting, or to implement or maintain other effective control systems required of public companies, could also negatively impact our ability to access to the capital markets.

 

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In addition, effective disclosure controls and procedures enable us to make timely and accurate disclosure of financial and non-financial information that we are required to disclose. As a public company, if our disclosure controls and procedures are ineffective, we may be unable to report our financial results or make other disclosures accurately on a timely basis, which could cause our reported financial results or other disclosures to be materially misstated and result in the loss of investor confidence and cause the market price of our common shares to decline.

 

We are an emerging growth company and a smaller reporting company and we cannot be certain if the reduced disclosure requirements applicable to emerging growth companies or smaller reporting companies will make our common stock less attractive to investors.

 

We are an “emerging growth company” as defined in the JOBS Act. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards until such time as those standards apply to private companies. We have elected to use this exemption from new or revised accounting standards and, therefore, we will not be subject to the same new or revised accounting standards as other public companies that have not made this election.

 

For as long as we continue to be an emerging growth company, we also intend to take advantage of certain other exemptions from various reporting requirements that are applicable to other public companies including, but not limited to, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a non-binding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. We cannot predict if investors will find our common stock less attractive because we will rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.

 

We will remain an emerging growth company until the earliest of (i) the last day of the fiscal year in which we have total annual gross revenue of $1.07 billion or more; (ii) the last day of the fiscal year following the fifth anniversary of the date of the closing of this offering; (iii) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three fiscal years; or (iv) the date on which we are deemed to be a “large accelerated filer” under the rules of the SEC.

 

Additionally, we are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K. Even after we no longer qualify as an emerging growth company, we may still qualify as a “smaller reporting company,” which would allow us to continue to take advantage of many of the same exemptions from disclosure requirements, including presenting only the two most recent fiscal years of audited financial statements and reduced disclosure obligations regarding executive compensation in this prospectus and our periodic reports and proxy statements. We will remain a smaller reporting company until the last day of the fiscal year in which (1) the market value of our shares of Common Stock held by non-affiliates exceeds $250 million as of the prior the end of our second fiscal quarter ending December 31st of each year, or (2) our annual revenues exceeded $100 million during such completed fiscal year and the market value of our ordinary shares held by non-affiliates exceeds $700 million as of the prior to the end of our second fiscal quarter ending December 31st of each year. To the extent we take advantage of such reduced disclosure obligations, it may also make comparison of our financial statements with other public companies difficult or impossible.

 

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Risks Related to This Offering and Ownership of Our Common Stock

 

Biofrontera AG will beneficially own    % of our stock after the completion of the initial public offering and will be able to exert significant control over matters subject to stockholder approval, and its interests may conflict with ours or yours in the future

 

We are currently a wholly-owned subsidiary of Biofrontera AG and, upon the completion of this offering, Biofrontera AG will beneficially own in the aggregate approximately                % of our outstanding voting stock and will continue to exert significant influence on the company. As a result, these stockholders have the ability to significantly influence us through this ownership position. These stockholders may be able to determine all matters requiring stockholder approval. For example, these stockholders may be able to control elections of directors, amendments of our organizational documents, our financing and dividend policy and approval of any merger, sale of assets or other major corporate transaction. This may prevent or discourage unsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest as one of our stockholders.

 

Moreover, because of the significant ownership position held by Biofrontera AG, new investors may not be able to effect a change in the Company’s business or management, and therefore, stockholders would be subject to decisions made by management and Biofrontera AG.

 

Biofrontera AG’s interests may differ from our interests and the interests of our stockholders, and therefore actions Biofrontera AG takes with respect to us, as a significant shareholder, including under the Ameluz LSA, may not be favorable to us or our public stockholders. For a discussion of the risks related to our license agreement with Biofrontera AG, see “Risks Related to the License and Supply Agreements and Our Licensed Products.”

 

We expect that, immediately after this offering, we will be a “controlled company” within the meaning of Nasdaq listing standards, and as a controlled company we will qualify for exemptions from certain corporate governance requirements. We will have the opportunity to elect any of the exemptions afforded a controlled company.

 

We expect that immediately after this offering Biofrontera AG will control more than a majority of the total voting power of our common stock, and as a result we will be a “controlled company” within the meaning of Nasdaq listing standards. Under Nasdaq rules, a company of which more than 50% of the voting power is held by another person or group of persons acting together is a “controlled company” and may elect not to comply with the following Nasdaq rules regarding corporate governance:

 

  the requirement that a majority of our board of directors consist of independent directors;
  the requirement to have a nominating/corporate governance committee composed entirely of independent directors and a written charter addressing the committee’s purpose and responsibilities;
  the requirement to have a compensation committee composed entirely of independent directors and a written charter addressing the committee’s purpose and responsibilities; and
  the requirement of an annual performance evaluation of the nominating/corporate governance and compensation committees.

 

Following the consummation of this initial public offering, two of our four directors will be independent directors, and we will have an independent nominating and corporate governance committee and an independent compensation committee. However, for as long as the “controlled company” exemption is available, our board of directors in the future may not consist of a majority of independent directors and may not have an independent nominating and corporate governance committee or compensation committee. As a result, you may not have the same protections afforded to stockholders of companies that are subject to all of the Nasdaq rules regarding corporate governance.

 

If Biofrontera AG sells a controlling interest in our company to a third party in a private transaction, you may not realize any change-of-control premium on shares of our common stock and we may become subject to the control of a presently unknown third party.

 

The ability of Biofrontera AG to privately sell its shares of our common stock, with no requirement for a concurrent offer to be made to acquire all of the shares of our common stock held by our other stockholders, could prevent you from realizing any change-of-control premium on your shares of our common stock that may otherwise accrue to Biofrontera AG on its private sale of our common stock. Additionally, if Biofrontera AG privately sells its controlling equity interest in our company, we may become subject to the control of a presently unknown third party. Such third party may have conflicts of interest with those of other stockholders. In addition, if Biofrontera AG sells a controlling interest in our company to a third party, our indebtedness may be subject to acceleration, and our other commercial agreements and relationships, including any remaining agreements with Biofrontera AG, could be impacted, all of which may adversely affect our ability to run our business as described herein and may have a material adverse effect on our business, financial condition and results of operations.

 

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If you purchase shares of our common stock in this offering, you will incur immediate and substantial dilution.

 

The offering price of our common stock is substantially higher than the net tangible book value per share of our common stock, which on a pro forma basis was $             per share of our common stock as of March 31, 2021. Based on the assumed initial public offering price of $             per share, which is the midpoint of the price range set forth on the cover page of this prospectus, you will experience immediate dilution of $               per share, representing the difference between our pro forma net tangible book value per share after giving effect to this offering and the assumed initial public offering price. This means that you will pay a higher price per share than the amount of our total tangible assets, less our total liabilities, divided by the number of shares of common stock outstanding. Furthermore, you may experience additional dilution if options or other rights to purchase our common stock that are outstanding or that we may issue in the future are exercised or converted or we issue additional shares of our common stock at prices lower than our net tangible book value at such time. See “Dilution.”

 

No public market for our common stock currently exists, and an active trading market may not develop or be sustained following this offering.

 

Prior to this offering, there has been no public market for our common stock. Although we have applied to have our common stock listed on Nasdaq, an active trading market may not develop following the closing of this offering or, if developed, may not be sustained. The lack of an active market may impair your ability to sell your shares at the time you wish to sell them or at a price that you consider reasonable. The lack of an active market may also reduce the fair market value of your shares. An inactive market may also impair our ability to raise capital to continue to fund operations by selling shares and may impair our ability to acquire other companies or technologies by using our shares as consideration. The initial public offering price was determined by negotiations between us and the underwriters and may not be indicative of the future prices of our common stock.

 

Our share price may be volatile, and you may be unable to sell your shares at or above the offering price.

 

The market price of our common stock is likely to be volatile and could be subject to wide fluctuations in response to many risk factors listed in this section, and others beyond our control, including:

 

  the success of existing or new competitive products or technologies;
  regulatory actions with respect to Ameluz® or Xepi® or our competitors’ products;
  actual or anticipated fluctuations in our financial condition and operating results, including fluctuations in our quarterly and annual results;
  announcements of innovations by us, our Licensors or our competitors;
  overall conditions in our industry and the markets in which we operate;
  market conditions or trends in the biotechnology industry or in the economy as a whole;
  addition or loss of significant healthcare providers or other developments with respect to significant healthcare providers;
  changes in laws or regulations applicable to Ameluz® or Xepi®;
  actual or anticipated changes in our growth rate relative to our competitors;
  announcements by us, our Licensors or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments;
  additions or departures of key personnel;
  issuance of new or updated research or reports by securities analysts;
  fluctuations in the valuation of companies perceived by investors to be comparable to us;
  disputes or other developments related to the patents covering our licensed products, and our Licensors’ ability to obtain intellectual property protection for our products;
  security breaches;
  litigation matters;
  announcement or expectation of additional financing efforts;
  sales of our common stock by us or our stockholders;

 

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  share price and volume fluctuations attributable to inconsistent trading volume levels of our shares;
  the expiration of contractual lock-up agreements with our executive officers, directors and stockholders; and
  general economic and market conditions.

 

Furthermore, the stock markets have experienced price and volume fluctuations that have affected and continue to affect the market prices of equity securities of many companies. These fluctuations often have been unrelated or disproportionate to the operating performance of those companies. These broad market and industry fluctuations, as well as general economic, political and market conditions such as recessions, interest rate changes or international currency fluctuations, may negatively affect the market price of our common stock. If the market price of our common stock after this offering does not exceed the initial public offering price, you may not realize any return on your investment in us and may lose some or all of your investment. In the past, companies that have experienced volatility in the market price of their stock have been subject to securities litigation. This risk is especially relevant for biopharmaceutical companies, which have experienced significant stock price volatility in recent years. We may be the target of this type of litigation in the future. Securities litigation against us could result in substantial costs and divert our management’s attention from other business concerns, which could seriously harm our business.

 

Future sales of our common stock in the public market could cause our share price to fall.

 

Sales of a substantial number of shares of our common stock in the public market after this offering, or the perception that these sales might occur, could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional equity securities. Based on                    shares of common stock outstanding as of               , 2021, upon the closing of this offering, we will have               shares of common stock outstanding.

 

All of the common stock sold in this offering will be freely tradable without restrictions or further registration under the Securities Act of 1933, as amended, or the Securities Act, except for any shares held by our affiliates as defined in Rule 144 under the Securities Act. The remaining shares of common stock outstanding after this offering will be restricted as a result of securities laws, lock-up agreements or other contractual restrictions that restrict transfers for at least days after the date of this prospectus, subject to certain extensions. See also the section of this prospectus captioned “Shares Eligible For Future Sale.”

 

Our management has broad discretion in the use of the net proceeds from this offering and may not use the net proceeds effectively.

 

Our management will have broad discretion in the application of the net proceeds of this offering. We cannot specify with certainty the uses to which we will apply these net proceeds. The failure by our management to apply these funds effectively could adversely affect our ability to continue maintaining and expanding our business.

 

If securities or industry analysts do not publish research or publish unfavorable research about our business, our stock price and trading volume could decline.

 

The trading market for our common stock will be influenced by the research and reports that industry or securities analysts publish about us or our business. If one or more of these analysts ceases coverage of our company or fails to publish reports on us regularly, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline. Moreover, if our operating results do not meet the expectations of the investor community, one or more of the analysts who cover our company may change their recommendations regarding our company, and our stock price could decline.

 

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Our quarterly operating results may fluctuate significantly.

 

We expect our operating results to be subject to quarterly fluctuations. Our net loss and other operating results will be affected by numerous factors, including:

 

  variations in the level of expenses related to our marketing efforts;
  any litigation, including intellectual property infringement lawsuits related to our licensed products, in which we may become involved;
  regulatory developments affecting Ameluz® or Xepi®;
  our execution of any licensing or similar arrangements, and the timing of payments we may make or receive under these arrangements;
  the timing of milestone payments under our existing license agreements; and
  the level of underlying demand for Ameluz® and Xepi® and customers’ buying patterns.

 

If our quarterly operating results fall below the expectations of investors or securities analysts, the price of our common stock could decline substantially. Furthermore, any quarterly fluctuations in our operating results may, in turn, cause the price of our stock to fluctuate substantially.

 

Future sales and issuances of our common stock or rights to purchase our common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause the stock price of our common stock to decline.

 

We may issue additional securities following the closing of this offering. In the future, we may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time. We also expect to issue common stock to employees, consultants and directors pursuant to our equity incentive plans. If we sell common stock, convertible securities or other equity securities in subsequent transactions, or common stock is issued pursuant to equity incentive plans, investors may be materially diluted. New investors in such subsequent transactions could gain rights, preferences and privileges senior to those of holders of our common stock.

 

We have never paid dividends on our common stock and we do not intend to pay dividends for the foreseeable future. Consequently, any gains from an investment in our common stock will likely depend on whether the price of our common stock increases.

 

We have never declared or paid any dividends on our common stock and do not intend to pay any dividends in the foreseeable future. We anticipate that we will retain all of our future earnings for use in the operation of our business and for general corporate purposes. Any determination to pay dividends in the future will be at the discretion of our board of directors. Accordingly, investors must rely on sales of their common stock after price appreciation, which may never occur, as the only way to realize any future gains on their investments. For more information, see the section of this prospectus captioned “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources.”

 

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Our charter documents and Delaware law could prevent a takeover that stockholders consider favorable and could also reduce the market price of our stock.

 

Our amended and restated certificate of incorporation and our amended and restated bylaws will contain provisions that could delay or prevent a change in control of our company. These provisions could also make it more difficult for stockholders to elect directors and take other corporate actions.

 

These provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors, which is responsible for appointing the members of our management.

 

In addition, we are subject to the anti-takeover provisions contained in Section 203 of the Delaware General Corporation Law, or the DGCL. Under Section 203 of the DGCL, a corporation may not, in general, engage in a business combination with any holder of 15% or more of its capital stock unless the holder has held the stock for three years or, among other exceptions, the board of directors has approved the transaction.

 

These and other provisions in our amended and restated certificate of incorporation and our amended and restated bylaws and under Delaware law could discourage potential takeover attempts, reduce the price investors might be willing to pay in the future for shares of our common stock and result in the market price of our common stock being lower than it would be without these provisions. For more information, see the section of this prospectus captioned “Description of Capital Stock—Anti-Takeover Provisions.

 

Our amended and restated certificate of incorporation that will become effective immediately prior to the closing of this offering provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.

 

Our amended and restated certificate of incorporation that will become effective immediately prior to the closing of this offering provides that the Court of Chancery of the State of Delaware is, to the fullest extent permitted by applicable law, the exclusive forum for:

 

  any derivative action or proceeding brought on our behalf;
  any action asserting a claim of breach of a fiduciary duty owed by, or other wrongdoing by, any of our current or former directors, officers, employees or our stockholders;
  any action asserting a claim against us arising under the DGCL, our amended and restated certificate of incorporation, or our amended and restated bylaws (as either may be amended from time to time) or as to which the DGCL confers jurisdiction on the Court of Chancery of the State of Delaware; and
  any action asserting a claim against us that is governed by the internal-affairs doctrine.

 

However, Section 27 of the Exchange Act creates exclusive federal jurisdiction over all claims brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder. Consequently, the exclusive forum provisions will not apply to suits brought to enforce any liability or duty created by the Exchange Act or to any claim for which the federal courts have exclusive jurisdiction.

 

Moreover, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all claims brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. We note that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. Our amended and restated certificate of incorporation will further provide that, unless we consent in writing to the selection of an alternative forum, the federal district courts are the sole and exclusive forum for the resolution of any complaint asserting a right under the Securities Act. The Supreme Court of the State of Delaware has held that such provisions are facially valid under Delaware law. While there can be no assurance that federal or state courts will follow the holding of the Delaware Supreme Court or determine that the provision should be enforced in a particular case, application of the provision means that suits brought by our stockholders to enforce any duty or liability created by the Securities Act must be brought in federal court and cannot be brought in state court.

 

By becoming a stockholder in our Company, you will be deemed to have notice of and have consented to the provisions of our amended and restated certificate of incorporation related to choice of forum. This exclusive forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers, or other employees, which may discourage lawsuits against us and our directors, officers and other employees and result in increased costs for investors to bring a claim. If a court were to find the exclusive forum provision in our amended and restated certificate of incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving the dispute in other jurisdictions, which could seriously harm our business.

 

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Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.

 

Our amended and restated certificate of incorporation and amended and restated bylaws provide that we will indemnify our directors and officers, in each case to the fullest extent permitted by Delaware law.

 

In addition, as permitted by Section 145 of the DGCL, our amended and restated bylaws and our indemnification agreements that we have entered into with our directors and officers provide that:

 

we will indemnify our directors and officers for serving us in those capacities or for serving other business enterprises at our request, to the fullest extent permitted by Delaware law. Delaware law provides that a corporation may indemnify such person if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the registrant and, with respect to any criminal proceeding, had no reasonable cause to believe such person’s conduct was unlawful;
  we may, in our discretion, indemnify employees and agents in those circumstances where indemnification is permitted by applicable law;
  we are required to advance expenses, as incurred, to our directors and officers in connection with defending a proceeding, except that such directors or officers shall undertake to repay such advances if it is ultimately determined that such person is not entitled to indemnification;
  we will not be obligated pursuant to our amended and restated bylaws to indemnify a person with respect to proceedings initiated by that person against us or our other indemnitees, except with respect to proceedings authorized by our board of directors or brought to enforce a right to indemnification;
  the rights conferred in our amended and restated bylaws are not exclusive, and we are authorized to enter into indemnification agreements with our directors, officers, employees and agents and to obtain insurance to indemnify such persons; and
  we may not retroactively amend our amended and restated bylaw provisions to reduce our indemnification obligations to directors, officers, employees and agents.

 

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This prospectus includes forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this prospectus regarding our strategy, future operations, regulatory process, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. The words “believe”, “anticipate”, “intend”, “expect”, “target”, “goal”, “estimate”, “plan”, “assume”, “may”, “will”, “predict”, “project”, “would”, “could” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

 

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. We have based these forward-looking statements on our current expectations and projections about future events, nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. Factors that could cause such differences include, but are not limited to:

 

  our ability to achieve and sustain profitability;
  our ability to compete effectively in selling our products;
  our ability to expand, manage and maintain our direct sales and marketing organizations;
  our actual financial results may vary significantly from forecasts and from period to period;
  our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing;
  our ability to market, commercialize, achieve market acceptance for and sell our products and product candidates;
  market risks regarding consolidation in the healthcare industry;
  the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing from third-party payors for procedures using our products significantly declines;
  the ability of our Licensors to adequately protect the intellectual property related to our licensed products and operate their business without infringing upon the intellectual property rights of others;
  the fact that product quality issues or product defects may harm our business;
  any product liability claims;
  our expectations regarding the merits and outcomes of pending or threatened litigation, including the lawsuit brought by DUSA against us before the District Court of Massachusetts claiming patent infringement, trade secret misappropriation, tortious interference with contractual relations, and deceptive and unfair trade practices; and
  the outbreak and impacts of the novel coronavirus, or COVID-19, on the global economy and our business.

 

Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make.

 

You should read this prospectus and the documents that we reference in this prospectus and have filed with the Securities and Exchange Commission, or SEC, as exhibits to the registration statement of which this prospectus is a part with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

 

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USE OF PROCEEDS

 

We estimate, based upon an assumed initial public offering price of $              per share (which is the midpoint of the price range set forth on the cover page of this prospectus), that we will receive net proceeds from this offering of approximately $              million, or approximately $                if the underwriters exercise their over-allotment option in full, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

 

The principal purposes of this offering are to obtain additional capital to fund our operations, create a public market for our common stock and facilitate our future access to the public equity markets.

 

We currently estimate that we will use the net proceeds from this offering for general corporate purposes, including working capital and continued investments in our growth strategies described in “BusinessOur Strategy.”

 

Specific use of proceeds is estimated as follows:

 

  approximately $45 million to complete expansion of our commercial infrastructure and general working capital which will include hiring of additional personnel, capital expenditures and the costs of operating as a public company.
  the remainder to fund other general corporate purposes, including to pursue our strategy to in-license further products or product opportunities, procure products through asset acquisition from other healthcare companies, as well as acquiring some or all of the shares of other healthcare companies, potentially also including shares of our current parent company, Biofrontera AG, although we have no agreements or commitments for any specific acquisitions or in-licenses as of the date of this prospectus. See “BusinessOur Strategy” for descriptions of our growth strategies.

 

Our expected use of proceeds from this offering represents our current intentions based on our present plans and business condition. As of the date of this prospectus, we cannot predict with certainty all of the particular uses for the proceeds to be received upon the completion of this offering. We may use a portion of the proceeds to pursue selective strategic investment and acquisition opportunities to expand and support our business growth. Although we have no specific agreements, commitments, or understandings with respect to any such activity or acquisition, we evaluate these opportunities and engage in related discussions with other companies from time to time.

 

The amounts and timing of our actual expenditures will depend on numerous factors, such as the status of our sales and marketing efforts, the timing and success of any future clinical trials and preclinical studies, as well as subsequent regulatory submissions for our licensed products, each overseen by the Licensors, the feasibility of any acquisitions or other investments, the amounts of proceeds actually raised in this offering and the amount of cash generated by our operations. Because we operate in a very dynamic and highly competitive industry, the actual use of proceeds may differ substantially from the ranges indicated above. Our management will have broad discretion to allocate the net proceeds from this offering.

 

Pending the use of the net proceeds from this offering, we may invest them in short-term and medium-term interest-bearing instruments.

 

Each $1.00 increase (decrease) in the assumed initial public offering price of $               per share (which is the midpoint of the price range set forth on the cover page of this prospectus) would increase (decrease) the net proceeds to us from this offering by approximately $           million, assuming the number of shares offered, as set forth on the cover page of this prospectus, remains the same, and after deducting estimated offering expenses payable by us.

 

Each 1,000,000 share increase (decrease) in the number of shares offered in this offering would increase (decrease) the net proceeds to us from this offering by approximately $              million, assuming that the price per share for the offering remains at $               (which is the midpoint of the price range set forth on the cover page of this prospectus), and after deducting the estimated offering expenses payable by us.

 

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CAPITALIZATION

 

The following table sets forth the cash and capitalization as of March 31, 2021, as follows:

 

  on an actual basis;
   
  on an as adjusted basis to reflect the issuance and sale by us of               shares of common stock in this offering at an assumed initial public offering price of $               per share (which is the midpoint of the range set forth on the cover page of this prospectus), after deducting the estimated offering expenses payable by us.

 

The as adjusted information below is illustrative only, and our capitalization following the completion of this offering will be adjusted based on the actual initial public offering price and other terms of this offering determined at pricing. You should read this information in conjunction with our financial statements and the related notes included elsewhere in this prospectus and the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section and other financial information contained in this prospectus.

 

   As of March 31, 2021 
   Actual   As adjusted 

(in thousands, except share data)

        
Cash and cash equivalents  $4,637     
           
Equity          
Common stock, par value $0.001 per share; 300,000,000 shares authorized, 8,000,000 shares issued and outstanding, actual;          shares authorized,          shares issued and outstanding, as adjusted   8      
Additional paid-in capital   46,986      
Accumulated deficit   (44,700)     
           
Total stockholders’ equity  $2,294      
           
Total capitalization  $

2,294

      

  

Each $1.00 increase or decrease in the assumed initial public offering price of $             per share (which is the midpoint of the price range set forth on the cover page of this prospectus) would increase or decrease each of cash and cash equivalents, total stockholders’ equity and total capitalization on an as adjusted basis by approximately $                 million, assuming the number of shares offered, as set forth on the cover page of this prospectus, remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

 

Each 1,000,000 share increase or decrease in the number of shares offered in this offering would increase or decrease each of cash and cash equivalents, total stockholders’ equity and total capitalization on an as adjusted basis by approximately $            million, assuming that the price per share for the offering remains at $                (which is the midpoint of the price range set forth on the cover page of this prospectus), and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

 

The information in the table above excludes:

 

                  shares of our common stock available for future issuance under our 2021 Omnibus Incentive Plan.

 

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DIVIDEND POLICY

 

We have never declared or paid cash dividends on our capital stock. We currently intend to retain all available funds and future earnings, if any, to fund the development and expansion of our business, and we do not anticipate paying any cash dividends in the foreseeable future. Any future determination regarding the declaration and payment of dividends will be at the discretion of our board of directors and will depend on then-existing conditions, including our financial condition, operating results, contractual restrictions, capital requirements, business prospects and other factors our board of directors may deem relevant.

 

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DILUTION

 

If you invest in our common stock in this offering, your ownership interest will be immediately diluted to the extent of the difference between the initial public offering price per share and the pro forma as adjusted net tangible book value per share of our common stock after this offering.

 

Our historical net tangible book value (deficit) as of                    , 2021 was $               million, or $             per share of our common stock. Our historical net tangible book value (deficit) is the amount of our total tangible assets less our total liabilities and preferred stock, which is not included within stockholders’ equity (deficit). Historical net tangible book value (deficit) per share represents historical net tangible book value (deficit) divided by the                       shares of our common stock outstanding as of                     , 2021.

 

After giving further effect to our issuance and sale of                  shares of our common stock in this offering at an assumed initial public offering price of $               per share (which is the midpoint of the price range set forth on the cover page of this prospectus) and after deducting estimated offering expenses payable by us, our pro forma as adjusted net tangible book value as of                , 2021, would have been $              million, or $                 per share of common stock. This amount represents an immediate increase in pro forma as adjusted net tangible book value of $               per share to our existing stockholders and an immediate dilution in pro forma as adjusted net tangible book value of $        per share to new investors purchasing shares of common stock in this offering. We determine dilution by subtracting the pro forma as adjusted net tangible book value per share after this offering from the amount of cash that a new investor paid for a share of common stock. The following table illustrates this dilution:

 

Assumed initial public offering price per share of common stock      $ 
Historical net tangible book value (deficit) per share as of            , 2021  $      
Increase per share attributable to the conversion of outstanding preferred stock and payment of accrued dividend          
Pro forma net tangible book value per share as of            , 2021 before this offering          
Increase in pro forma as adjusted net tangible book value per share attributable to investors in this offering          
           
Pro forma as adjusted net tangible book value per share after this offering          
           
Dilution per share to new common stock investors in this offering       $ 

 

If the underwriters exercise their over-allotment option in full, the pro forma as adjusted net tangible book value of our common stock would be $        per share, and the dilution in pro forma as adjusted net tangible book value would be $        per share to new investors purchasing shares of common stock in this offering.

 

A $1.00 increase (decrease) in the assumed initial public offering price of $          per share (which is the midpoint of the price range listed on the cover page of this prospectus) would increase (decrease) the pro forma as adjusted net tangible book value per share after this offering by approximately $           , and dilution in pro forma as adjusted net tangible book value per share to new investors by approximately $            , assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated offering expenses payable by us.

 

The following table summarizes, as of              , 2021, after giving effect to this offering, the number of shares of our common stock purchased from us, the total consideration paid, or to be paid, to us and the average price per share paid, or to be paid, by existing stockholders and by the new investors. The calculation below is based on an assumed initial public offering price of $               per share (which is the midpoint of the price range listed on the cover page of this prospectus) before deducting the estimated offering expenses payable by us.

 

   Shares Purchased   Total Consideration   Average price 
   Number   Percent   Amount   Percent   per share 
Existing stockholders       %  $    %  $ 
                          
New investors          %           %     
                          
Total        100%  $    100%  $ 

  

Each $1.00 increase (decrease) in the assumed initial public offering price of $           per share would increase (decrease) the total consideration paid by new investors and the total consideration paid by all stockholders by $            million, assuming the number of shares offered by us remains the same and after deducting estimated underwriting discounts and commissions but before estimated offering expenses.

 

Except as otherwise indicated, the above discussion and tables assume no exercise of the underwriters’ over-allotment option. If the underwriters exercise their over-allotment option in full, our existing stockholders would own        % and our new investors would own         % of the total number of shares of our common stock outstanding upon the completion of this offering.

 

The number of shares of common stock to be outstanding after the completion of this offering excludes:

 

                  shares of our common stock available for future issuance under our new equity compensation plans

 

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and related notes appearing at the end of this prospectus. Some of the information contained in this discussion and analysis or set forth elsewhere in this prospectus, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk factors” section of this prospectus, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

 

Overview

 

We are a U.S.-based biopharmaceutical company specializing in the commercialization 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 licensed products focus on the treatment of actinic keratoses, which are skin lesions that can sometimes lead to skin cancer. We also market a topical antibiotic for treatment of impetigo, a bacterial skin infection.

 

Our principal product is Ameluz®, which is a prescription drug approved for use in combination with our licensor’s FDA approved medical device, the BF-RhodoLED® lamp, for PDT in the United States for the lesion-directed and field-directed treatment of actinic keratosis of mild-to-moderate severity on the face and scalp. We are currently selling Ameluz® for this indication in the U.S. under the Ameluz LSA. See “Business—Commercial Partners and Agreements—Biofrontera Pharma and Biofrontera Bioscience” in this prospectus for more information. Under the Ameluz LSA, we hold the exclusive license to sell Ameluz® and the BF-RhodoLED® lamp for all indications currently approved by the FDA as well as all future FDA-approved indications. As further described below, under the Ameluz LSA, further extensions of the approved indications for Ameluz® photodynamic therapy in the United States are anticipated.

 

Our second prescription drug 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 adults and children 2 months and older. We are currently selling Xepi® for this indication in the U.S. under the Xepi LSA that was acquired by us on March 25, 2019 through our acquisition of Cutanea Life Sciences, Inc. See “BusinessCommercial Partners and Agreements—Ferrer” in this prospectus for more information.

 

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

 

  expanding our sales in the United States of Ameluz® in combination with the BF-RhodoLED® lamp for the treatment of minimally to moderately thick actinic keratosis of the face and scalp and positioning Ameluz® to be a leading photodynamic therapy product 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 product; and

 

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  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 the Licensors.

 

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; and
     
  procuring products through share acquisition of some or all shares of other healthcare companies, which includes the potential acquisition of shares of our current parent company, Biofrontera AG. 

 

See “Business—Our strategy” section in this prospectus for further details.

 

We devote a substantial portion of our cash resources to the commercialization of our licensed products, Ameluz®, the BF-RhodoLED® lamp and Xepi®. We have financed our operating and capital expenditures through cash proceeds generated from our product sales and proceeds received in connection with the Intercompany Revolving Loan Agreement with Biofrontera AG. On December 31, 2020, the outstanding principal balance on the intercompany loan was converted into shares of common stock.

 

We believe that important measures of our results of operations include product revenue, operating income/(loss) and adjusted EBITDA (a non-GAAP measure as defined below). Our sole source of revenue is sales of products that we license from other companies. Our long-term financial objectives include consistent revenue growth and expanding operating margins. Accordingly, we are focused on 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, COVID-19 has become a global pandemic. As a result of the measures implemented by governments around the world, Biofrontera’s business operations have been directly affected. In particular, there has been a significant decline in demand for Biofrontera’s products worldwide 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. 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, practice closures. After negligible sales of our products in April 2020, we observed a slow recovery of our business again in the summer and later the first signs of stabilization in line with the usual seasonality. Doctors’ offices reopened during the second half of 2020, at least in part, and patients showed increasing willingness to undergo treatment for actinic keratosis. In the fourth quarter of 2020, we again saw a seasonally strong increase in sales. Revenue from product sales for the twelve months of 2020 have declined by about $7.3 million, or 28.0%, when compared to the same period in 2019. Revenue from product sales was $4.7 million for the three months ended March 31, 2021, as compared to $4.6 million for the three months ended March 31, 2020, indicating our revenue is recovering from the global COVID-19 pandemic. January and February revenues were still pre-pandemic in 2020 and substantially lower in 2021, while revenues recovered quickly since March 2021. In order to mitigate the risk from COVID-19, we have taken expedited measures to reduce operating expenses and preserve cash, including headcount reduction, mandatory furlough, freezing hiring and discretionary spend, and voluntary salary reductions from the senior leadership. During the COVID-19 pandemic, we have focused our sales strategy in the U.S. market on our flagship product Ameluz® and delayed the targeted re-launch to improve the positioning of our licensed product Xepi®. To a minor extent, inventories were written down as of December 31, 2020 due to an anticipated expiration of shelf life. As the impact of the COVID-19 pandemic continues, we may experience disruptions that could severely impact our business, operations, and sales and marketing. We continue to monitor trends related to COVID-19 and their impact on our business, results of operations and financial condition.

 

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Cutanea Life Sciences, Inc. Transactions

 

On March 25, 2019, we entered into an agreement with Maruho Co, Ltd. (as amended, the “Share Purchase Agreement”) to acquire 100% of the shares of Cutanea Life Sciences, Inc., including its subsidiaries Dermark LLC and Dermapex LLC through our wholly owned subsidiary Biofrontera Newderm LLC, newly founded on March 21, 2019. As of 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 sole shareholder. Further, a pre-existing collaboration and partnership agreement exists between Maruho Co. Ltd. and Biofrontera AG to examine various branded generic drugs in Europe. Under the terms of the agreement, Maruho paid for all the research and development costs incurred, any new intellectual property developed will be jointly owned by both Maruho and Biofrontera AG, and any pre-existing intellectual property retains its respective ownership. The business combination was not determined to have effectively settled the collaborative agreement and no components of the agreement were determined to be attributable to the business combination in accordance with the provisions of ASC 805, Business Combinations.

 

The acquisition of Cutanea Life Sciences, Inc. has enabled us to market Xepi®, an FDA-approved drug that had already been introduced in the US market. Prior to the acquisition, Cutanea had been marketing Aktipak®, a prescription gel for the treatment of acne, as well as Xepi®, a prescription cream for the treatment of impetigo, since November 2018. Due to technical difficulties in the manufacturing process of Aktipak®, sales of the drug were discontinued in summer 2019. Any assets related to Aktipak® were determined to have no value in purchase accounting due to the fact that the issues with Aktipak®’s manufacture were knowable as of the acquisition date.

 

We acquired Cutanea for an initial purchase price of one US dollar. Pursuant to the 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 purchase agreement will be shared equally between Maruho and Biofrontera until 2030 (“contingent consideration”).

 

Pursuant to the acquisition agreement, Maruho agreed to pay all liabilities relating to or resulting from the pre-contractual period in excess of cash on hand as of acquisition date (“net liability adjustment”). The net liability adjustment is akin to a working capital adjustment, as such, is accounted for as an increase to the cash balance acquired.

 

After the date of acquisition, we are entitled to restructure the business of Cutanea. A post-closing integration committee (the “PCI Committee”), consisting of four members, including two representatives from Maruho and two representatives from Biofrontera Inc., was established to provide oversight in determining the restructuring plan and budget for such restructuring costs. The PCI Committee determines the estimated restructuring costs and Maruho ultimately pays for actual restructuring costs incurred as agreed upon by the PCI Committee. Maruho also indemnifies Biofrontera and Cutanea against all liabilities relating to or resulting from the pre-contractual period. In addition, for the first three months subsequent to the closing date of the acquisition (“working capital period”), Maruho agreed to fund any operating expenses to the extent the actual cash balance is less than the monthly cash target balance (“working capital period operating costs”). The PCI Committee determines the final working capital period operating costs to be paid by Maruho. These restructuring costs and working capital period operating costs Maruho agreed to pay are collectively referred to as “SPA Costs” under the arrangement. SPA costs reimbursed by Maruho are accounted for as other income in the period the amounts were determined in accordance with ASC 810.

 

We also completed a restructuring of the legal entities affiliated with Cutanea on December 31, 2019. At the time of the acquisition, Cutanea owned two wholly owned subsidiaries, Dermapex, LLC and Dermarc, LLC, each of which were Delaware limited liability companies that became indirect wholly owned subsidiaries of Biofrontera as a result of our acquisition of Cutanea through Biofrontera Newderm LLC. The restructuring was completed in the following order: (i) each of Dermapex, LLC and Demarc, LLC were merged with and into Cutanea, with Cutanea surviving, (ii) Cutanea was then merged with and into Newderm, with Newderm surviving, and (iii) Newderm was merged with and into Biofrontera Inc., with Biofrontera Inc. surviving. As a result, Dermapex, LLC, Dermarc, LLC, Cutanea and Newderm were each merged out of existence and all of the assets and liabilities of each of the foregoing were transferred by operation of law to Biofrontera Inc.

 

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In connection with the Cutanea acquisition, we incurred significant transaction costs, primarily diligence-related costs and professional fees. We accounted for the Cutanea acquisition using the acquisition method of accounting in accordance with provisions of ASC 805, Business Combinations, which requires, among other things, that most assets acquired and liabilities assumed be recognized at their estimated fair values as of the acquisition date. Transaction costs were expensed as incurred. The amount by which the fair value of the net assets acquired exceeded the fair value of consideration transferred was recorded as a bargain purchase gain.

 

In connection with this acquisition, we recorded: (i) a $4.6 million intangible asset related to the Xepi® license, (ii) a $1.7 million contract asset related to the benefit associated with the non-interest bearing start-up cost financing, (iii) $6.5 million of contingent consideration related to the estimated profits from the sale of Cutanea products to be shared equally with Maruho, (iv) a bargain purchase gain of $5.7 million due to the excess fair value of the net assets acquired over the cash consideration transferred, as well as (v) a favorable lease asset of $69,000 related to the leased properties. The total fair value of the consideration expected to be transferred from the Company to Maruho was the one US dollar purchase price and $6.5 million of contingent consideration related to the earn-out.

 

When it became apparent there was a potential for a bargain purchase gain, we reviewed the Cutanea assets acquired and liabilities assumed as well as the assumptions utilized in estimating their fair values. Upon completion of this reassessment, we concluded that recording a bargain purchase gain was appropriate and required under accounting principles generally accepted in the United States of America. We believe the seller was motivated to complete the transaction due to the fact that Cutanea had a history of operating losses, Maruho had invested significant amounts and no longer wanted to financially support the business of Cutanea. Further, the transaction was not subject to competitive bidding and with our complementary products, existing U.S. infrastructure, and industry expertise, we expect we can generate profits and returns faster and less expensive than other market participants could and, as such, were an attractive business partner.

 

The fair value of contingent consideration is re-measured at each reporting date. The change in fair value of the contingent consideration in the amount of a $1.0 million increase and $0.1 million increase during the years ended December 31, 2019 and 2020 and in the amount of a $0.3 million decrease and $0.5 million increase during the three months ended March 31, 2020 and 2021 was recorded in operating expenses in the statements of operations.

 

Because Cutanea Life Sciences, Inc. was not merged with us until April 2019 and due to the above factors, our results of operations for the year ended December 31, 2020 are not directly comparable to our results of operations for the year ended December 31, 2019.

 

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Components of Our Results of Operations

 

Revenue, net

 

We generate revenue primarily through the sales of our licensed products Ameluz®, BF-RhodoLED® lamps and Xepi® covered by our exclusive LSAs with our licensors Biofrontera Pharma, Biofrontera Bioscience and Ferrer as described in the section “BusinessCommercial Partners and Agreements.” 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 BF-RhodoLED® lamp and Xepi® are relatively insignificant compared with revenues generated through our sales of Ameluz®. We also generate insignificant related party revenue in connection with an agreement with Biofrontera Bioscience GmbH to provide lamps and associated services. 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.

 

Cost of Revenues, Related Party

 

Cost of revenues, related party, is comprised of purchase costs of our licensed products, Ameluz® and BF-RhodoLED® lamps from Biofrontera Pharma GmbH.

 

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. Cost of revenues excludes the amortization and impairments of intangible asset.

 

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 intangible asset. In connection with the acquisition of Cutanea Life Sciences, Inc., we recorded an intangible asset related to the Xepi® license, which is being amortized on a straight-line basis over an estimated useful life of 11 years.

 

Selling, General and Administrative Expenses, Related Party

 

Selling, general and administrative expenses, related party, primarily relate to the services provided by our sole shareholder, Biofrontera AG, for accounting consolidation, IT support, and pharmacovigilance. These expenses are charged to us based on costs incurred plus 6% in accordance with the Intercompany Services Agreement with Biofrontera AG dated January 1, 2016.

 

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Restructuring Costs

 

We restructured the business of Cutanea and incurred restructuring costs, which were subsequently reimbursed by Maruho. Restructuring costs primarily relate to Aktipak® discontinuation, personnel costs related to the termination all Cutanea employees, and the winding down of Cutanea’s operations.

 

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 is re-measured at each report date until the contingency is resolved.

 

Interest Expense, net

 

Interest expense, net, primarily consists of interest expense incurred under our Revolving Loan Agreement with Biofrontera AG, amortization of the contract asset related to the start-up cost financing from Maruho under the Cutanea acquisition purchase agreement, and immaterial amounts of interest income earned on our financing of purchases of BF-RhodoLED® lamps.

 

Bargain Purchase Gain

 

Bargain purchase gain on the Cutanea acquisition includes the difference between the fair value of the net assets acquired and the amount of consideration transferred.

 

Other Income, net

 

Other income, net primarily includes (i) reimbursed SPA costs, (ii) loss on disposal on Cutanea fixed assets in 2019, (iii) a one-time employee retention credit, or ERC, that we were granted under the CARES Act in 2020, (iv) gain (loss) on foreign currency transactions, and (v) gain on termination of operating leases.

 

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.

 

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Results of Operations

 

Comparison of the Years Ended December 31, 2019 and December 31, 2020

 

The following table summarizes our results of operations for the years ended December 31, 2019 and December 31, 2020:

 

    For the Year Ended December 31,  
(in thousands)   2019     2020     Change  
                   
Product revenues, net   $ 26,131     $ 18,787     $ (7,344 )
Related party revenues     50       62       12  
Revenues, net     26,181     $ 18,849       (7,332 )
                         
Operating expenses:                        
Cost of revenues, related party     11,330       8,313       (3,017 )
Cost of revenues, other     1,078       753       (325 )
Selling, general and administrative     28,041       17,706       (10,335 )
Selling, general and administrative, related party     654       411       (243 )
Restructuring costs     3,531       1,132       (2,399 )
Change in fair value of contingent consideration     962       140       (822 )
Total operating expenses     45,596       28,455       (17,141 )
Loss from operations     (19,415 )     (9,606 )     9,809  
Interest expense, net     (2,134 )     (2,869 )     (735 )
Bargain purchase gain     5,710       -       (10,768 )
Other income, net     4,890       1,552       (3,338)  
Loss before income taxes     (10,949 )     (10,923 )     26  
Income tax expenses     33       64       31  
Net loss   $ (10,982 )   $ (10,987 )   $ (5 )

 

Revenue, net

 

Net revenue was $26.2 million and $18.8 million for 2019 and 2020, respectively, a decrease of $7.3 million, or 28.0%. The decrease was primarily driven by: (i) lower volume of Ameluz orders, which resulted in a decrease in Ameluz revenue of $7.4 million, partially offset by a price increase, which increased Ameluz revenue by $0.6 million, and (ii) lower volume of Xepi® orders, which was partially offset by a decrease in co-pay and rebate expense, resulting in a net decrease in Xepi® revenue of $0.3 million. The decreases in sales order volume were mostly due to COVID-19, which resulted in a significant decline in demand for Biofrontera’s licensed products when different priorities for medical treatments emerged and caused a delay of actinic keratosis treatment for most patients. In addition, 2019 net revenue includes $0.3 million Aktipak® sales. Due to technical difficulties in the manufacturing process of Aktipak®, we indefinitely discontinued sales of Aktipak® in summer 2019.

 

Operating Expenses

 

Cost of Revenues, Related Party

 

Cost of revenues, related party was $11.3 million and $8.3 million for 2019 and 2020, respectively, a decrease of $3.0 million, or 26.6%. The decrease was primarily driven by the decrease in Ameluz sales volume which resulted in a $2.0 million decrease in cost of revenues, related party, and the cost reimbursement received from Biofrontera Pharma GmbH in 2020 which resulted in $1.0 million decrease in cost of revenue, related party.

 

Cost of Revenues, Other

 

Cost of revenues, other was $1.1 million and $0.8 million for 2019 and 2020, respectively, a decrease of $0.3 million, or 30.2%. The decrease was primarily driven by (i) Aktipak direct cost of $0.5 million incurred in 2019 only, and (ii) 0.2 million decrease in third-party logistics and distribution costs driven by lower volume of product sales, offset by a $0.4 million provision for Xepi® inventory obsolescence due to product expiring in 2020.

 

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Selling, General and Administrative Expenses

 

Selling, general and administrative expenses were $28.0 million and $17.7 million for 2019 and 2020, respectively, a decrease of $10.3 million, or 36.9%. The decrease was primarily driven by (i) temporary actions taken in response to the COVID-19 pandemic contributing to $9.5 million decrease in selling, general and administrative expenses, (ii) cost reimbursement received from Biofrontera Pharma GmbH which resulted in a $0.4 million cost reduction, (iii) $0.3 million one-time legal fee incurred in 2019, and (iv) $0.2 million decrease in depreciation expense due to disposal of Cutanea fixed assets in 2019. The overall decrease was partially offset by an increase in amortization expense of intangible asset. Amortization expense of the Xepi® license intangible asset acquired in connection with the Cutanea acquisition increased by $0.1 million from $0.3 million in 2019 to $0.4 million in 2020 due to partial year amortization expense recorded in 2019 as compared to a full year of amortization expense in 2020.

 

Selling, General and Administrative Expenses, Related Party

 

Selling, general and administrative expenses, related party were $0.7 million and $0.4 million for 2019 and 2020, respectively, a decrease of $0.2 million. Related party expense is based on costs incurred by Biofrontera AG plus 6% for services provided to us related to accounting consolidation, IT support and pharmacovigilance.

 

Restructuring Costs

 

Restructuring costs were $3.5 million and $1.1 million for 2019 and 2020, respectively, a decrease of 2.4 million, or 67.9%. A large portion of restructuring costs incurred in 2019 related to Aktipak® discontinuation and personnel costs related to the termination all Cutanea employees. These activities were substantially completed by the end of 2019.

 

Change in Fair Value of Contingent Consideration

 

Change in fair value of contingent consideration was an increase of $1.0 million and an increase of $0.1 million for 2019 and 2020, respectively. Change in fair value of contingent consideration is driven by our estimated profit share the Company is required to pay under the contingent consideration arrangement.

 

Interest Expense, net

 

Interest expense primarily consists of the interest incurred at a rate of 6% per annum on the intercompany loan issued by Biofrontera AG as well as the straight-line amortization of the contract asset related to start-up cost financing received from Maruho under the Cutanea acquisition purchase agreement. Interest expense was $2.1 million and $2.9 million for 2019 and 2020, respectively. The increase in interest expense was mainly driven by additional borrowings during 2020. The outstanding principal balance on the intercompany loan was converted into shares of common stock in December 2020.

 

Bargain Purchase Gain

 

Bargain purchase gain on the Cutanea acquisition in the amount of $5.7 million in 2019 represents the difference between the fair value of the net assets acquired and the amount of consideration transferred.

 

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Other Income, net

 

Other income, net was $4.9 million and $1.6 million in 2019 and 2020, respectively, a decrease of $3.3 million. A significant portion of this decrease was driven by $5.3 million of reimbursed SPA costs during 2019 as compared to $1.2 million of reimbursed SPA costs in 2020. The decrease was partially offset by a one-time loss of $0.6 million recognized on write-off of Cutanea fixed assets during 2019 and a one-time income of $0.3 million related to employee retention tax credit during 2020.

 

Comparison of the Three Months Ended March 31, 2020 and 2021

 

The following table summarizes our results of operations for the three months ended March 31, 2020 and 2021:

 

   Three Months Ended March 31, 
(in thousands)  2020   2021   Change 
             
Product revenues, net  $4,608   $4,731   $123 
Related party revenues   15    13    (2)
Revenues, net   4,623   $4,744    121 
                
Operating expenses:               
Cost of revenues, related party   2,268    2,408    140 
Cost of revenues, other   119    163    44 
Selling, general and administrative   5,884    4,758    (1,126)
Selling, general and administrative, related party   99    164    65 
Restructuring costs   312    281    (31)
Change in fair value of contingent consideration   (262)   498    760 
Total operating expenses   8,420    8,272    (148)
Loss from operations   (3,797)   (3,528)   269 
Interest expense, net   (660)   (84)   576 
Other income, net   354    79    (275)
Loss before income taxes   (4,103)   (3,533)   570 
Income tax expenses   1    1    - 
Net loss  $(4,104)  $(3,534)  $570 

 

Revenue, net

 

Net revenue was $4.6 million and $4.7 million for the three months ended March 31, 2020 and 2021, respectively, an increase of $0.1 million, or 2.6%. The increase was primarily driven by an Ameluz® price increase, which resulted in an Ameluz® revenue increase of $0.2 million. The increase was partially offset by the lower volume of Ameluz® orders, which decreased revenue by $0.1 million.

 

Operating Expenses

 

Cost of Revenues, Related Party

 

Cost of revenues, related party was $2.3 million and $2.4 million for the three months ended March 31, 2020 and 2021, respectively, an increase of $0.1 million, or 6.2%. The increase was primarily driven by the increase in Ameluz product revenue. Cost of Ameluz is directly correlated to the selling price under the Ameluz LSA with Biofrontera Pharma GmbH.

 

Cost of Revenues, Other

 

Cost of revenues, other was $0.1 million and $0.2 million for the three months ended March 31, 2020 and 2021, respectively. Cost of revenues, other incurred during these periods included purchase costs of our licensed product, Xepi®, sales based Xepi® royalties, and third-party logistics and distribution costs.

 

Selling, General and Administrative Expenses

 

Selling, general and administrative expenses were $5.9 million and $4.8 million for the three months ended March 31, 2020 and 2021, respectively, a decrease of $1.1 million, or 19.1%. The decrease was primarily driven by the continued actions taken in response to the COVID-19 pandemic that resulted in delays in sales and marketing spend with $0.7 million in temporary cost savings, $0.2 million of reduced headcount costs and $0.2 million of reduced general operating expenses.

 

Selling, General and Administrative Expenses, Related Party

 

Selling, general and administrative expenses, related party were $0.1 million and $0.2 million for the three months ended March 31, 2020 and 2021, respectively. Related party expense is based on costs incurred by Biofrontera AG plus 6% for services provided to us related to accounting consolidation, IT support and pharmacovigilance.

 

Restructuring Costs

 

Restructuring costs were $0.3 million and $0.3 million for the three months ended March 31, 2020 and 2021 respectively, both of which related to facility exit costs.

 

Change in Fair Value of Contingent Consideration

 

Change in fair value of contingent consideration was a decrease of $0.3 million and an increase of $0.5 million for the three months ended March 31, 2020 and 2021, respectively. Change in fair value of contingent consideration is driven by our estimated profit share the Company is required to pay under the contingent consideration arrangement.

 

Interest Expense, net

 

Interest expense was $0.7 million and $0.1 million for the three months ended March 31, 2020 and 2021, respectively. Interest expense during the three months ended March 31, 2020 included $0.6 million interest incurred on the intercompany loan issued by Biofrontera AG. The intercompany loan was fully converted into common stock at the end of 2020. In addition, 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 of these periods.

 

Other Income, net

 

Other income, net was $0.4 million and $0.1 million for the three months ended March 31, 2020 and 2021, respectively, both of which primarily related to the reimbursed SPA costs.

 

Net Income to Adjusted EBITDA Reconciliation for years ended December 31, 2019 and 2020 and three months ended March 31, 2020 and 2021

 

We define adjusted EBITDA as net income or loss from our statements of operations before interest income and expense, income taxes, depreciation and amortization, and other non-operating items from our 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. 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 GAAP as measures of operating performance or cash flows as measures of 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 GAAP.

 

Bargain purchase gain on Cutanea acquisition: We exclude the impact of the bargain purchase gain on Cutanea acquisition. The bargain purchase gain on Cutanea acquisition reflects the difference between the fair value of the net assets acquired and the amount of consideration transferred, which is non-cash. The bargain purchase gain on Cutanea acquisition represents gains that arise outside the ordinary course of our operations. Therefore, we believe that the exclusion of the bargain purchase gain allows for meaningful analysis of operating results.

 

Change in fair value of contingent consideration: Pursuant to the Cutanea acquisition agreement, the profits from the sale of Cutanea products will be shared equally between Maruho and Biofrontera until 2030 (“contingent consideration”). The fair value of the contingent consideration is determined to be $6.5 million on the acquisition date and is re-measured at each reporting date. We exclude the impact of the change in fair value of contingent consideration as this is non-cash.

 

Cost reimbursement from Biofrontera Pharma GmbH: On August 27, 2020, we received $1.5 million cash consideration from Biofrontera Pharma GmbH to support our marketing effort to grow the sales of our licensed products we purchase from Biofrontera Pharma GmbH, Ameluz® and BF-RhodoLED® lamps. Of the $1.5 million, $0.4 million was recorded as a reduction to marketing expense and $1.1 million was recorded as a reduction to cost of revenue. This cash consideration is one-time and non-operating in nature. We believe that adjustment for this item more closely correlates with the reality of our operating performance.

 

Loss on disposal of Cutanea fixed assets: We exclude the loss on disposal of Cutanea fixed assets to allow for a more accurate assessment of operations as these assets will not be required to support our future operations and the related loss is non-operating in nature. We believe that the adjustment of this item more closely correlates with the reality of our operating performance.

 

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Non-operating legal expenses: To measure operating performance, we exclude certain legal expenses that arise outside the ordinary course of our operations. Such legal costs primarily relate to the Cutanea acquisition. 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.

 

Employee retention credit: We exclude a one-time ERC that we were granted under the CARES Act, which was recorded as other income. We believe that the exclusion of this item allows for more meaningful analysis of operating results.

 

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-GAAP financial information is viewed with GAAP financial information, investors are provided with a more meaningful understanding of our ongoing operating performance.

 

The below table presents a reconciliation from net loss to Adjusted EBITDA for the years ended December 31, 2019 and 2020 and three months ended March 31, 2020 and 2021:

 

  

Years ended

December 31,

  

Three months ended

March 31,

 
   2019   2020   2020   2021 
Net income/(loss)  $(10,982)  $(10,987)  $(4,104)  $(3,534)
Interest expense, net   2,134    2,869    660    84 
Income tax expenses   33    64    1    1 
Depreciation and amortization   667    562    141    138 
EBITDA   (8,148)   (7,492)   (3,302)   (3,311)
Bargain purchase gain on Cutanea acquisition   (5,710)   -    -    - 
Change in fair value of contingent consideration   962    140    (262)   498 
Cost reimbursement from Biofrontera Pharma GmbH   -    (1,500)   -    - 
Loss on disposal of Cutanea fixed assets   586    -    -    - 
Non-operating legal expense   310    -    -    - 
Employee retention credit (“ERC”)   -    (299)   -    - 
Adjusted EBITDA  $(12,000)  $(9,151)  $(3,564)  $(2,813)
Adjusted EBITDA margin   -45.8%   -48.5%   -77.1%   -59.3%

 

Adjusted EBITDA

 

Adjusted EBITDA improved from ($12.0) million to ($9.2) million during the years ended December 31, 2019 and December 31, 2020. Our adjusted EBITDA margin decreased from (45.8%) for the year ended December 31, 2019 to (48.5%) for the year ended December 31, 2020.

 

Adjusted EBITDA improved from ($3.6) million to ($2.8) million during the three months ended March 31, 2020 and March 31, 2021. Our adjusted EBITDA margin improved from (77.1%) for the three months ended March 31, 2020 to (59.3%) for the three months ended March 31, 2021.

 

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Liquidity and Capital Resources

 

We devote a substantial portion of our cash resources to the commercialization of our licensed products, Ameluz®, the BF-RhodoLED® lamp and Xepi®. We have historically financed our operating and capital expenditures through cash proceeds generated from our product sales and proceeds received in connection with the Intercompany Revolving Loan Agreement with our sole shareholder, Biofrontera AG. On December 31, 2020, the Company agreed to convert the outstanding principal balance of the revolving debt in the amount of $47.0 million into an aggregate of 7,999,000 shares of common stock at a purchase price of $5.875 per share, which was based on our internal assessment and agreement with our sole shareholder, for aggregate gross capital contribution of $47.0 million. Refer to Note 14, Related party transaction to our financial statements included in this prospectus for further details on the Intercompany Revolving Loan Agreement.

 

Since inception, we have incurred losses and generated negative cash flows from operations. As of March 31, 2021, we had an accumulated deficit of $44.7 million and cash and cash equivalents of $4.6 million.

 

Cash Flows

 

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

 

  

For the Year Ended

December 31,

  

Three months ended

March 31,

 
(in thousands)  2019   2020   2020   2021 
Net cash used in operating activities  $(37,677)  $(12,369)  $(6,620)  $(3,443)
Net cash provided by investing activities   25,395    -    -    - 
Net cash provided by financing activities   16,400    13,194    1,300    - 
Net increase in cash and restricted cash  $4,118   $825   $(5,320)  $(3,443)

 

Operating Activities

 

During the year ended December 31, 2019, operating activities used $37.7 million of cash, primarily resulting from our net loss of $11.0 million, adjusted for non-cash items including $5.7 million of bargain purchase gain related to the Cutanea acquisition, and a net decrease in accounts payable and other liabilities of approximately $20.9 million. The net decrease in accounts payable and other liabilities was primarily due to the settlement of $24.3 million of liabilities assumed through the Cutanea acquisition.

 

During the year ended December 31, 2020, operating activities used $12.4 million of cash, primarily resulting from our net loss of $11.0 million, adjusted for non-cash items including depreciation and amortization in the aggregate of $0.6 million, non-cash interest expense of $0.4 million and non-cash expense related to the Xepi® inventory provision in the amount of $0.4 million.

 

During the three months ended March 31, 2020, operating activities used $6.6 million of cash, primarily resulting from our net loss of $4.1 million and net cash used by changes in our operating assets and liabilities of $2.5 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 year ended December 31, 2019, net cash provided by investing activities in the amount of $25.4 million consisted mainly of cash inflows related to the Cutanea acquisition.

 

Financing Activities

 

During the year ended December 31, 2019 and 2020, net cash provided by financing activities was $16.4 million and $13.2 million, respectively. Financing activities during both periods consisted of cash inflows related to the proceeds from related party indebtedness and start-up cost financing related to the Cutanea acquisition.

 

During the three months ended March 31, 2020 and 2021, cash provided by financing activities was $1.3 million and $0, respectively. Cash provided by financing activities in 2020 was related to proceeds from the related party indebtedness.

 

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Funding Requirements

 

We expect to continue to generate revenue from product sales. We also expect to continue to incur operating losses from significant sales and marketing efforts in the U.S as we seek to expand the commercialization of Ameluz®. In addition, we expect to incur additional expenses to add and improve operational, financial and information systems and personnel, including personnel to support our product commercialization efforts. We also expect to incur significant costs to continue to comply with corporate governance, internal controls and similar requirements applicable to us as a public company in the U.S. We do not expect to incur significant costs related to capital expenditures.

 

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®;
     
  the costs of maintaining and extending our regulatory approvals;
     
  the extent to which we acquire or invest in 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 cost to pay back $7.3 million start-up cost financing to Maruho and the costs of profit sharing with Maruho in connection with the Cutanea acquisition.

 

Our growth is dependent on the continued financial support of Biofrontera AG. Failure of our sole shareholder to provide financial support to us, as and when needed, could have a negative impact on our financial condition and ability to pursue our business strategies. On March 31, 2021, we entered into the Second Intercompany Revolving Loan Agreement with Biofrontera AG for $20.0 million committed sources of funds for a two-year term. Refer to Note 22, Subsequent Events, to our financial statements included in this prospectus for further details. With the funds available under the Second Intercompany Revolving Loan Agreement, we will have sufficient funds to support the operating, investing, and financing activities of the Company through at least twelve months from the date of the issuance of this prospectus.

 

Impact of becoming a standalone company

 

We expect that our transition to operating as a standalone company will have a number of potentially significant effects on our results of operations.

 

One-off effects in connection with becoming a standalone company — In the transition to becoming a public company and operating as a standalone entity, we expect to incur certain one-off expenses. These include costs associated with the financial statement reporting requirements of a standalone company, such as the costs associated with preparing U.S. GAAP financial statements.

 

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Additional operating costs for standalone company — In the transition to becoming a public company and operating as a standalone entity, we will incur additional operating expenses that could be significant as a percentage of our net revenues, including costs related to the build out of treasury and investor relations functions, additional non-executive board expenses, shareholder administration and insurance costs. In the short term, we expect general and administrative expenses to increase (both in absolute terms and as a percentage of net revenues) as a result of the costs associated with becoming a public company and operating as a standalone entity.

 

Additional costs to further business development and expansion - As we seek to expand the commercialization of Ameluz® and Xepi®, we expect to incur additional operating costs for significant sales and marketing efforts 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.

 

Critical 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 financial statements, which have been prepared in accordance with generally accepted accounting principles of the United States, or GAAP. The preparation of the financial statements in accordance with 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 revenue recognition, valuation of receivables and inventory, the fair value of assets acquired and liabilities assumed in business combinations, contingent consideration, valuation of intangible and other long-lived assets, product sales allowances and reserves 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.

 

While our significant accounting policies are described in more detail in Note 2, Summary of Significant Accounting Policies, to our financial statements included in this prospectus, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.

 

Business Combination

 

Our financial statements include the operations of acquired businesses after the completion of the acquisitions. We account for acquired businesses using the acquisition method of accounting in accordance with provisions of ASC 805, Business Combinations, which requires, among other things, that most assets acquired and liabilities assumed be recognized at their estimated fair values as of the acquisition date. Transaction costs are expensed as incurred. Goodwill is calculated as the excess of the cost of purchased businesses over the fair value of their underlying net assets acquired. The amount by which the fair value of the net assets acquired exceeds the fair value of consideration transferred is recorded as a bargain purchase gain.

 

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We accounted for the contingent consideration related to the Cutanea acquisition as part of the acquisition cost and recognized such contingent consideration at fair value as of the acquisition date. We considered a number of factors, including information provided by an outside valuation advisor. Contingent consideration from the Cutanea acquisition is reported at the estimated fair values based on probability-adjusted present value of the consideration expected to be paid, using significant inputs and estimates. Key assumptions used in these estimates include probability assessments with respect to the likelihood of achieving certain milestones and discount rates consistent with the level of risk of achievement as further discussed in Note 4, Fair Value Measurements to the financial statements as included in the prospectus. The fair value of the contingent consideration is remeasured each reporting period, with changes in the fair value included in current operations. The remeasured liability amount could be significantly different from the amount at the acquisition date, resulting in material charges or credits in future reporting periods.

 

The Xepi® license intangible asset related to the Cutanea acquisition is included as part of the acquisition cost and recognized at fair value as of the acquisition date using an income approach with assumed discount rates over the applicable term.

 

Fair Value Measurements

 

For discussion about fair value measurements, refer to Note 3, Cutanea Acquisition and Note 4, Fair Value Measurements to the financial statements as included in the prospectus, and “—Business Combination” above.

 

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Revenue recognition

 

We account for revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers. Under ASC Topic 606, revenue is recognized when a customer obtains control of promised goods or services in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services.

 

To determine revenue recognition, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. We only apply the five-step model to contracts when collectability of the consideration to which we are entitled in exchange for the goods or services we transfer to the customer is determined to be probable.

 

We realize revenue primarily through the sale of our licensed products. Sales of Ameluz® are made directly to physicians, hospitals or other qualified healthcare providers. Sales are recognized, net of sales deductions, when ownership and control are transferred to the customer. Sales deductions include expected trade discounts and allowances, product returns, and government rebates. These discounts and allowances are estimated at the time of sale based on the amounts incurred or expected to be received for the related sales.

 

Xepi® is sold directly to specialty pharmacies. Sales are recognized net of sales deductions when ownership and control are transferred to the customer. Sales deductions include expected returns, discounts and incentives such as payments made under patient assistance programs. These rebates are estimated at the time of sale based on the amounts incurred or expected to be received for the related sales.

 

The payment terms for sales of our licensed pharmaceutical products are primarily short-term payment terms with the possibility of volume based discounts and co-pay assistance discounts.

 

The BF-RhodoLED® lamp is also sold directly to physicians, hospitals or other qualified healthcare providers through (i) direct sales or (ii) an evaluation period up to six-month for a fee, after which a customer can decide to purchase or return the lamp. For direct sales, revenue is recognized only after complete installation has taken place. As directed by the instruction manual, the lamp may only be used by the customer once it has been professionally installed. A final decision to purchase the lamps that are within the evaluation period does not need to be made until the end of the evaluation period. Lamps that are not returned at the end of the evaluation period are converted into sales in accordance with the contract terms. We generate revenues from the monthly fees during the evaluation period and from the sale of lamps at the end of the evaluation period.

 

Variable Consideration

 

Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and which result from discounts, rebates and other incentives that are offered within contracts between the Company and its customers relating to the Company’s sales of its licensed products. Components of variable consideration include trade discounts and allowances, product returns, government rebates, and other incentives such as patient co-pay assistance. Variable consideration is recorded on the balance sheet as either a reduction of accounts receivable, if payable to a customer, or as a current liability, if payable to a third party other than a customer. These reserves are based on the amounts earned or expected to be claimed on the related sales. Where appropriate, these estimates take into consideration relevant factors such as our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. These reserves reflect our best estimates of the amount of consideration to which it is entitled based on the terms of the contract. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our estimates, we will adjust these estimates, and record any necessary adjustments in the period such variances become known.

 

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Trade Discounts and Allowances - We provide customers with trade discounts, rebates, allowances and/or other incentives. We record estimates for these items as a reduction of revenue in the same period the revenue is recognized.

 

Government and Payor Rebates - We contract with, or are subject to arrangements with, certain third-party payors, including pharmacy benefit managers and government agencies, for the payment of rebates with respect to utilization of our commercial products. We are also subject to discount and rebate obligations under state and federal Medicaid programs and Medicare. We record estimates for these discounts and rebates as a reduction of revenue in the same period the revenue is recognized.

 

Other Incentives - We maintain a co-pay assistance program which is intended to provide financial assistance to qualified patients with the cost of purchasing Xepi®. We estimate and record accruals for these incentives as a reduction of revenue in the period the revenue is recognized. We estimate amounts for co-pay assistance based upon the number of claims and the cost per claim that we expect to receive associated with products sold to customers but remaining in the distribution channel at the end of each reporting period.

 

Royalties

 

For arrangements that include sales-based royalties, we recognize royalty expense at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Royalty expense is recorded as cost of revenues.

 

Product Warranty

 

We generally provide a 36-month warranty for sales of the BF-RhodoLED® lamp for which estimated contractual warranty obligations are recorded as an expense at the time of installation. Customers do not have the option to purchase the warranty separately and the warranty does not provide the customer with a service beyond the assurance that the BF-RhodoLED® lamp complies with agreed-upon specifications. Therefore, the warranty is not considered to be a performance obligation. The lamps are subject to regulatory and quality standards. Future warranty costs are estimated based on historical product performance rates and related costs to repair given products. The accounting estimate related to product warranty expense involves judgment in determining future estimated warranty costs. Should actual performance rates or repair costs differ from estimates, revisions to the estimated warranty liability would be required. Warranty expense is recorded as selling, general and administrative expenses.

 

Recently issued accounting pronouncements

 

A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our financial statements included in this prospectus.

 

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Contractual Obligations and Commitments

 

Facility Leases and Auto Leases

 

The following table summarizes our contractual obligations as of December 31, 2020 related to facility operating leases and vehicle operating leases, net of facility sublease income, including the effects that such obligations are expected to have on our liquidity and cash flows in future periods:

 

(in thousands)            
Years ending December 31,  Gross future lease commitments  

Sublease

income

  

Net future

lease commitments

 
2021  $1,723   $(323)  $1,400 
2022   709    -    709 
2023   494    -    494 
2024   470    -    470 
2025   352    -    352 
Total  $3,748   $(323)  $3,425 

 

Cutanea earnout payments

 

We are obligated 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 are also obligated to share product profits with Maruho equally from January 1, 2020 through October 30, 2030. Amounts related to product profits sharing with Maruho are not known as of December 31, 2020 or March 31, 2021. Refer to Note 3, Cutanea Acquisition to our financial statements included in this prospectus for further details.

 

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® under the Xepi LSA exceed $25,000,000, and ii) $4,000,000 upon the first occasion when annual net sales of Xepi® under the Xepi LSA exceed $50,000,000. No payments were made in 2019 or 2020 related to Xepi® milestones. As of December 31, 2020 and March 31, 2021, we were unable to estimate the timing or likelihood of achieving these milestones.

 

Off-balance Sheet Arrangements

 

Besides the contractual obligations and commitments as discussed above, 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 a 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.

 

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BUSINESS

 

Overview

 

We are a U.S.-based biopharmaceutical company specializing in the commercialization 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 licensed products focus on the treatment of actinic keratoses, which are skin lesions that can sometimes lead to skin cancer. We also market a topical antibiotic for treatment of impetigo, a bacterial skin infection.

 

Our principal product is Ameluz®, which is a prescription drug approved for use in combination with our licensor’s FDA approved medical device, the BF-RhodoLED® lamp, for PDT in the United States for the lesion-directed and field-directed treatment of actinic keratosis of mild-to-moderate severity on the face and scalp. We are currently selling Ameluz® for this indication in the U.S. under the Ameluz LSA. See “—Commercial Partners and Agreements—Biofrontera Pharma and Biofrontera Bioscience” in this prospectus for more information. Under the Ameluz LSA, we hold the exclusive license to sell Ameluz® and the BF-RhodoLED® lamp for all indications currently approved by the FDA as well as all future FDA-approved indications. As further described below, under the Ameluz LSA, further extensions of the approved indications for Ameluz® photodynamic therapy in the United States are anticipated.

 

Our second prescription drug 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 adults and children 2 months and older. We are currently selling Xepi® for this indication in the U.S. under the Xepi LSA that was acquired by Biofrontera on March 25, 2019 through our acquisition of Cutanea Life Sciences, Inc. See “BusinessCommercial Partners and Agreements—Ferrer” in this prospectus for more information. Acquisition details are described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Key factors affecting our performance—Cutanea Life Sciences, Inc. Transactions” section within this prospectus.

 

As mentioned above, on March 25, 2019, we acquired Cutanea from Maruho Co., Ltd. In November 2018, Cutanea had just launched Xepi®, a prescription cream for the treatment of impetigo. The acquisition of Cutanea Life Sciences, Inc. in March 2019 has enabled us to market an FDA-approved drug that has already been introduced in the U.S. market. We believe that Xepi® has the potential to be another innovative product with a large market potential in our portfolio.

 

As a licensee, we rely on our licensors to conduct clinical trials in order to pursue extensions to the current product indications approved by the FDA. Currently, Biofrontera AG (through its wholly owned subsidiary Biofrontera Bioscience GmbH) is conducting or preparing for the following development pipeline with respect to our flagship licensed product Ameluz® and the BF-RhodoLED® lamp:

 

        Clinical Phase    
Product    Indication / comments   Territory   Pre-clinical   I   II   III   Submission   Status
Ameluz®   AK: Pharmacokinetics study   US                     FDA submission in Q1/2021. In addition to this study, the FDA requires a safety study in order to allow larger treatment fields
RhodoLED® XL   Illumination of larger body regions   US                     FDA submission in Q1/2021 and FDA resubmission in Q2/2021
Ameluz®   Basal cell carcinoma   US                     Phase III ongoing
Ameluz®   Moderate to severe acne   US                       Phase II in preparation
Ameluz®   AK: Face and Scalp with pain-reducing illumination protocol   US                       Phase III in preparation
Ameluz®   AK: Trunk & extremities   US                       Phase III in preparation
Ameluz®   Squamous cell carcinoma in situ   EU/US                       Phase III in preparation

 

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