Filed
Pursuant to Rule 424(b)(3)
Registration
No. 333-265467
9,695,143
Shares of Common Stock Offered by the Selling Stockholder
This
prospectus relates to the offering and resale, from time to time, by the selling stockholder identified herein (the “Selling
Stockholder”) of up to 9,695,143 shares of common stock issued or issuable to the selling stockholder including (i) 1,850,000
shares of our common stock, which were issued by us on May 17, 2022 pursuant to a Securities and Purchase Agreement entered into on May
16, 2022 with a single institutional investor (the “2022 Private Placement”), (ii) 4,988,000 shares of common stock issuable
upon the exercise of outstanding warrants, which were also issued in the 2022 Private Placement and (iii) 2,857,143 shares of common
stock issuable upon the exercise of outstanding warrants, which were issued by us on December 1, 2021 pursuant to a Securities and Purchase
Agreement entered into on November 29, 2021 with the same single institutional investor (the “2021 Private Placement”). Please
see “Private Placement of Shares of Common Stock and Warrants” beginning on page 21 of this prospectus.
We
will not receive any proceeds from the sale of shares of common stock by the selling stockholder. Upon the cash exercise of the warrants
however, if all such warrants are exercised, we will receive the exercise price of such warrants, for an aggregate amount of approximately
$24.5 million.
The
selling stockholder may sell all or a portion of the shares of common stock beneficially owned by it and offered hereby from time to
time directly or through one or more underwriters, broker-dealers or agents. Please see the section entitled “Plan of Distribution”
on page 23 of this prospectus for more information. For information on the selling stockholder, see the section entitled “Selling
Stockholder” on page 22 of this prospectus. We will bear all fees and expenses incident to our obligation to register the shares
of common stock.
Our
common stock is quoted on the Nasdaq Capital Market under the symbol “BFRI.” On June 6, 2022, the last reported sale
price per share of our common stock was $2.51.
The
selling stockholder will offer its shares at prevailing market prices or privately negotiated prices.
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 securities involves a high degree of risk. See “Risk Factors” beginning on page 8 to read about factors you
should consider before buying our securities.
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.
Prospectus
dated June 9, 2022.
TABLE
OF CONTENTS
ABOUT
THIS PROSPECTUS
We
and the Selling Stockholder have not authorized anyone to provide any information or to make any representations other than those contained
in this prospectus. We and the Selling Stockholder 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 and the Selling Stockholder have not done anything that would permit the sale of our common stock
being offered by the Selling Stockholder in any jurisdiction where action for that 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 and the distribution of this prospectus outside the United States.
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”), 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 “Ameluz Licensor” refer collectively to Biofrontera Pharma and Biofrontera Bioscience.
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 2020 and 2021 are references to the years ended December 31, 2020
and 2021. Our most recent fiscal year ended on December 31, 2021.
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.
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 securities. You should read the entire prospectus, including the information
incorporated by reference herein, carefully, including the section titled “Risk Factors,” included elsewhere in this prospectus
and in the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition
and Results of Operations” and our financial statements and the related notes included in our Annual Report on Form 10-K for the
year ended December 31, 2021, or Form 10-K, which is incorporated by reference herein, 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 principal licensed
product focuses 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 licensed product is Ameluz®, which is a prescription drug approved for use in combination with the Ameluz Licensor’s
Food and Drug Administration, or FDA, approved medical device, RhodoLED® lamp series, consisting of the BF-RhdoLED®
and the RhodoLED® XL lamps, for photodynamic therapy, or PDT (when used together, “Ameluz® PDT”)
in the United States for the lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity on the face
and scalp. We are currently selling Ameluz® for this indication in the United States under an exclusive license and supply
agreement, or Ameluz LSA. See “Business—Commercial Partners and Agreements—Biofrontera Pharma
and Biofrontera Bioscience” in our Form 10-K for more information. Under the Ameluz LSA, we hold the exclusive license to sell
Ameluz® and the RhodoLED® lamp series comprising the BF-RhodoLED® and the new, more advanced
RhodoLED® XL in the United States for all indications currently approved by the FDA as well as all future FDA-approved
indications that the Ameluz Licensor may pursue. We have the authority under the Ameluz LSA in certain circumstances to (i) take over
clinical development with respect to the indications the Ameluz Licensor is currently pursuing with the FDA (as well as certain other
clinical studies identified in the Ameluz LSA), ii) take over regulatory work and manufacturing responsibilities from the Ameluz Licensor,
and iii) to offset the costs of such operations by adjusting the transfer price for Ameluz® or to reduce the transfer
price at a fixed ratio. The Ameluz Licensor does not have any obligation under the Ameluz LSA, to perform or finance clinical trials
to promote new indications beyond those the Ameluz Licensor is currently pursuing with the FDA (as well as certain other clinical studies
identified in the Ameluz LSA). Under the Ameluz LSA, further extensions of the approved indications for Ameluz® photodynamic
therapy in the United States are anticipated.
Our
second prescription drug licensed product in our portfolio is Xepi® (ozenoxacin cream, 1%), a topical non-fluorinated
quinolone that inhibits bacterial growth. Currently, no antibiotic resistance against Xepi® is known and it has been specifically
approved by the FDA for the treatment of impetigo, a common skin infection, due to Staphylococcus aureus or Streptococcus pyogenes. It
is approved for use in the United States in adults and children 2 months and older. We are currently selling Xepi® for
this indication in the United States under an exclusive license and supply agreement, as amended, or Xepi LSA, with Ferrer that was assumed
by Biofrontera on March 25, 2019 through our acquisition of Cutanea Life Sciences, Inc.
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 in March 2019 has enabled us to market an FDA-approved drug that has
already been introduced in the U.S. market. Although recent developments with respect to the third-party manufacturer that was providing
our supply of Xepi® have impacted the timing of sales expansion and improved market positioning, we believe that Xepi®
has the potential to be another innovative product with a large market potential in our portfolio. See “Management’s
Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Estimates—Intangible
Assets and Impairment Assessment” in our Form 10-K.
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, the Ameluz Licensor has initiated clinical trials for the following changes in the label and new indications with
respect to our flagship licensed product Ameluz® and the RhodoLED® lamp series. These studies are all being
pursued as part of the Investigational New Drug Application that the Ameluz Licensor submitted to the FDA in 2017 for the development
of Ameluz®/in combination with the BF-RhodoLED® lamp to treat superficial basal cell carcinoma.
| |
|
|
|
|
|
Clinical
Phase |
|
|
|
|
| Product
|
|
Indication
/ comments |
|
Pre-clinical |
|
I |
|
II |
|
III |
|
Approval
process |
|
Status
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Ameluz®
in combination with RhodoLED® XL(1) |
|
Actinic
Keratosis on face & scalp(2) |
|
|
|
● |
|
|
|
|
|
|
|
Safety
study using 3 tubes of Ameluz®; IRB approval obtained; protocol registered with the FDA; patient recruitment started
in December 2021 |
| Ameluz®
in combination with RhodoLED® |
|
Superficial
basal cell carcinoma(3) |
|
|
|
|
|
|
|
● |
|
|
|
Special
protocol assessment by the FDA prior to study start, patient recruitment is ongoing, last patient in expected by end of 2022 |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Ameluz®
in combination with RhodoLED® XL |
|
Moderate
to severe acne |
|
|
|
|
|
● |
|
|
|
|
|
IRB
approval obtained; study protocol registered with FDA in October 2021; patient recruitment started in December 2021 |
| (1) |
BF-RhodoLED®
lamp was approved in 2016. FDA did not request any further clinical trials for RhodoLED®-XL lamp, which was
subsequently approved in October 2021. |
| (2)
|
Phase
II and Phase III trials not anticipated to be required for label change. |
| (3) |
Additional
Phase I and Phase II trials not required, because Ameluz® is an approved drug. |
We
have the authority under the Ameluz LSA with respect to each of the indications described in the table above (as well as certain other
clinical studies identified in the Corrected Amendment to the Ameluz LSA) in certain circumstances to take over clinical development,
regulatory work and manufacturing from the Ameluz Licensor, if they are unable or unwilling to perform these functions appropriately.
The Ameluz Licensor may choose, but has no obligation under the Ameluz LSA, to seek FDA approval with respect to additional indications.
Although we have the exclusive license in the United States to sell any and all indications developed by the Ameluz Licensor (including
indications in the future that are not listed in the Ameluz LSA), the pursuit of any additional indications beyond those identified in
the Ameluz LSA by us, if the Ameluz Licensor declined to pursue such additional indication, would need to be separately negotiated between
us and the Ameluz Licensor.
The
current development pipeline is intended to expand commercialization in the United States of Ameluz®, as a combination
product with the RhodoLED® lamp series, by means of marketing additional indications for our licensed products. The Ameluz
LSA entitles us to an exclusive license in the United States of the products covered under the Ameluz LSA which includes any future indications
for the licensed products that the Biofrontera Group may pursue with the FDA.
We
currently do not have the ability to conduct any clinical trials, nor do we exercise any control over the progress of clinical trials
for our licensed products. Under the Ameluz LSA and the Xepi LSA, our Licensors’ control clinical development for the applicable
licensed product. With respect to each of the FDA applications and clinical studies identified in the Ameluz LSA and under certain circumstances,
for example, if the Ameluz Licensor fails to pursue mutually beneficial clinical development, we may choose to organize and finance trials
and subtract the cost from the transfer price of future shipments.
We
are unaware of any immediate or near-term plans of Ferrer for a U.S.-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 RhodoLED® lamp series 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 licensed 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. |
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, including the possible acquisition of shares
of our former parent company and significant stockholder, Biofrontera AG. |
Company
History and Management Team
We
were formed in March 2015 as Biofrontera Inc., a Delaware corporation, and a wholly owned subsidiary of Biofrontera AG, a company organized
under German law. On November 2, 2021, we consummated our initial public offering of 3,600,000 units (each consisting of (i) one share
of our common stock and (ii) one warrant entitling the holder to purchase one share of our common stock at an exercise price of $5.00
per share) and 540,000 additional warrants not included in the units.
As
of June 6, 2022, Biofrontera AG holds 42.2% of the outstanding shares of our common stock. We entered into an Amended and Restated
Master Contract Services Agreement, or Services Agreement, which provides for the execution of statements of work that will replace the
applicable provisions of our previous intercompany services agreement dated January 1, 2016, or 2016 Services Agreement, by and among
us, Biofrontera AG, Biofrontera Pharma and Biofrontera Bioscience, enabling us to continue to use the Biofrontera Group’s IT resources
as well as providing access to the Biofrontera Group’s resources with respect to quality management, regulatory affairs and medical
affairs. If we deem that the Biofrontera Group should continue to provide these services we will execute a statement of work under the
Services Agreement with respect to such services. We currently have statements of work in place regarding IT, regulatory affairs, medical
affairs, pharmacovigilance and investor relations services, and are continuously assessing the other services historically provided to
us by Biofrontera AG to determine 1) if they are needed and 2) whether they can or should be obtained from other third-party providers.
Our
management team includes Erica Monaco as Chief Executive Officer and Prof. Dr. Hermann Lübbert as Executive Chairman. Day-to-day
operations are overseen by Ms. Monaco as our Chief Executive Officer, and Prof. Dr. Lübbert’s service as Executive Chairman
enables our management team to benefit from his experience.
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 and in our Annual Report on Form 10-K for the year
ended December 31, 2021, which is incorporated by reference herein, 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 is from 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 such 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 the Ameluz Licensor 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
Ameluz Licensor 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 the Ameluz Licensor fails
to maintain its relationships with these manufacturers or if both of these manufacturers are unable to produce product for the Ameluz
Licensor, our business could be materially harmed. |
| |
|
|
| |
● |
If
our Licensors or our Licensors’ manufacturing partners, as applicable, fail to manufacture Ameluz®, 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 has been 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 Ameluz Licensor for our supply of Ameluz® and 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 Ameluz Licensor, Ferrer or additional third
parties for the supply, development and commercialization of future licensed products or product candidates. Although we have the
authority under the Ameluz LSA with respect to the indications that the Ameluz Licensor is currently pursuing with the FDA (as well
as certain other clinical studies identified in the Ameluz LSA) in certain circumstances to take over clinical development, regulatory
work and manufacturing from the Ameluz Licensor if they are unable or unwilling to perform these functions appropriately, the sourcing
and manufacture of our licensed products as well as the regulatory approvals and clinical trials related to our licensed products
are currently controlled, and will likely continue to be controlled for the foreseeable future, by our existing and future collaborators.
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 control deficiencies related
to management’s review of work performed by specialists. If we are unable to remediate this material weakness, of 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. |
| |
|
|
| |
● |
As
of June 6, 2022, Biofrontera AG beneficially owns 42.2% of our outstanding shares of common stock 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. |
| |
|
|
| |
● |
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 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
Corporate Information
We
were incorporated in March 2015 and commenced operations in May 2016. Our first commercial licensed 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 our initial public 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.
The
Offering
| Issuer |
|
Biofrontera
Inc. |
| |
|
|
| Securities
offered by the Selling Stockholder |
|
1,850,000
shares of common stock and 7,845,143 shares of common stock issuable upon the exercise of warrants |
| |
|
|
| Common
stock outstanding |
|
18,954,749
shares as of June 6, 2022 |
| |
|
|
| Common
stock outstanding assuming the exercise of all warrants issued in the 2021 Private Placement and 2022 Private Placement |
|
26,799,892
Shares. |
| |
|
|
| Use
of proceeds |
|
We
will not receive any of the proceeds from the sale of the shares being offered by the Selling
Stockholder. Upon the full exercise of the warrants for an aggregate 7,845,143 shares
of common stock by payment of cash however, we will receive the exercise price of the warrants,
or an aggregate amount of approximately $24.5 million from the Selling Stockholder.
|
| Plan
of distribution |
|
The Selling Stockholder may sell all or a portion of the shares of common stock beneficially owned by it and offered hereby from time to time directly or through one or more underwriters, broker-dealers or agents. Registration of the common stock covered by this prospectus does not mean, however, that such shares necessarily will be offered or sold. See “Plan of Distribution.”
|
| 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 90 days after the completion of this offering without the prior written consent of the underwriters. |
| |
|
|
| Risk
factors |
|
See
“Risk Factors” beginning on page 8 of this prospectus and the other information included or incorporated
by reference in this prospectus for a discussion of factors you should carefully consider before deciding to invest in shares of
our common stock. |
| |
|
|
| Nasdaq
Capital Market symbol for common stock |
|
“BFRI” |
The
number of shares of common stock to be outstanding after this offering is based on 18,954,749 shares of our common stock outstanding
as of June 6, 2022, and assumes the exercise of the warrants into 7,845,143 shares of common stock. The number of shares of common
stock to be outstanding after this offering excludes:
| |
● |
the exercise of warrants to purchase up to 1,492,394
shares of common stock issued in connection with our initial public offering; |
| |
●
|
2,750,000
shares of our common stock available for future issuance under our 2021 Omnibus Incentive Plan; and |
| |
●
|
403,628
shares of our common stock that may be issued upon the full exercise of the Unit Purchase Options issued in connection with our initial
public offering and the 2021 Private Placement. |
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 risks and
uncertainties set forth under the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ended December
31, 2021, which is incorporated by reference herein, as well as the other information in this prospectus and the documents incorporated
by reference herein, including our financial statements and the related notes and the section “Management’s Discussion and
Analysis of Financial Condition and Results of Operations,” included in our Form 10-K, 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.
Risks
Related to This Offering and Ownership of Our Common Stock
As
of June 6, 2022, Biofrontera AG beneficially owns 42.2% of our outstanding shares of common stock 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
As
of June 6, 2022, Biofrontera AG beneficially owns in the aggregate approximately 42.2% of our outstanding voting stock and will
continue to exert significant influence on the company. If all of the outstanding warrants issued in connection with our initial public
offering, the 2021 Private Placement and the 2022 Private Placement were exercised, Biofrontera AG’s beneficial ownership would
be further reduced to 29.9%. However, even if Biofrontera AG’s beneficial ownership was reduced to 29.9% or lower, it would likely
continue to have a significant portion (and perhaps even a majority) of the voting power in a shareholder meeting. As a result, Biofrontera
AG will have the ability to significantly influence us through this ownership position. Biofrontera AG may be able to determine all matters
requiring stockholder approval. For example, Biofrontera AG 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 and our classified board structure, 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 other 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 “Risk Factors—Risks Related
to the License and Supply Agreements and Our Licensed Products” in our Form 10-K.
Furthermore,
Biofrontera AG is a public company with a comparatively low amount of shares that are regularly traded and several shareholders who each
hold a significant stake in Biofrontera AG. Any of these shareholders may exert their influence on Biofrontera AG by voting in favor
of proposals that are in their individual interest or electing members to Biofrontera AG’s supervisory board who could act to align
Biofrontera AG’s actions with the interests of such shareholders. Under German law, company management must obtain the consent
of the supervisory board for certain actions. Since 2017, several legal actions have been filed by one of Biofrontera AG’s significant
shareholders opposing resolutions passed at the shareholders’ meetings, including actions for annulment and rescission of resolutions
related to financing transactions undertaken by Biofrontera AG and they could seek to cause Biofrontera AG to take actions as our significant
shareholder that no longer support our strategy as set forth in this prospectus and may be contrary to the interests of our other stockholders.
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.
Although
Biofrontera AG holds less than the majority of the voting power of our common stock, it may still exert a controlling influence over
us, since many shares of our common stock are held by retail investors who may not vote at shareholder meetings. 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.
Provisions
of our outstanding warrants could discourage an acquisition of us by a third party.
In
addition to the discussion of the provisions of our certificate of incorporation, our bylaws, certain provisions of our outstanding warrants
could make it more difficult or expensive for a third party to acquire us. The warrants prohibit us from engaging in certain transactions
constituting “fundamental transactions” unless, among other things, the surviving entity assumes our obligations under the
warrants. These and other provisions of our outstanding warrants could prevent or deter a third party from acquiring us even where the
acquisition could be beneficial to you.
Our
share price may be volatile, and you may be unable to sell your shares and/or warrants 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®, the BF-RhodoLED® lamp (and its successors) 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®, the BF-RhodoLED® lamp (and its successors) 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 licensed products; |
| |
● |
security
breaches; |
| |
● |
litigation
matters; |
| |
● |
announcement
or expectation of additional financing efforts; |
| |
● |
sales
of our common stock by us or our stockholders; |
| |
● |
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. 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 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 17,104,749 shares of common stock outstanding as of May 12, 2022, upon the closing of the sale of our common stock being offered
by the selling stockholder, we will have 26,799,896 shares of common stock outstanding.
All
of the common stock sold by the selling stockholder will be freely tradable without restrictions or further registration under the Securities
Act.
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.
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.
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 or the Unit Purchase Option, 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 our Form 10-K captioned “Management’s Discussion and Analysis of Financial Condition and
Results of Operations—Liquidity and Capital Resources.”
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 contains 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 Securities and Certificate of Incorporation—Anti-Takeover
Provisions.”
Our
amended and restated certificate of incorporation 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 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.
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. |
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 licensed products; |
| |
● |
changes
in our relationship with our Licensors’ |
| |
● |
Our
Licensors’ ability to manufacture our licensed 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 licensed 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; |
| |
● |
our
ability to market, commercialize, achieve market acceptance for and sell our licensed products; |
| |
● |
the
fact that product quality issues or product defects may harm our business; |
| |
● |
any
product liability claims; |
| |
● |
our
ability to transition to being a public company’ |
| |
● |
the
progress, timing and completion of our Licensors’ research, development and preclinical studies and clinical trials for our
licensed products and our Licensors’ ability to obtain the regulatory approvals necessary for the marketing of our licensed
products in the United States; |
| |
● |
the
impact of extraordinary events, such as the current novel coronavirus (“COVID-19”) pandemic and its evolving nature;
and |
| |
● |
those
risks listed in the sections of our Form 10-K entitled “Risk Factors” and in our other filings with the Securities
and Exchange Commission, or SEC. |
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 incorporate by reference in this prospectus and have filed with the SEC, and the
documents attached 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.
USE
OF PROCEEDS
We
will not receive any of the proceeds from the sale of the shares of our common stock being offered for sale by the Selling Stockholder.
Upon
the exercise of the warrants for an aggregate of 7,845,143 shares of common stock assuming all payments are made in cash and there is
no reliance on cashless exercise provisions, however, we will receive the exercise price of the warrants, or an aggregate amount of approximately
$24.5 million, from the Selling Stockholder. We will bear all fees and expenses incident to our obligation to register the shares of
common stock. Brokerage fees, commissions and similar expenses, if any, attributable to the sale of shares offered hereby will be borne
by the Selling Stockholder.
There
is no assurance the warrants will be exchanged for cash. We intend to use such proceeds, if any, for general corporate purposes,
including working capital.
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.
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The
following table sets forth information with respect to the beneficial ownership of our common stock as of June 6, 2022, for each
person or group know to us who beneficially owns more than 5% of our common stock, each of our directors and director nominees, each
of our named executive officers and all of our directors, director nominees and executive officers as a group.
Beneficial
ownership for the purposes of the following table is determined in accordance with the rules and regulations of the SEC. These rules
generally provide that a person is the beneficial owner of securities if such person has or shares the power to vote or direct the voting
thereof, or to dispose or direct the disposition thereof or has the right to acquire such powers within 60 days. Common stock subject
to options that are currently exercisable or exercisable, and restricted stock units that have vested or will vest, within 60 days of
June 7, 2022 are deemed to be outstanding and beneficially owned by the person holding the options or restricted stock units.
These shares, however, are not deemed outstanding for the purposes of computing the percentage ownership of any other person. Except
as disclosed in the footnotes to this table and subject to applicable community property laws, we believe that each shareholder identified
in the table possesses sole voting and investment power over all common stock shown as beneficially owned by the shareholder.
Unless
otherwise noted below, the address of each person listed on the table is c/o Biofrontera Inc., 120 Presidential Way, Suite 330, Woburn,
Massachusetts 01801.
| Name of beneficial owner | |
Common Stock beneficially owned | | |
% of Common Stock Owned | | |
Options exercisable
and restricted stock units vesting within 60 days(1)(2) | |
| 5% or more stockholders: | |
| | | |
| | | |
| | |
Biofrontera AG
Hemmelrather Weg 201
D-51377
Leverkusen, Germany | |
| 8,000,000 | | |
| 42.2 | | |
| — | |
Armistice Capital Master Fund Ltd. c/o
Armistice Capital, LLC
510 Madison Avenue, 7th Floor
New York, New York
10022(3) | |
| 1,850,000 | | |
| 9.8 | % | |
| — | |
| | |
| | | |
| | | |
| | |
| Named executive officers and directors: | |
| | | |
| | | |
| | |
| Hermann Lübbert | |
| — | | |
| — | | |
| 113,379 | |
| Erica Monaco | |
| — | | |
| — | | |
| 56,689 | |
| John J. Borer | |
| — | | |
| — | | |
| 3,667 | |
| Loretta M. Wedge, CPA, CCGMA | |
| — | | |
| — | | |
| 3,667 | |
| Beth J. Hoffman, Ph.D. | |
| — | | |
| — | | |
| 3,667 | |
| Kevin D. Weber | |
| — | | |
| — | | |
| 3,667 | |
| | |
| | | |
| | | |
| | |
| All current directors and executive officers as a group (6 persons) | |
| — | | |
| — | | |
| 184,736 | |
| (1) |
On
December 9, 2021, Prof. Dr. Lübbert was awarded 113,379 restricted stock units and Ms. Monaco was awarded 56,689 restricted
stock units. All of the restricted stock units will vest on June 9, 2022 and will be settled in shares, cash or a combination thereof
within 60 days of the vesting date. |
| (2) |
On May 18, 2022, Mr. Borer, Ms. Wedge, Ms. Hoffman and
Mr. Weber were each awarded options to purchase up to 22,000 shares of common stock. The options will vest in twelve equal monthly
installments beginning on June 18, 2022 and ending on May 18, 2023, with the result that options to purchase up to 3,667 shares will
have vested and become exercisable within 60 days of the date of this prospectus. |
| (3) |
The
shares of Common Stock reported herein are held by Armistice Capital Master Fund Ltd., a Cayman Islands exempted company (the “Master
Fund”), and may be deemed to be indirectly beneficially owned by (i) Armistice Capital, LLC (“Armistice Capital”),
as the investment manager of the Master Fund; and (ii) Steven Boyd, as the Managing Member of Armistice Capital. Armistice Capital
and Steven Boyd disclaim beneficial ownership of the securities except to the extent of their respective pecuniary interests therein. |
DESCRIPTION
OF SECURITIES AND CERTIFICATE OF INCORPORATION
General
Our
amended and restated certificate of incorporation authorizes capital stock consisting of (i) 300,000,000 shares of common stock, par
value $0.001 per share and (ii) 20,000,000 shares of preferred stock, par value $0.001 per share. No preferred stock has been issued
by us.
The
following summary describes the material provisions of our common stock. We urge you to read our amended and restated certificate of
incorporation and our amended and restated bylaws, which are included as exhibits to the registration statement of which this prospectus
forms a part.
Certain
provisions of our amended and restated certificate of incorporation and our amended and restated bylaws summarized below may be deemed
to have an anti-takeover effect and may delay or prevent a tender offer or takeover attempt that a stockholder might consider in its
best interest, including those attempts that might result in a premium over the market price for the shares of common stock.
Common
Stock
The
holders of our common stock are entitled to one vote for each share held on all matters submitted to a vote of the stockholders. The
holders of our common stock do not have any cumulative voting rights. Holders of our common stock are entitled to receive ratably any
dividends declared by our board of directors out of funds legally available for that purpose, subject to any preferential dividend rights
of any outstanding preferred stock. Our common stock has no preemptive rights, conversion rights or other subscription rights or redemption
or sinking fund provisions.
In
the event of our liquidation, dissolution or winding up, holders of our common stock will be entitled to share ratably in all assets
remaining after payment of all debts and other liabilities and any liquidation preference of any outstanding preferred stock.
Upon
our dissolution or liquidation, after payment in full of all amounts required to be paid to creditors and to the holders of preferred
stock having liquidation preferences, if any, the holders of shares of our common stock will be entitled to receive pro rata our remaining
assets available for distribution for distribution to stockholders after the payment of all of our debts and other liabilities, subject
to the prior rights of any preferred stock then outstanding.
Forum
Selection
Our
amended and restated certificate of incorporation provides that unless we consent in writing to the selection of an alternative forum,
the Court of Chancery of the State of Delaware will, to the fullest extent permitted by applicable law, be the sole and exclusive forum
for: (i) any derivative action or proceeding brought on our behalf; (ii) any action asserting a claim of breach of a fiduciary duty owed
by any of our directors, officers, other employees or stockholders to us or our stockholders; (iii) any action asserting a claim arising
pursuant to any provision of the DGCL, our amended and restated certificate of incorporation or our amended and restated bylaws, or as
to which the DGCL confers exclusive jurisdiction on the Court of Chancery; or (iv) any action asserting a claim governed by the internal
affairs doctrine; provided that 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. Unless the Company consents in writing to the
selection of an alternative forum, the federal district courts of the United States of America shall be the exclusive forum for the resolution
of any complaint asserting a cause of action arising 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. We note that investors cannot waive compliance with the federal
securities laws and the rules and regulations thereunder. Any person or entity purchasing or otherwise acquiring or holding any
interest in shares of our capital stock will be deemed to have notice of and consented to this provision.
Dividends
Declaration
and payment of any dividend will be subject to the discretion of our board of directors. The time and amount of dividends will be dependent
upon our business prospects, results of operations, financial condition, cash requirements and availability, debt repayment obligations,
capital expenditure needs, contractual restrictions, covenants in the agreements governing our current and future indebtedness, industry
trends, the provisions of Delaware law affecting the payment of distributions to stockholders and any other factors our board of directors
may consider relevant. We currently intend to retain all available funds and any future earnings to fund the development and growth of
our business, and therefore do not anticipate declaring or paying any cash dividends on our common stock in the foreseeable future. See
“Dividend Policy” and “Risk Factors—Risks Related to the Offering and Ownership 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.”
Anti-Takeover
Provisions
Our
amended and restated certificate of incorporation and amended and restated bylaws, contain provisions that may delay, defer or discourage
another party from acquiring control of us. We expect that these provisions, which are summarized below, will discourage coercive takeover
practices or inadequate takeover bids. These provisions are also designed to encourage persons seeking to acquire control of us to first
negotiate with our board of directors, which we believe may result in an improvement of the terms of any such acquisition in favor of
our stockholders. However, they also give our board of directors the power to discourage acquisitions that some stockholders may favor.
See “Risk Factors—Risks Related to the Offering and Ownership of Our Common Stock—Our charter documents and Delaware
law could prevent a takeover that stockholders consider favorable and could also reduce the market price of our stock.”
Authorized
but Unissued Shares
The
authorized but unissued shares of our common stock are available for future issuance without stockholder approval, subject to any limitations
imposed by the listing standards of Nasdaq. These additional shares may be used for a variety of corporate finance transactions, acquisitions
and employee benefit plans. The existence of authorized but unissued and unreserved common stock and preferred stock could make more
difficult or discourage an attempt to obtain control of us by means of a proxy contest, tender offer, merger or otherwise.
Stockholder
Action; Special Meeting of Stockholders
Our
amended and restated certificate of incorporation provides that our stockholders will not be able to take action by written consent for
any matter and may only take action at annual or special meetings. As a result, a holder controlling a majority of our capital stock
would not be able to amend our amended and restated bylaws or remove directors without holding a meeting of our stockholders called in
accordance with our amended and restated bylaws, unless previously approved by our board of directors. Our amended and restated certificate
of incorporation will further provide that special meetings of our stockholders may be called only by (i) the president or (ii) the president
or secretary acting upon the written request of a majority of our board of directors, thus limiting the ability of a stockholder to call
a special meeting. These provisions might delay the ability of our stockholders to force consideration of a proposal, including the removal
of directors.
Classified
Board of Directors
Our
board of directors is divided into three classes, Class I, Class II and Class III, with members of each class serving staggered three-year
terms. Our amended and restated certificate of incorporation provides that the authorized number of directors may be changed only by
resolution of the board of directors. Subject to the terms of any preferred stock, any or all of the directors may be removed from office
at any time, but only for cause and only by the affirmative vote of holders of 66-2/3% of the voting power of all then outstanding shares
of our capital stock entitled to vote generally in the election of directors, voting together as a single class.
Advance
Notice Requirements for Stockholder Proposals and Director Nominations
In
addition, our amended and restated bylaws establish an advance notice procedure for stockholder proposals to be brought before an annual
meeting of stockholders, including proposed nominations of candidates for election to our board of directors. In order for any matter
to be “properly brought” before a meeting, a stockholder will have to comply with advance notice and duration of ownership
requirements and provide us with certain information. Stockholders at an annual meeting may only consider proposals or nominations specified
in the notice of meeting or brought before the meeting by or at the direction of our board of directors or by a qualified stockholder
of record on the record date for the meeting, who is entitled to vote at the meeting and who has delivered timely written notice in proper
form to our secretary of the stockholder’s intention to bring such business before the meeting. These provisions could have the
effect of delaying stockholder actions that are favored by the holders of a majority of our outstanding voting securities until the next
stockholder meeting.
Amendment
of Certificate of Incorporation or Bylaws
The
DGCL provides generally that the affirmative vote of the holders of a majority in voting power of the shares entitled to vote is required
to amend a corporation’s certificate of incorporation, unless a corporation’s certificate of incorporation requires a greater
percentage. Our bylaws may be amended or repealed by a majority vote of our board of directors or by the affirmative vote of the holders
a majority of the votes which all our stockholders would be eligible to cast in an election of directors. In addition, the affirmative
vote of the holders of at least 66-2/3% of the votes that all our stockholders would be entitled to cast in any election of directors
is required to amend or repeal or to adopt any provisions inconsistent with any of the provisions of our certificate of incorporation
described above.
Section
203 of the DGCL
We
are subject to Section 203 of the DGCL, which prohibits persons deemed “interested stockholders” from engaging in a “business
combination” with a publicly held Delaware corporation for three years following the date these persons become interested stockholders
unless the business combination is, or the transaction in which the person became an interested stockholder was, approved in a prescribed
manner or another prescribed exception applies. Generally, an “interested stockholder” is a person who, together with affiliates
and associates, owns, or within three years prior to the determination of interested stockholder status did own, 15% or more of a corporation’s
voting stock. Generally, a “business combination” includes a merger, asset or stock sale, or other transaction resulting
in a financial benefit to the interested stockholder. The existence of this provision may have an anti-takeover effect with respect to
transactions not approved in advance by the board of directors, such as discouraging takeover attempts that might result in a premium
over the market price of our common stock.
Limitations
on Liability and Indemnification of Officers and Directors
Our
amended and restated bylaws provide indemnification for our directors and officers to the fullest extent permitted by the DGCL, along
with the right to have expenses incurred in defending proceedings paid in advance of their final disposition. We have employment
agreements with each of our executive officers that may, in some cases, be broader than the specific indemnification and
advancement provisions contained under our amended and restated bylaws and provided under Delaware law. In addition, as permitted by
Delaware law, our amended and restated certificate of incorporation includes provisions that eliminate the personal liability of our
directors for monetary damages resulting from breaches of certain fiduciary duties as a director. The effect of this provision is to
restrict our rights and the rights of our stockholders to recover monetary damages against a director for breach of fiduciary duties
as a director.
Insofar
as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling our
company pursuant to the foregoing provisions, we have been informed that, in the opinion of the SEC, such indemnification is against
public policy as expressed in the Securities Act, and is, therefore, unenforceable.
Corporate
Opportunity Doctrine
Delaware
law permits corporations to adopt provisions renouncing any interest or expectancy in certain opportunities that are presented to the
corporation or its officers, directors or stockholders. Our amended and restated certificate of incorporation will, to the maximum extent
permitted from time to time by Delaware law, renounce any interest or expectancy that we have in, or right to be offered an opportunity
to participate in, specified business opportunities that are from time to time presented to our officers, directors or certain of our
stockholders or their respective affiliates, other than those opportunities our officers, directors, stockholders or affiliates are presented
with while acting in their capacity as an employee, officer or director of us or our affiliates. Our amended and restated certificate
of incorporation provides that, to the fullest extent permitted by law, any director or stockholder who is not employed by us or our
affiliates will not have any duty to refrain from (i) engaging in a corporate opportunity in the same or similar lines of business in
which we or our affiliates now engage or propose to engage; or (ii) otherwise competing with us or our affiliates. In addition, to the
fullest extent permitted by law, if any director or stockholder, other than a director or stockholder who is employed by us or our affiliates
acting in their capacity as an employee or director of us or our affiliates, acquires knowledge of a potential transaction or other business
opportunity which may be a corporate opportunity for itself or himself or its or his affiliates or for us or our affiliates, such person
will have no duty to communicate or offer such transaction or business opportunity to us or any of our affiliates and they may take any
such opportunity for themselves or offer it to another person or entity. To the fullest extent permitted by Delaware law, no potential
transaction or business opportunity may be deemed to be a corporate opportunity of ours or any subsidiary. Our amended and restated certificate
of incorporation will not renounce our interest in any business opportunity that is expressly offered to an employee director, employee
officer or employee in his or her capacity as a director, officer or employee of Biofrontera Inc.
Dissenters’
Rights of Appraisal and Payment
Under
the DGCL, with certain exceptions, our stockholders will have appraisal rights in connection with a merger or consolidation of Biofrontera
Inc. Pursuant to the DGCL, stockholders who properly demand and perfect appraisal rights in connection with such mergers or consolidations
will have the right to receive payment of the fair value of their shares as determined by the Delaware Court of Chancery, subject to
certain limitations.
Stockholders’
Derivative Actions
Under
the DGCL, any of our stockholders may bring an action in our name to procure a judgment in our favor, also known as a derivative action,
in certain circumstances. Among other things, either the stockholder bringing any such action must be a holder of our shares at the time
of the transaction to which the action relates or such stockholder’s stock must have thereafter devolved by operation of law, and
such stockholder must continuously hold shares through the resolution of such action.
Transfer
Agent and Registrar
The
transfer agent and registrar for our common stock is Computershare Trust Company, N.A.
Trading
Symbol and Market
Our
common stock is traded on The Nasdaq Capital Market under the symbol “BFRI.”
PRIVATE
PLACEMENT OF SHARES OF COMMON STOCK AND WARRANTS
2022
Private Placement
On
May 16, 2022,we entered into a Securities Purchase Agreement, or the 2022 Purchase Agreement, with the same institutional investor as
the 2021 Private Placement, pursuant to which we agreed to sell in a private placement at an aggregate purchase price of approximately
$9,400,000, (i) 1,850,000 shares of our common stock, or the 2022 PIPE Shares, (ii) a common stock purchase warrant to purchase up to
3,419,000 shares of our common stock, or the 2022 Purchaser Warrant, and (iii) a pre-funded common stock purchase warrant to purchase
up to 1,569,000 shares of our common stock, or the 2022 Pre-Funded Warrant, and together with the 2022 Purchaser Warrant and the 2022
PIPE Shares, the 2022 PIPE Securities. The 2022 Purchaser Warrant will be exercisable six months
after the issue date, expires five and one-half years after the issue date and has an exercise price of: $2.77 per share. The 2022 Pre-Funded
Warrant is exercisable immediately and has a term of exercise equal to five (5) years with a nominal exercise price of $0.001 per share.
The combined purchase price for one 2022 PIPE Share and one 2022 Purchaser Warrant was $2.75 and the combined purchase price for one
2022 Pre-Funded Warrant and one 2022 Purchaser Warrant was $2.749.
The
investor in the 2022 Private Placement has contractually agreed to restrict its ability to exercise the 2022 Purchaser Warrant and the
2022 Pre-Funded Warrant such that the number of shares of the Company’s common stock held by the investor and its affiliates after
such exercise does not exceed either 4.99%, in the case of the 2022 Purchaser Warrant, or 9.99%, in the case of the 2022 Pre-Funded Warrant,
of the then issued and outstanding shares of the Company’s common stock. The investor may increase or decrease these limitations
upon notice to the Company, but in no event will any such limitation exceed 9.99%.
In
connection with the 2022 Purchase Agreement, we entered into a registration rights agreement (the “Registration Rights Agreement”)
with the investor. Pursuant to the Registration Rights Agreement, we are required to confidentially submit a resale registration statement
on Form S-1, or the 2022 Resale Registration Statement, with the Securities and Exchange Commission, or the SEC, to register for resale
the 2022 PIPE Securities and to have the 2022 Resale Registration Statement declared effective within 30 days of the confidential submission,
or 45 days in the event the 2022 Resale Registration Statement is “fully” reviewed by the SEC. The Company will be obligated
to pay certain liquidated damages if the Company fails to file the 2022 Resale Registration Statement when required, fails to file or
cause the 2022 Resale Registration Statement to be declared effective by the SEC when required, or fails to maintain the effectiveness
of the 2022 Resale Registration Statement pursuant to the terms of the Registration Rights Agreement.
2021
Private Placement
On
November 29, 2021,we entered into a Securities Purchase Agreement, or the 2021 Purchase Agreement, with a single institutional investor,
pursuant to which we agreed to sell in a private placement at an aggregate purchase price of approximately $15,000,000, (i) 1,350,000
shares of our common stock, or the 2021 PIPE Shares, (ii) a common stock purchase warrant to purchase up to 2,857,143 shares of our common
stock, or the 2021 Purchaser Warrant and (iii) a pre-funded common stock purchase warrant to purchase up to 1,507,143 shares of our common
stock, or the 2021 Pre-Funded Warrant and together with the 2021 Purchaser Warrant and the 2021 PIPE Shares, the 2021 PIPE Securities.
Each of the 2021 Purchaser Warrant and 2021 Pre-Funded Warrant is exercisable immediately and has a term of exercise equal to five (5)
years with an exercise price of: (a) $5.25 per share with respect to the 2021 Purchaser Warrant and (b) a nominal exercise price of $0.0001
per share with respect to the 2021 Pre-Funded Warrant. The combined purchase price for one 2021 PIPE Share and one 2021 Purchaser Warrant
was $5.25 and the combined purchase price for one 2021 Pre-Funded Warrant and one Purchaser Warrant was $5.24.
The
investor in the 2021 Private Placement has contractually agreed to restrict its ability to exercise the 2021 Purchaser Warrant and the
2021 Pre-Funded Warrant such that the number of shares of the Company’s common stock held by the investor and its affiliates after
such exercise does not exceed either 4.99%, in the case of the 2021 Purchaser Warrant, or 9.99%, in the case of the 2021 Pre-Funded Warrant,
of the then issued and outstanding shares of the Company’s common stock. The investor may increase or decrease these limitations
upon notice to the Company, but in no event will any such limitation exceed 9.99%.
On
December 2021, we filed a registration statement on Form S-1 registering the resale of the 2021 PIPE Securities by the investor, that
was declared effective on December 23, 2021. The 2021 Pre-funded Warrants were exercised in full in December 2021.
SELLING
STOCKHOLDER
The
common stock being offered by the Selling Stockholder are those previously issued to the Selling Stockholder, and those
issuable to the Selling Stockholder, upon exercise of the warrants. For additional information regarding the issuances of those
shares of common stock and warrants, see “Private Placement of Shares of Common Stock and Warrants” above. We are
registering the shares of common stock in order to permit the Selling Stockholder to offer the shares for resale from time to
time. Except for the ownership of the shares of common stock and the warrants issued in the 2021 Private Placement and the 2022 Private
Placement, the Selling Stockholder has not had any material relationship with us within the past three years.
The
table below lists the Selling Stockholder and other information regarding the beneficial ownership of the shares of common stock by the
Selling Stockholder. The second column lists the number of shares of common stock beneficially owned by the Selling Stockholder, based
on its ownership of the shares of common stock and warrants, as of June 6, 2022. The third column lists the shares of common stock
being offered by the Selling Stockholder as part of this public offering. The fourth column assumes the sale of all of the shares offered
by the Selling Stockholder pursuant to this prospectus.
In
accordance with the terms of the Registration Rights Agreement with the Selling Stockholder, this prospectus generally covers the resale
of the sum of (i) the number of shares of common stock issued to the Selling Stockholder in the 2022 Private Placement and (ii)
the maximum number of shares of common stock issuable upon exercise of the related warrants issued in the 2022 Private Placement, and
this prospectus also covers the unsold securities from the 2021 Private Placement; in each case, determined as if the outstanding warrants
were exercised in full as of the trading day immediately preceding the date this registration statement was initially filed with the
SEC, each as of the trading day immediately preceding the applicable date of determination and all subject to adjustment as provided
in the registration right agreement, without regard to any limitations on the exercise of the warrants. The fourth column assumes the
sale of all of the shares offered by the Selling Stockholder pursuant to this prospectus.
Under
the terms of the warrants, the Selling Stockholder may not exercise the warrants to the extent such exercise would cause the
Selling Stockholder, together with its affiliates and attribution parties, to beneficially own a number of shares of common stock
which would exceed 4.99% or 9.99%, as applicable, of our then outstanding common stock following such exercise, excluding for purposes
of such determination shares of common stock issuable upon exercise of such warrants which have not been exercised. The number of shares
in the second and fourth columns do not reflect this limitation. The Selling Stockholder may sell all, some or none of their shares
in this offering. See “Plan of Distribution.”
| Name of Selling Stockholder | |
Number of shares of Common Stock Owned Prior to Offering | | |
Maximum Number of shares of Common Stock to be Sold Pursuant to this Prospectus | | |
Number of shares of Common Stock Owned After Offering | |
Armistice Capital Master Fund Ltd. c/o Armistice Capital, LLC
510 Madison Avenue, 7th Floor
New York, New York 10022 | |
| 9,695,143 | (1) | |
| 9,695,143 | | |
| 0 | |
(1)
The shares of Common Stock reported herein are held by the Master Fund and may be deemed to be indirectly beneficially owned by (i) Armistice
Capital, as the investment manager of the Master Fund; and (ii) Steven Boyd, as the Managing Member of Armistice Capital. Armistice Capital
and Steven Boyd disclaim beneficial ownership of the securities except to the extent of their respective pecuniary interests therein.
Of the total number of shares reported herein, 1,569,000 shares are issuable only upon the exercise of the 2022 Pre-Funded Warrants,
3,419,000 shares are issuable only upon the exercise of the 2022 Purchaser Warrants and 2,857,143 shares are issuable only upon the exercise
of the 2021 Purchaser Warrants, all of which are subject to beneficial ownership limitations that prohibit the Master Fund from exercising
any portion of those warrants if such exercise would result in the Master Fund owning a percentage of our outstanding Common Stock exceeding
the applicable ownership limitation (9.99% for the 2022 Pre-Funded Warrants and 4.99% for the 2022 Purchaser Warrants and the 2021 Purchaser
Warrants) after giving effect to the issuance of common stock in connection with the Master Fund’s exercise of any portion of either
such warrant.
PLAN
OF DISTRIBUTION
The
Selling Stockholder of the securities and any of its pledgees, assignees and successors-in-interest
may, from time to time, sell any or all of its securities covered hereby on the Nasdaq Capital Market or any other stock exchange, market
or trading facility on which the securities are traded or in private transactions. These sales may be at fixed or negotiated prices.
The Selling Stockholder may use any one or more of the following methods when selling securities:
| |
● |
ordinary
brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
| |
|
|
| |
● |
block
trades in which the broker-dealer will attempt to sell the securities as agent but may position and resell a portion of the block
as principal to facilitate the transaction; |
| |
|
|
| |
● |
purchases
by a broker-dealer as principal and resale by the broker-dealer for its account; |
| |
|
|
| |
● |
an
exchange distribution in accordance with the rules of the applicable exchange; |
| |
|
|
| |
● |
privately
negotiated transactions; |
| |
|
|
| |
● |
settlement
of short sales; |
| |
|
|
| |
● |
in
transactions through broker-dealers that agree with the Selling Stockholder to sell a specified number of such securities at a stipulated
price per security; |
| |
|
|
| |
● |
through
the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; |
| |
|
|
| |
● |
a
combination of any such methods of sale; or |
| |
|
|
| |
● |
any
other method permitted pursuant to applicable law. |
The
Selling Stockholder may also sell securities under Rule 144 or any other exemption from registration under the Securities Act, if available,
rather than under this prospectus. Broker-dealers engaged by the Selling Stockholder may arrange for other brokers-dealers to participate
in sales. Broker-dealers may receive commissions or discounts from the Selling Stockholder (or, if any broker-dealer acts as agent for
the purchaser of securities, from the purchaser) in amounts to be negotiated, but, except as set forth in a supplement to this Prospectus,
in the case of an agency transaction not in excess of a customary brokerage commission in compliance with FINRA Rule 2121; and in the
case of a principal transaction a markup or markdown in compliance with FINRA Rule 2121.
In
connection with the sale of the securities or interests therein, the Selling Stockholder may enter into hedging transactions with broker-dealers
or other financial institutions, which may in turn engage in short sales of the securities in the course of hedging the positions they
assume. The Selling Stockholder may also sell securities short and deliver these securities to close out their short positions, or loan
or pledge the securities to broker-dealers that in turn may sell these securities. The Selling Stockholder may also enter into option
or other transactions with broker-dealers or other financial institutions or create one or more derivative securities which require the
delivery to such broker-dealer or other financial institution of securities offered by this prospectus, which securities such broker-dealer
or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).
The
Selling Stockholder and any broker-dealers or agents that are involved in selling the securities may be deemed to be “underwriters”
within the meaning of the Securities Act in connection with such sales. In such event, any commissions received by such broker-dealers
or agents and any profit on the resale of the securities purchased by them may be deemed to be underwriting commissions or discounts
under the Securities Act. The Selling Stockholder has informed the Company that it does not have any written or oral agreement or understanding,
directly or indirectly, with any person to distribute the securities.
The
Company is required to pay certain fees and expenses incurred by the Company incident to the registration of the securities. The Company
has agreed to indemnify the Selling Stockholder against certain losses, claims, damages and liabilities, including liabilities under
the Securities Act.
We
agreed to keep this prospectus effective until the earlier of (i) the date on which the securities may be resold by the Selling Stockholder
without registration and without regard to any volume or manner-of-sale limitations by reason of Rule 144, without the requirement for
the Company to be in compliance with the current public information under Rule 144 under the Securities Act or any other rule of similar
effect or (ii) all of the securities have been sold pursuant to this prospectus or Rule 144 under the Securities Act or any other rule
of similar effect. The resale securities will be sold only through registered or licensed brokers or dealers if required under applicable
state securities laws. In addition, in certain states, the resale securities covered hereby may not be sold unless they have been registered
or qualified for sale in the applicable state or an exemption from the registration or qualification requirement is available and is
complied with.
Under
applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale securities may not simultaneously
engage in market making activities with respect to the common stock for the applicable restricted period, as defined in Regulation M,
prior to the commencement of the distribution. In addition, the Selling Stockholder will be subject to applicable provisions of the Exchange
Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of the common
stock by the Selling Stockholder or any other person. We will make copies of this prospectus available to the Selling Stockholder and
have informed them of the need to deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including
by compliance with Rule 172 under the Securities Act).
LEGAL
MATTERS
The
validity of the securities offered hereby will be passed upon for us by McGuireWoods LLP, New York, New York.
EXPERTS
The
audited financial statements, incorporated by reference in this prospectus and elsewhere
in the registration statement have been so incorporated by reference in reliance upon the report of Grant Thornton LLP, independent registered
public accountants, upon the authority of said firm as experts in accounting and auditing.
WHERE
YOU CAN FIND MORE INFORMATION
We
have filed with the SEC a registration statement on Form S-1 under the Securities Act with respect to the securities offered hereby.
This prospectus, which constitutes a part of the registration statement, does not contain all of the information set forth in the registration
statement or the exhibits and schedules filed with the registration statement. For further information about us and the securities offered
hereby, we refer you to the registration statement and the exhibits filed with the registration statement. Statements contained in this
prospectus regarding the contents of any contract or any other document that is filed as an exhibit to the registration statement are
not necessarily complete, and each such statement is qualified in all respects by reference to the full text of such contract or other
document filed as an exhibit to the registration statement. The SEC also maintains an internet website that contains reports, proxy statements
and other information about registrants, like us, that file electronically with the SEC. The address of that website is www.sec.gov.
We
are required to file periodic reports, proxy statements, and other information with the SEC pursuant to the Exchange Act. These reports,
proxy statements, and other information will be available on the website of the SEC referred to above.
We
maintain a website at www.biofrontera-us.com, through which you may access these materials free of charge as soon as reasonably
practicable after they are electronically filed with, or furnished to, the SEC. Information contained on or accessed through our website
is not a part of this prospectus and the inclusion of our website address in this prospectus is an inactive textual reference only.
INCORPORATION
BY REFERENCE
The
SEC allows us to “incorporate by reference” information from other documents that we file with it, which means that we can
disclose important information to you by referring you to those documents. The information incorporated by reference is considered to
be part of this prospectus. Information in this prospectus supersedes information incorporated by reference that we filed with the SEC
prior to the date of this prospectus.
We
incorporate by reference into this prospectus and the registration statement of which this prospectus is a part the information or documents
listed below that we have filed with the SEC:
| |
● |
our
Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on April 11, 2022; |
| |
● |
our
Quarterly Report on Form 10-Q for the three months ended March 31, 2022, filed with the SEC on May 13, 2022 |
| |
● |
our
Current Reports on Form 8-K filed with the SEC on March 8, 2022 (as amended on May 24, 2022), April 5, 2022, May 20, 2022 and May 24, 2022; and |
| |
● |
the
description of our common stock contained in our registration statement on Form 8-A filed with the SEC on October 20, 2021, including
any amendments or reports filed for the purposes of updating this description. |
In
addition, all documents (other than current reports furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits filed on such form
that are related to such items) that are filed by us with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act
after the date of the initial registration statement of which this prospectus is a part and prior to the effectiveness of such registration
statement and all documents subsequently filed by us pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act prior to the
termination of the offering (excluding any information furnished rather than filed) shall be deemed to be incorporated by reference into
this prospectus.
Notwithstanding
the statements in the preceding paragraphs, no document, report or exhibit (or portion of any of the foregoing) or any other information
that we have “furnished” to the SEC pursuant to the Exchange Act shall be incorporated by reference into this prospectus.
We
will furnish without charge to you, on written or oral request, a copy of any or all of the documents incorporated by reference in this
prospectus, including exhibits to these documents. You should direct any requests for documents to Biofrontera Inc., 120 Presidential
Way, Suite 330, Woburn, MA 01801 or call 781-245-1325. You also may access these filings on our website at www.biofrontera-us.com. We
do not incorporate the information on our website into this prospectus and you should not consider any information on, or that can be
accessed through, our website as part of this prospectus (other than those filings with the SEC that we specifically incorporate by reference
into this prospectus).
Any
statement contained in a document incorporated or deemed to be incorporated by reference in this prospectus will be deemed modified,
superseded or replaced for purposes of this prospectus to the extent that a statement contained in this prospectus modifies, supersedes
or replaces such statement.
9,695,143
Shares of Common Stock Offered by the Selling Stockholder
Biofrontera (NASDAQ:BFRI)
Historical Stock Chart
From Mar 2024 to Apr 2024
Biofrontera (NASDAQ:BFRI)
Historical Stock Chart
From Apr 2023 to Apr 2024
