1.
Business Overview
We
are a U.S.-based biopharmaceutical company specializing in the commercialization of pharmaceutical products for the treatment of dermatological
conditions, in particular, diseases caused primarily by exposure to sunlight that results in sun damage to the skin. Our principal licensed
products focus on the treatment of actinic keratoses, which are skin lesions that can sometimes lead to skin cancer. We also market a
licensed topical antibiotic for treatment of impetigo, a bacterial skin infection.
Our
principal product is Ameluz®, which is a prescription drug approved for use in combination with our licensor’s FDA-approved
medical device, the BF-RhodoLED® lamp series, for photodynamic therapy (“PDT”) (when used together, “Ameluz ®
PDT”) in the U.S. for the lesion-directed and field-directed treatment of actinic keratosis of mild-to-moderate severity
on the face and scalp. We are currently selling Ameluz® for this indication in the U.S. under an exclusive license and supply agreement
(“Ameluz LSA”), by and among us and Biofrontera Pharma GmbH and Biofrontera Bioscience GmbH (collectively, the (“Ameluz
Licensor”) originally dated as of October 1, 2016, and as subsequently amended on October 8, 2021. Refer to Note 16, Related
Party Transactions, for further details.
Our
second prescription drug product is Xepi® (ozenoxacin cream, 1%), a topical non-fluorinated quinolone that inhibits bacterial growth.
Currently, no antibiotic resistance against Xepi® is known and it has been specifically approved by the FDA for the treatment of
impetigo due to staphylococcus aureus or streptococcus pyogenes. The approved indication is impetigo, a common skin infection. It is
approved for use in adults and children 2 months and older. We are currently selling Xepi® for this indication in the U.S. under
an exclusive license and supply agreement (“Xepi LSA”) with Ferrer Internacional S.A. (“Ferrer”) that
was acquired by Biofrontera Inc. on March 25, 2019 through our acquisition of Cutanea Life Sciences, Inc. Refer to Note 16, Related
Party Transactions, for further details.
Liquidity
and Going Concern
The
Company’s primary sources of liquidity are its existing cash balances and cash flows from equity financing transactions received
in 2021. As of March 31, 2022, we had cash and cash equivalents of $ 22.4 million, compared to $ 24.5 million as of December 31, 2021.
Since
we commenced operations in 2015, we have generated significant losses. For the three months ended March 31, 2022 and 2021, we incurred
losses from operations of $ 3.1 million and $ 3.5 million, respectively. We incurred net cash outflows from operations of $ 2.1 million
and $ 3.4 million, for the same periods, respectively. We had an accumulated deficit as of March 31, 2022 of $ 73.3 million.
The
Company’s short-term material cash requirements include working capital needs and satisfaction of contractual commitments including
auto leases (see Note 23, Commitments and Contingencies), Maruho start-up payments of $ 7.3
million (see Note 3. Acquisition Contract
Liabilities), and legal settlement expenses after reimbursement from Biofrontera AG, a significant shareholder and our former
parent company, of $ 5.6
million (see Note 13. Accrued Expenses and Other Current
Liabilities). Long-term material cash requirements include potential milestone payments to Ferrer Internacional S.A (see Note
23. Commitments and Contingencies) and contingent consideration payments to Maruho (see Note 3. Acquisition Contract Liabilities).
Additionally,
we expect to continue to incur operating losses due to significant discretionary sales and marketing efforts as we seek to expand the
commercialization of Ameluz ® and Xepi ® in the United States. We also expect to incur additional expenses
to add and improve operational, financial and information systems and personnel, including personnel to support our product commercialization
efforts. In addition, we expect to incur significant
Free historical financial statements for Biofrontera Inc..
See how revenue, income, cash flow, and balance sheet financials have changed over 13 quarters since 2021. Compare with BFRI stock chart to see long term trends.
Data imported from Biofrontera Inc. SEC filings. Check original filings before making any investment decision.