Full Press Release Details
Inc. Reports Third Quarter 2021 Financial Results and Provides Business Update
call at 4:30 p.m. Eastern time today
Mass., November 30, 2021 - Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization
of dermatological products, announced today financial results for the three and nine months ended September 30, 2021.
Highlights & Recent News
| Recorded total revenues for the quarter of $4.3 million, an increase of 33% from last year | ||
| Recorded total revenues year-to-date of $14.9 million, an increase of 45% from last year | ||
| Raised $18 million in gross proceeds through an initial public offering (IPO) and subsequently entered into a $15 million private placement, with all proceeds to be received in the fourth quarter | ||
| Initiated two clinical studies to expand the positioning of Ameluz for photodynamic therapy (PDT) in the U.S. |
am so very proud of the Biofrontera team for all their hard work to support our successful Nasdaq IPO while advancing our business plan.
The IPO proceeds together with the funds from the private placement enable us to achieve our near-term goals, including expanding our
commercial position across the U.S. and driving market awareness. We have experienced an encouraging sales trend since March with a 45%
increase in year-to-date product revenue compared with last year, indicating that product demand is recovering from the COVID-19 pandemic,"
stated Erica Monaco, Chief Executive Officer of Biofrontera Inc.
clinical study program governed by our license and supply agreement with Biofrontera AG continues to advance on schedule and is a key
component of driving further value from our licensed flagship product. Two clinical studies have recently launched, both of which aim
to expand the label of Ameluz to optimize its competitive position and capture more of the significant market opportunity,"
Quarter Financial Results
revenues were $4.3 million and $3.3 million for the three months ended September 30, 2021 and 2020, respectively, an increase of $1.1
million, or 33%. The increase was primarily due to higher sales of Ameluz , reflecting volume increases and a higher net selling
operating expenses were $20.4 million and $5.6 million for the three months ended September 30, 2021 and 2020, respectively. Cost of
revenues increased by $1.3 million primarily due to higher sales of Ameluz . Selling, general and administrative expenses increased
by $12.9 million primarily due to a one time legal settlement expense, marketing campaign expenses and increased headcount.
loss was $16.0 million and $3.0 million for the three months ended September 30, 2021 and 2020, respectively.
EBITDA was negative $3.8 million and negative $3.1 million for the three months ended September 30, 2021 and 2020, respectively. Adjusted
EBITDA, a non-GAAP financial measure, is defined as net income or loss excluding, interest income and expense, income taxes, depreciation
and amortization, legal settlement expense and certain other non-recurring or non-cash items.
and cash equivalents as of September 30, 2021 were $1.7 million. On October 28, 2021 Biofrontera Inc. raised estimated net proceeds of
$15.4 million from an IPO of 3,600,000 units, with each unit consisting of one share of common stock and one warrant to purchase a share
of common stock. The Company continues to believe that funds available under the Second Intercompany Revolving Loan Agreement along with
net proceeds from the IPO, warrants exercised, and the private securities placement provide sufficient capital to support operating,
investing and financing activities through at least the next 12 months.
Month Financial Results
revenues were $14.9 million and $10.3 million for the nine months ended September 30, 2021 and 2020, respectively, an increase of $4.7
million, or 45%. The increase was primarily due to higher sales of Ameluz , partially offset by lower sales of Xepi .
operating expenses were $38.3 million and $19.7 million for the nine months ended September 30, 2021 and 2020, respectively. Operating
expenses for the most recent nine months include the aforementioned one time legal settlement expense.
loss was $23.2 million and $10.8 million for the nine months ended September 30, 2021 and 2020, respectively.
EBITDA was negative $9.5 million and negative $9.1 million for the nine months ended September 30, 2021 and 2020, respectively.
table below presents a reconciliation from net loss to Adjusted EBITDA for the three and nine months ended September 31, 2021 and 2021:
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Net income/(loss) | $ | (16,012 | ) | $ | (2,985 | ) | $ | (23,208 | ) | $ | (10,801 | ) | ||||
| Interest expense, net | 86 | 744 | 255 | 2,113 | ||||||||||||
| Income tax expenses | 6 | 61 | 51 | 66 | ||||||||||||
| Depreciation and amortization | 134 | 141 | 409 | 423 | ||||||||||||
| EBITDA | (15,786 | ) | (2,039 | ) | (22,493 | ) | (8,199 | ) | ||||||||
| Change in fair value of contingent consideration | 700 | 100 | 1,698 | 238 | ||||||||||||
| Cost reimbursement from Biofrontera Pharma GmbH | - | (1,188 | ) | - | (1,188 | ) | ||||||||||
| Legal settlement expenses | 11,250 | - | 11,250 | - | ||||||||||||
| Adjusted EBITDA | $ | (3,836 | ) | $ | (3,127 | ) | $ | (9,545 | ) | $ | (9,149 | ) | ||||
| Adjusted EBITDA margin | -88.5 | % | -96.2 | % | -63.9 | % | -89.0 | % |
Call and Webcast Information
Inc. will hold a conference call today at 4:30 p.m. Eastern time to discuss these results and answer questions.
| Date: | Tuesday, November 30, 2021 |
| Time: | 4:30 p.m. Eastern time |
| Conference Call: | 1-866-524-3160 (U.S.) |
| 1-412-317-6760 (outside the U.S.) | |
| Webcast: | Live and 90-day replay webcast are available here and at www.investors.biofrontera-us.com . |
Inc. is a U.S.-based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatological
conditions. With a focus on the fields of photodynamic therapy (PDT) and topical antibiotics, Biofrontera currently commercializes the
FDA-approved flagship drug Ameluz in the United States. When used in combination with PDT and Biofrontera's BF-RhodoLED
lamp, Ameluz -PDT is indicated for the treatment of actinic keratoses (AK), one of the most common precancerous skin conditions.
Biofrontera also commercializes Xepi , an FDA-approved drug for the treatment of impetigo. In collaboration with dermatologists,
Biofrontera is fully committed to advancing treatment options and patient care. For more information, visit www.biofrontera-us.com.
statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private
Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to
the financial impact and benefits of the Company's recent initial public offering and private placement, the clinical developments
involving the Company's licenses products and any other statements about future Expectations, prospects, estimates and other matters
that are dependent on future events or developments. Statements containing the words "anticipate," "believe,"
"estimate," "expect," "intend," "may," "plan," "predict," "project,"
"target," "potential," "likely," "will," "would," "could," "should,"
"continue," and similar expressions constitute 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. These risks and uncertainties,
many of which are beyond our control, including, but not limited to, the impact of extraordinary external events, such as the current
COVID-19 pandemic; any changes in the Company's relationship with its licensors; the outcome of the Company's litigation
with DUSA Pharmaceuticals, Inc.; the Company's ability to achieve and sustain profitability; whether the current disruptions in
the supply chain will impact the Company's ability to obtain and distribute its licensed products; changes in the practices of
healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company's licensed
products; the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical
trials; whether results of early clinical trials or trials in different disease indications will be indicative of the results of ongoing
or future trials; whether results of the studies described above will be indicative of results for any future clinical trials and studies
of Ameluz in combination with BF-RhodoLED ; uncertainties associated with regulatory review of clinical trials and applications
for marketing approvals; whether the market opportunity for Ameluz in combination with BF-RhodoLED is consistent with the Company's
expectations; whether the Company will be able to successfully transition to a public company operating independently of Biofrontera
AG; the Company's ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing
and other factors that may be disclosed in the Company's filings with the SEC, which can be obtained on the SEC website at www.sec.gov.
Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are
made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any
such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as
thousands, except par value and share amount)
| September 30, 2021 | December 31, 2020 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 1,716 | $ | 8,080 | ||||
| Accounts receivable, net | 2,007 | 3,216 | ||||||
| Accounts receivable, related parties | 39 | 73 | ||||||
| Inventories | 5,439 | 7,091 | ||||||
| Prepaid expenses and other current assets | 936 | 1,116 | ||||||
| Total current assets | 10,137 | 19,576 | ||||||
| Property and equipment, net | 289 | 370 | ||||||
| Intangible asset, net | 3,555 | 3,869 | ||||||
| Other assets | 1,373 | 323 | ||||||
| Total assets | $ | 15,354 | $ | 24,138 | ||||
| LIABILITIES AND STOCKHOLDER'S EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 367 | $ | 176 | ||||
| Accounts payable, related parties | 1,662 | 1,538 | ||||||
| Accrued expenses and other current liabilities | 9,262 | 2,706 | ||||||
| Total current liabilities | 11,291 | 4,420 | ||||||
| Long-term liabilities: | ||||||||
| Acquisition contract liabilities, net | 15,795 | 13,828 | ||||||
| Other liabilities | 5,648 | 62 | ||||||
| Total liabilities | $ | 32,734 | $ | 18,310 | ||||
| Commitments and contingencies (see Note 18) | ||||||||
| Stockholder's equity(deficit): | ||||||||
| Common Stock, $0.001 par value, 300,000,000 shares authorized; 8,000,000 shares issued and outstanding | $ | 8 | $ | 8 | ||||
| Additional paid-in capital | 46,986 | 46,986 | ||||||
| Accumulated deficit | (64,374 | ) | (41,166 | ) | ||||
| Total stockholder's equity (deficit) | (17,380 | ) | 5,828 | |||||
| Total liabilities and stockholder's equity (deficit) | $ | 15,354 | $ | 24,138 |
thousands, except per share amounts and number of shares)
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Products revenues, net | $ | 4,319 | $ | 3,236 | $ | 14,890 | $ | 10,230 | ||||||||
| Revenues, related party | 15 | 16 | 42 | 47 | ||||||||||||
| Total revenues, net | 4,334 | 3,252 | 14,932 | 10,277 | ||||||||||||
| Operating expenses | ||||||||||||||||
| Cost of revenues, related party | 2,249 | 567 | 7,630 | 4,025 | ||||||||||||
| Cost of revenues, other | 41 | 446 | 339 | 617 | ||||||||||||
| Selling, general and administrative | 17,090 | 4,191 | 27,412 | 13,557 | ||||||||||||
| Selling, general and administrative, related party | 160 | 111 | 520 | 397 | ||||||||||||
| Restructuring costs | 199 | 181 | 654 | 861 | ||||||||||||
| Change in fair value of contingent consideration | 700 | 100 | 1,698 | 238 | ||||||||||||
| Total operating expenses | 20,439 | 5,596 | 38,253 | 19,695 | ||||||||||||
| Loss from operations | (16,105 | ) | (2,344 | ) | (23,321 | ) | (9,418 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Interest expense, net | (86 | ) | (744 | ) | (255 | ) | (2,113 | ) | ||||||||
| Other income (expense), net | 185 | 164 | 419 | 796 | ||||||||||||
| Total other income (expense) | 99 | (580 | ) | 164 | (1,317 | ) | ||||||||||
| Loss before income taxes | (16,006 | ) | (2,924 | ) | (23,157 | ) | (10,735 | ) | ||||||||
| Income tax expense | 6 | 61 | 51 | 66 | ||||||||||||
| Net loss | $ | (16,012 | ) | $ | (2,985 | ) | $ | (23,208 | ) | $ | (10,801 | ) | ||||
| Loss per common share: | ||||||||||||||||
| Basic and diluted | $ | (2.00 | ) | $ | (2,984.67 | ) | $ | (2.90 | ) | $ | (10,800.96 | ) | ||||
| Weighted-average common shares outstanding: | ||||||||||||||||
| Basic and diluted | 8,000,000 | 1,000 | 8,000,000 | 1,000 |