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.
Financial
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.
Management Commentary
“I 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.
“The 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,” she added.
Third Quarter Financial
Results
Total 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 price.
Total 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.
Net loss was $16.0 million and $3.0 million for
the three months ended September 30, 2021 and 2020,
respectively.
Adjusted 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.
Cash 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.
Nine Month Financial
Results
Total 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®.
Total 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.
Net loss was $23.2 million and $10.8 million for
the nine months ended September 30, 2021 and 2020,
respectively.
Adjusted EBITDA was negative $9.5 million and
negative $9.1 million for the nine months ended September 30, 2021
and 2020, respectively.
The 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 endedSeptember
30, |
|
|
Nine months endedSeptember
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 |
% |
Conference Call and Webcast
Information
Biofrontera 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. |
About Biofrontera
Inc.
Biofrontera 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.
Forward-Looking Statements
Certain 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
required by law.
Contacts
Biofrontera Inc.Pamela Keck+1
781 486 1539us-ir@biofrontera.com
LHA Investor RelationsTirth T.
Patel+1 212 201 6614tpatel@lhai.com
(Tables to follow)BIOFRONTERA
INC.BALANCE
SHEETS(In thousands, except par
value and share amount) (Unaudited)
|
|
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 |
|
BIOFRONTERA
INC.STATEMENTS OF
OPERATIONS(In thousands, except
per share amounts and number of
shares)(Unaudited)
|
|
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 |
|
# # #
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