Biofrontera
Inc. (Nasdaq: BFRI)
(the “Company”)
, a biopharmaceutical company
specializing in the commercialization of dermatological products,
today announced financial results for the three and 12 months ended
December 31, 2021, and provided a business update.
Financial Highlights
- Total revenues for the fourth
quarter of 2021 were $9.2 million, an increase of 7% from the prior
year
- Total revenues for 2021 were $24.1
million, an increase of 28% from the prior year
- Cash and cash equivalents were
$24.5 million as of December 31, 2021
- Raised gross proceeds of $18
million from an initial public offering (IPO) and $15 million from
a subsequent private placement
- Raised $13 million from the
exercise of outstanding warrants, reducing Biofrontera AG’s
ownership of Biofrontera Inc. to less than 50%
Clinical and Operational
Highlights
- Initiated two clinical studies to
expand the Ameluz® photodynamic therapy (PDT) market opportunity in
the U.S.
- Enrolled the first subject in a
Phase 1 safety study evaluating PDT with three tubes of
Ameluz®
- Enrolled the first subject in a
Phase 2b study evaluating Ameluz® + BF-RhodoLED® (Ameluz®-PDT) in
moderate-to-severe acne
- Continued recruitment of subjects
in a Phase 3 study evaluating Ameluz®-PDT for the treatment of
basal cell carcinoma
- Appointed Kevin Weber, a
pharmaceutical executive with more than 30 years of executive and
commercial experience, to the Company’s Board of Directors
- Received notices of allowance for
U.S. patents on a PDT illumination protocol and an illumination
device
- Received U.S. regulatory clearance
for the RhodoLED® XL lamp
- Received Orange Book listing for a
RhodoLED® XL lamp patent, providing Ameluz®-PDT with protection
from generic competition through October 2040
Management Commentary
“2021 was a foundational year for Biofrontera
Inc. From completing our IPO in October to laying the groundwork
for expanding the label of our flagship product Ameluz®, I’m proud
of the hard work by our team in executing Biofrontera’s strategic
vision. We entered 2022 with the capital, commercial momentum and
strategic plan in place to build shareholder value,” said Erica
Monaco, Chief Executive Officer of Biofrontera Inc.
“Despite continued challenges resulting from the
COVID-19 pandemic, we returned to topline growth in 2021 and sales
have now recovered to near pre-pandemic levels including a
seasonally strong fourth quarter. In 2021 we increased our market
share within the PDT drug segment to approximately 26%, up from
approximately 24% in the previous year. We expect the momentum
established in 2021 will continue to drive revenue growth from top
customer accounts as the opportunity to gain share from cryotherapy
remains a key focus of our commercial efforts. Our goal is to
continue to improve the market positioning of Ameluz® to become the
leading PDT drug for the treatment of actinic keratosis (AK) in the
United States,” she added.
Fourth Quarter Financial
Results
Total revenues were $9.2 million and $8.6
million for the three months ended December 31, 2021 and 2020,
respectively, an increase of $0.6 million, or 7%.
Total operating expenses were $11.0 million and
$8.8 million for the three months ended December 31, 2021 and 2020,
respectively. Cost of revenues increased by 8% primarily due to
higher sales of Ameluz®. Selling, general and administrative
expenses increased by $5.1 million compared with the prior year
primarily due to an increase in marketing expenses and
headcount.
Net loss was $14.5 million and $0.2 million for
the three months ended December 31, 2021 and 2020,
respectively.
Adjusted EBITDA was negative $3.2 million and
negative $3 thousand for the three months ended December 31, 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.
Full Year Financial Results
Total revenues were $24.1 million and $18.8
million for 2021 and 2020, respectively, an increase of $5.3
million, or 28%. The increase was primarily driven by a higher
volume of Ameluz® orders, which increased Ameluz® revenue by $4.1
million, and by an increase in the price of Ameluz®, which
increased Ameluz® revenue by $1.3 million.
Total operating expenses were $49.3 million and
$28.5 million for 2021 and 2020, respectively. Cost of revenues
increased by $3.7 million compared with the prior year primarily
due to higher sales of Ameluz®. Selling, general and administrative
expenses increased by $19.1 million compared with the prior year
primarily due to a one-time legal settlement expense, marketing
campaign expenses, increased headcount and higher commission
expenses related to improved sales performance.
Net loss was $37.7 million and $11.0 million for
the years ended December 31, 2021 and 2020, respectively.
Adjusted EBITDA was negative $12.7 million for
the year ended December 31, 2021 and was negative $9.2 million for
the year ended December 31, 2020.
The table below presents a reconciliation from
net loss to Adjusted EBITDA for the three and 12 months ended
December 31, 2021 and 2020:
|
|
Quarters ended December 31, |
|
|
Years endedDecember 31, |
|
|
2021 |
|
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Net income/(loss) |
|
$ |
(14,505 |
) |
|
|
$ |
(186 |
) |
|
$ |
(37,713 |
) |
|
$ |
(10,987 |
) |
Interest expense, net |
|
|
89 |
|
|
|
|
756 |
|
|
|
344 |
|
|
|
2,869 |
|
Income tax expenses |
|
|
5 |
|
|
|
|
(2 |
) |
|
|
56 |
|
|
|
64 |
|
Depreciation and amortization |
|
|
131 |
|
|
|
|
138 |
|
|
|
540 |
|
|
|
562 |
|
EBITDA |
|
|
(14,280 |
) |
|
|
|
706 |
|
|
|
(36,773 |
) |
|
|
(7,492 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of contingent consideration |
|
|
(3,100 |
) |
|
|
|
(98 |
) |
|
|
(1,402 |
) |
|
|
140 |
|
Change in fair value of warrant liabilities |
|
|
12,801 |
|
|
|
|
- |
|
|
|
12,801 |
|
|
|
- |
|
Cost reimbursement from Biofrontera Pharma GmbH |
|
|
- |
|
|
|
|
(312 |
) |
|
|
- |
|
|
|
(1,500 |
) |
Legal settlement expenses |
|
|
- |
|
|
|
|
- |
|
|
|
11,250 |
|
|
|
- |
|
Employee retention credit (“ERC”) |
|
|
- |
|
|
|
|
(299 |
) |
|
|
- |
|
|
|
(299 |
) |
Expensed issuance costs |
|
|
1,383 |
|
|
|
|
- |
|
|
|
1,383 |
|
|
|
- |
|
Adjusted EBITDA |
|
$ |
(3,196 |
) |
|
|
$ |
(3 |
) |
|
$ |
(12,741 |
) |
|
$ |
(9,151 |
) |
Adjusted EBITDA margin |
|
|
-34.9 |
% |
|
|
|
0.0 |
% |
|
|
-52.9 |
% |
|
|
-48.5 |
% |
Cash and cash equivalents as of December 31,
2021 were $24.5 million, compared with $8.1 million as of December
31, 2020. During 2021, Biofrontera received net proceeds of $41.8
million including $14.9 million from the sale of common stock in
its IPO, $13.6 million from a private placement and $13.2 million
from warrants exercised for its common stock. The Company believes
its cash and cash equivalents are sufficient to fund its operations
for at least the next 12 months.
Financial Guidance
Biofrontera today introduced financial guidance
for 2022, as follows:
- Total revenues are expected to
increase by at least 30% compared with 2021, including first
quarter total revenues up by over 100% versus the first quarter
prior year and typical seasonal strength in the first and fourth
quarters
- The commercial focus throughout
2022 will be on achieving deeper sales penetration among current
customer accounts, with additions to the Biofrontera sales force
expected to begin in 2023
Conference Call and Webcast
Biofrontera Inc. will hold a conference call
today at 11:00 a.m. Eastern time to discuss these results and
answer questions.
Date: |
|
Friday, April 8,
2022 |
Time: |
|
11:00 a.m. Eastern time |
Conference
Call: |
|
1-877-877-1275 (U.S.) |
|
|
1-412-858-5202
(international) |
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 PDT and topical antibiotics. The
Company’s licensed products are used for the treatment of actinic
keratoses, which are pre-cancerous skin lesions, as well as
impetigo, a bacterial skin infection. 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 Company’s business and marketing
strategy, future operations and business, future financial
position, potential to expand the label of Ameluz®, expected
revenue growth, expected cash flow for operations, expected total
revenues, projections constituting the financial guidance included
in this release and statements about the commercial focus of
Biofrontera Inc. throughout the year and expected increases in the
Company’s sales force. 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 ability of the
Company’s licensors to fulfill their obligations to the Company in
a timely manner; the Company’s ability to achieve and sustain
profitability; whether the current global disruptions in supply
chains 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 earlier clinical trials or trials of Ameluz® in
combination with BF-RhodoLED® in different disease indications or
product applications will be indicative of the results of ongoing
or future trials; 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; the
Company’s ability to complete the transition to a public company;
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.Anke zur
Mühlen+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 amounts)
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2021 |
|
|
2020 |
|
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
24,545 |
|
|
$ |
8,080 |
|
Accounts receivable, net |
|
|
3,784 |
|
|
|
3,216 |
|
Other receivables, related party |
|
|
8,647 |
|
|
|
73 |
|
Inventories |
|
|
4,458 |
|
|
|
7,091 |
|
Prepaid expenses and other current assets |
|
|
4,987 |
|
|
|
1,116 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
46,421 |
|
|
|
19,576 |
|
|
|
|
|
|
|
|
|
|
Other receivables long term, related party |
|
|
2,813 |
|
|
|
- |
|
Property and equipment, net |
|
|
267 |
|
|
|
370 |
|
Intangible asset, net |
|
|
3,450 |
|
|
|
3,869 |
|
Other assets |
|
|
268 |
|
|
|
323 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
53,219 |
|
|
$ |
24,138 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
658 |
|
|
$ |
176 |
|
Accounts payable, related parties |
|
|
282 |
|
|
|
1,538 |
|
Acquisition contract liabilities, net |
|
|
3,242 |
|
|
|
- |
|
Accrued expenses and other current liabilities |
|
|
9,654 |
|
|
|
2,706 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
13,836 |
|
|
|
4,420 |
|
|
|
|
|
|
|
|
|
|
Long-term liabilities: |
|
|
|
|
|
|
|
|
Acquisition contract liabilities, net |
|
|
9,542 |
|
|
|
13,828 |
|
Warrant liabilities |
|
|
12,854 |
|
|
|
- |
|
Other liabilities |
|
|
5,649 |
|
|
|
62 |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
$ |
41,881 |
|
|
$ |
18,310 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies (see Note 23) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common Stock, $0.001 par value, 300,000,000 shares authorized;
17,104,749 and 8,000,000 shares issued and outstanding as of
December 31, 2021 and 2020 |
|
$ |
17 |
|
|
$ |
8 |
|
Additional paid-in capital |
|
|
90,200 |
|
|
|
46,986 |
|
Accumulated deficit |
|
|
(78,879 |
) |
|
|
(41,166 |
) |
|
|
|
|
|
|
|
|
|
Total stockholders’ equity |
|
|
11,338 |
|
|
|
5,828 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity |
|
$ |
53,219 |
|
|
$ |
24,138 |
|
BIOFRONTERA
INC.STATEMENTS OF
OPERATIONS(In thousands, except
per share amounts and number of
shares)
|
|
|
|
|
|
|
|
Year Ending December 31, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
Products revenues, net |
|
$ |
24,043 |
|
|
|
$ |
18,787 |
|
Revenues, related party |
|
|
57 |
|
|
|
|
62 |
|
|
|
|
|
|
|
|
|
|
Total revenues, net |
|
|
24,100 |
|
|
|
|
18,849 |
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
Cost of revenues, related party |
|
|
12,222 |
|
|
|
|
8,313 |
|
Cost of revenues, other |
|
|
520 |
|
|
|
|
753 |
|
Selling, general and administrative |
|
|
36,512 |
|
|
|
|
17,706 |
|
Selling, general and administrative, related party |
|
|
697 |
|
|
|
|
411 |
|
Restructuring costs |
|
|
752 |
|
|
|
|
1,132 |
|
Change in fair value of contingent consideration |
|
|
(1,402 |
|
) |
|
|
140 |
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
49,301 |
|
|
|
|
28,455 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(25,201 |
|
) |
|
|
(9,606 |
) |
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
Change in fair value of warrant liabilities |
|
|
(12,801 |
) |
|
|
|
- |
|
Interest expense, net |
|
|
(344 |
|
) |
|
|
(2,869 |
) |
|
|
|
|
|
|
|
|
|
Other income, net |
|
|
689 |
|
|
|
|
1,552 |
|
|
|
|
|
|
|
|
|
|
Total other income (expense) |
|
|
(12,456 |
) |
|
|
|
(1,317 |
) |
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
|
(37,657 |
|
) |
|
|
(10,923 |
) |
Income tax expense |
|
|
56 |
|
|
|
|
64 |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(37,713 |
|
) |
|
$ |
(10,987 |
) |
|
|
|
|
|
|
|
|
|
Loss per common share: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(4.28 |
|
) |
|
$ |
(479.48 |
) |
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
8,808,233 |
|
|
|
|
22,915 |
|
# # #
BIOFRONTERA
INC.STATEMENTS OF
OPERATIONS(In thousands, except
per share amounts and number of
shares)
|
|
|
|
|
|
|
|
Quarters Ended December 31, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
|
Products revenues, net |
|
$ |
9,153 |
|
|
|
$ |
8,557 |
|
|
Revenues, related party |
|
|
15 |
|
|
|
|
15 |
|
|
|
|
|
|
|
|
|
|
|
Total revenues, net |
|
|
9,168 |
|
|
|
|
8,572 |
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
Cost of revenues, related party |
|
|
4,592 |
|
|
|
|
4,288 |
|
|
Cost of revenues, other |
|
|
181 |
|
|
|
|
135 |
|
|
Selling, general and administrative |
|
|
9,100 |
|
|
|
|
4,149 |
|
|
Selling, general and administrative, related party |
|
|
177 |
|
|
|
|
14 |
|
|
Restructuring costs |
|
|
98 |
|
|
|
|
272 |
|
|
Change in fair value of contingent consideration |
|
|
(3,100 |
|
) |
|
|
(98 |
) |
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
11,048 |
|
|
|
|
8,760 |
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(1,880 |
|
) |
|
|
(188 |
|
) |
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
Change in fair value of warrant liabilities |
|
|
(12,801 |
) |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net |
|
|
(89 |
|
) |
|
|
(756 |
|
) |
|
|
|
|
|
|
|
|
|
Other income, net |
|
|
270 |
|
|
|
|
756 |
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense) |
|
|
(12,620 |
) |
|
|
|
(0 |
|
) |
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
|
(14,500 |
|
) |
|
|
(188 |
|
) |
Income tax expense |
|
|
5 |
|
|
|
|
(2 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(14,505 |
|
) |
|
$ |
(186 |
|
) |
|
|
|
|
|
|
|
|
|
Loss per common share: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(1.29 |
|
) |
|
$ |
(2.12 |
|
) |
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
11,206,578 |
|
|
|
|
87,946 |
|
|
Biofrontera (NASDAQ:BFRIW)
Historical Stock Chart
From Jul 2024 to Aug 2024
Biofrontera (NASDAQ:BFRIW)
Historical Stock Chart
From Aug 2023 to Aug 2024