Biofrontera Inc. Reports First Quarter 2022 Financial Results and Provides a Business Update
May 13 2022 - 6:00AM
Biofrontera
Inc. (Nasdaq: BFRI)
(the “Company”)
, a biopharmaceutical company
specializing in the commercialization of dermatological products,
today announced financial results for the three months ended March
31, 2022, and provided a business update.
Financial Highlights
& Recent News
- Total revenues for the first
quarter of 2022 were $9.8 million, an increase of 106% from the
first quarter of 2021
- Cash and cash equivalents were
$22.4 million as of March 31, 2022, compared with $24.5 million as
of December 31, 2021
- Created a dedicated key accounts
team to address the changing landscape of the dermatology industry,
and advanced plans for a new model of inside sales support to
expand reach and frequency to newer and smaller accounts
- Received Orange Book listing for a
RhodoLED® XL lamp patent, providing Ameluz®-PDT with protection
from generic competition through October 2040
- Appointed Kevin Weber, a
pharmaceutical executive with more than 30 years of executive and
commercial experience, to the Company’s Board of Directors
- Patient recruitment by the
Company’s licensor continued for a Phase 3 study evaluating
Ameluz®-PDT for the treatment of basal cell carcinoma, a Phase 2
study evaluating Ameluz®-PDT in moderate-to-severe acne and a Phase
1 study evaluating three tubes of Ameluz® with the RhodoLED® XL
lamp in mild-to-severe actinic keratoses (AK) on the face and
scalp
- Participated in multiple academic
and industry conferences to strengthen the Company’s medical
affairs and educational initiatives
- Launched new and updated websites
for Ameluz® and Xepi®, each featuring a patient-focused and a
healthcare professional-focused site, at www.ameluz.com and
www.xepicream.com
Management Commentary
“During the first quarter our team maintained
the momentum we established late last year and achieved our
strongest revenue quarter since the beginning of the COVID-19
pandemic and our second-highest quarter on record. Further, March
2022 was our highest sales month on record, reflecting purchasing
ahead of an Ameluz® price increase and typical seasonal strength in
the first and fourth quarters. We continue to expect 2022 total
revenues to increase by at least 30% compared with 2021,” stated
Erica Monaco, Chief Executive Officer of Biofrontera Inc. “Our
market expansion strategy seeks optimization through deeper
penetration in our sales territories and high-value accounts,
strengthening medical affairs and becoming a trusted partner in
medical communities through scientific data publication, Key
Opinion Leader interaction and industry support. We made excellent
progress in all initiatives during the quarter.”
First Quarter Financial
Results
Total revenues were $9.8 million and $4.7
million for the first quarter of 2022 and 2021, respectively, an
increase of $5.0 million, or 106%. The increase was primarily
driven by a $4.6 million increase in Ameluz revenue, coupled with a
$0.4 million increase from price.
Total operating expenses were $12.9 million and
$8.3 million for the first quarter of 2022 and 2021, respectively.
Cost of revenues increased by 100% primarily due to higher sales of
Ameluz. Selling, general and administrative expenses increased by
$2.9 million compared with the prior year primarily due to higher
legal expenses, business insurance and headcount.
Net income of $5.6 million for the first quarter
of 2022 includes an $8.7 million decrease in the in fair value of
our warrant liabilities, and compares with a net loss of $3.5
million for the first quarter of 2021.
Adjusted EBITDA was negative $3.0 million for
the first quarter of 2022 compared with negative $2.8 million for
the first quarter of 2021. Adjusted EBITDA margin improved to
negative 30.3% from negative 59.3% a year ago. 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.
The below table presents a reconciliation from
net income (loss) to Adjusted EBITDA for the three months ended
March 31, 2022 and 2021:
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
2021 |
|
Net income/(loss) |
|
$ |
5,561 |
|
|
$ |
(3,534 |
) |
Interest expense, net |
|
|
33 |
|
|
|
84 |
|
Income tax expenses |
|
|
30 |
|
|
|
1 |
|
Depreciation and amortization |
|
|
131 |
|
|
|
138 |
|
EBITDA |
|
|
5,755 |
|
|
|
(3,311 |
) |
|
|
|
|
|
|
|
|
|
Change in fair value of contingent consideration |
|
|
- |
|
|
|
498 |
|
Change in fair value of warrant liabilities |
|
|
(8,711 |
) |
|
|
- |
|
Adjusted EBITDA |
|
$ |
(2,956 |
) |
|
$ |
(2,813 |
) |
Adjusted EBITDA margin |
|
|
-30.3 |
% |
|
|
-59.3 |
% |
As of March 31, 2022, Biofrontera had cash and
cash equivalents of $22.4 million, compared with $24.5 million as
of December 31, 2021. The Company believes its cash and cash
equivalents are sufficient to fund operations for at least the next
12 months.
Financial Guidance
Biofrontera maintains its previously announced
financial guidance for 2022, as follows:
- Total revenues are expected to
increase by at least 30% compared with 2021, including 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, May 13, 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 photodynamic therapy (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)BALANCE
SHEETS(In thousands, except par
value and share amounts)
|
|
March 31, 2022 |
|
|
December 31, 2021 |
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
22,428 |
|
|
$ |
24,545 |
|
Accounts receivable, net |
|
|
5,172 |
|
|
|
3,784 |
|
Other receivables, related party |
|
|
8,686 |
|
|
|
8,647 |
|
Inventories |
|
|
4,872 |
|
|
|
4,458 |
|
Prepaid expenses and other current assets |
|
|
1,373 |
|
|
|
4,987 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
42,531 |
|
|
|
46,421 |
|
|
|
|
|
|
|
|
|
|
Other receivables long term, related party |
|
|
2,813 |
|
|
|
2,813 |
|
Property and equipment, net |
|
|
245 |
|
|
|
267 |
|
Intangible asset, net |
|
|
3,345 |
|
|
|
3,450 |
|
Other assets |
|
|
268 |
|
|
|
268 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
49,202 |
|
|
$ |
53,219 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
302 |
|
|
$ |
658 |
|
Accounts payable, related parties |
|
|
269 |
|
|
|
282 |
|
Acquisition contract liabilities, net |
|
|
3,242 |
|
|
|
3,242 |
|
Accrued expenses and other current liabilities |
|
|
8,546 |
|
|
|
9,654 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
12,359 |
|
|
|
13,836 |
|
|
|
|
|
|
|
|
|
|
Long-term liabilities: |
|
|
|
|
|
|
|
|
Acquisition contract liabilities, net |
|
|
9,632 |
|
|
|
9,542 |
|
Warrant liability |
|
|
4,143 |
|
|
|
12,854 |
|
Other liabilities |
|
|
5,652 |
|
|
|
5,649 |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
$ |
31,786 |
|
|
$ |
41,881 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies (see Note 23) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Preferred Stock, $0.001 par value, 20,000,000 shares authorized,
zero shares issued and outstanding as of March 31, 2022 and
December 31, 2021 |
|
$ |
- |
|
|
$ |
- |
|
Common Stock, $0.001 par value, 300,000,000 shares authorized;
17,104,749 shares issued and outstanding as of March 31, 2022 and
December 31, 2021 |
|
|
17 |
|
|
|
17 |
|
Additional paid-in capital |
|
|
90,717 |
|
|
|
90,200 |
|
Accumulated deficit |
|
|
(73,318 |
) |
|
|
(78,879 |
) |
|
|
|
|
|
|
|
|
|
Total stockholders’ equity |
|
|
17,416 |
|
|
|
11,338 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity |
|
$ |
49,202 |
|
|
$ |
53,219 |
|
STATEMENTS OF
OPERATIONS(In thousands, except
per share amounts and number of
shares)(Unaudited)
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
Products revenues, net |
|
$ |
9,736 |
|
|
$ |
4,731 |
|
Revenues, related party |
|
|
15 |
|
|
|
13 |
|
|
|
|
|
|
|
|
|
|
Total revenues, net |
|
|
9,751 |
|
|
|
4,744 |
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
Cost of revenues, related party |
|
|
4,975 |
|
|
|
2,408 |
|
Cost of revenues, other |
|
|
175 |
|
|
|
163 |
|
Selling, general and administrative |
|
|
7,616 |
|
|
|
4,758 |
|
Selling, general and administrative, related party |
|
|
95 |
|
|
|
164 |
|
Restructuring costs |
|
|
- |
|
|
|
281 |
|
Change in fair value of contingent consideration |
|
|
- |
|
|
|
498 |
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
12,861 |
|
|
|
8,272 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(3,110 |
) |
|
|
(3,528 |
) |
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
Change in fair value of warrant liabilities |
|
|
8,711 |
|
|
|
- |
|
Interest expense, net |
|
|
(33 |
) |
|
|
(84 |
) |
Other income, net |
|
|
23 |
|
|
|
79 |
|
|
|
|
|
|
|
|
|
|
Total other income (expense) |
|
|
8,701 |
|
|
|
(5 |
) |
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
|
5,591 |
|
|
|
(3,533 |
) |
Income tax expense |
|
|
30 |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
5,561 |
|
|
$ |
(3,534 |
) |
|
|
|
|
|
|
|
|
|
Income (loss) per common share: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.33 |
|
|
$ |
(0.44 |
) |
Diluted |
|
$ |
0.32 |
|
|
$ |
(0.44 |
) |
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
|
Basic |
|
|
17,104,749 |
|
|
|
8,000,000 |
|
Diluted |
|
|
17,133,218 |
|
|
|
8,000,000 |
|
# # #
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