Biofrontera
Inc. (Nasdaq: BFRI),
a biopharmaceutical company specializing in the commercialization
of dermatological products, announced today financial results for
the three and six months ended June 30, 2022 and provided a
business update.
Financial Highlights & Recent
News
- Total revenues for the second
quarter of 2022 were $4.5 million, a decrease of 24% from the prior
year
- Total revenues for the first half
of 2022 were $14.2 million, an increase of 34% from the prior
year
- Cash and cash equivalents were
$31.9 million as of June 30, 2022, compared with $24.5 million as
of December 31, 2021
- Raised $8.7 million in net proceeds
through a private placement
- Subsequent to the quarter close,
raised approximately $4.3 million in net proceeds from the exercise
of existing warrants and issuance of new warrants through a private
placement
- Participated in The Benchmark
Healthcare House Call Virtual 1x1 Investor Conference
Clinical and Operational
Highlights
- Strengthened medical affairs
outreach through various initiatives including seminars, medical
conference participation, prescriber networking and key opinion
leader (KOL) engagement
- Showcased Biofrontera’s treatments
for actinic keratosis (AK) at the Music City Symposium for Cosmetic
Advances & Laser Education and debuted the new BF-RhodoLED® XL
illumination lamp via a live demonstration
- Launched new, 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
- Held education-focused initiatives
in recognition of May being Skin Cancer Awareness Month, including
participating in the Noah Worcester Dermatological Society
Conference and The Skin Cancer Foundation’s Champions for Change
Gala
- Presented newly published data and
forecasts for the U.S. skin cancer market that underscore the
commercial opportunity for Ameluz
- Named by CIOCoverage Magazine as
one of the “10 fastest-growing life sciences companies to watch in
2022”
- New Ameluz marketing campaign
earned a Gold 2022 Award of Excellence from The Communicator
Awards, a leading international industry-agnostic awards program
recognizing excellence in communication, championing effective and
meaningful work
- Biofrontera Pharma GmbH received
U.S. Food and Drug Administration (FDA) approval as a contract
laboratory for batch control and stability testing of Ameluz,
enabling significant improvements in product manufacturing
efficiency, quality control and supply reliability
- Biofrontera Bioscience GmbH was
granted a patent in Australia for novel illumination protocols
related to the treatment of skin diseases with photodynamic therapy
(PDT) that combine the lower pain of daylight PDT with the higher
cure rates and lower recurrence rates of conventional therapy.
Management Commentary
“I am duly proud of the accomplishments from
every aspect of our organization including medical education,
branding, marketing and sales, all of which contributed to another
successful quarter. The recognition we have received this year
demonstrates the positive impact of strengthening medical affairs
and establishing Biofrontera as a trusted partner to
dermatologists. Gaining PDT market share results from growing
therapeutic value, a key metric of our medical affairs initiative,
and our brands are being increasingly preferred by dermatologists,
patient advocacy groups and others as the leading therapeutic
option that continues to innovate and improve patient outcomes,”
stated Erica Monaco, Chief Executive Officer of Biofrontera
Inc.
“With revenues up 34% year-to-date, Biofrontera
had the strongest first-half revenues ever, up more than 102%
compared with 2020 and up more than 22% versus the pre-Covid year
2019. As expected, second quarter product revenues reflect the
April 1, 2022 price increase that resulted in some Ameluz purchase
pull-through into the first quarter. We continue to execute toward
upcoming clinical milestones and remain on track for 2022 total
revenues to increase by at least 30% compared with 2021, including
typical seasonal strength in the fourth quarter,” she added.
Second Quarter Financial
Results
Total revenues were $4.5 million for the second
quarter of 2022, a decrease of $1.4 million, or 24%, compared with
$5.9 million for the second quarter of 2021. The decrease was
primarily driven by lower Ameluz orders due to some advanced
purchasing prior to the April 1, 2022 price increase.
Total operating expenses were $10.7 million for
the second quarter of 2022, compared with $9.5 million for the
second quarter of 2021. Cost of revenues decreased by 18% primarily
due to lower Ameluz sales. Selling, general and administrative
expenses increased by $4.3 million, or 74%, compared with the prior
year primarily due to higher legal expenses, business insurance,
headcount and issuance costs related to the private placement.
Net loss for the second quarter of 2022 was $0.9
million, or $0.05 loss per share, compared with a net loss of $3.7
million, or $0.46 loss per share, for the second quarter of
2021.
Adjusted EBITDA was negative $8.0 million for
the second quarter of 2022, compared with negative $2.9 million for
the second quarter of 2021. Adjusted EBITDA, a non-GAAP financial
measure, is defined as net income or loss excluding interest income
and expense, income taxes, depreciation and amortization, and
certain other non-recurring or non-cash items.
Six Month Financial Results
Total revenues were $14.2 million for the first
half of 2022, an increase of $3.6 million, or 34%, compared with
$10.6 million for the first half of 2021. The increase was
primarily driven by a $3.5 million increase in Ameluz revenue,
along with a $0.1 million increase due to the Ameluz price
increase.
Total operating expenses were $23.5 million for
the first half of 2022, compared with $17.8 million for the first
half of 2021. Cost of revenues increased by 36% compared with the
prior-year period primarily due to higher sales of Ameluz. Selling,
general and administrative expenses increased by $7.1 million, or
66%, reflecting higher legal expenses, business insurance,
headcount and issuance costs related to the private placement.
Net income for the first half of 2022 was $4.7
million, or $0.26 per diluted share, compared with a net loss of
$7.2 million, or $0.90 loss per share, for the first half of
2021.
Adjusted EBITDA was negative $11.3 million for
the first half of 2022, compared with negative $5.7 million for the
first half of 2021.
The below table presents a reconciliation of net
income (loss) to adjusted EBITDA for the three and six months ended
June 30, 2022 and 2021:
|
|
Three months endedJune 30, |
|
|
Six months endedJune 30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Net income (loss) |
|
$ |
(850 |
) |
|
$ |
(3,661 |
) |
|
$ |
4,711 |
|
|
$ |
(7,195 |
) |
Interest expense, net |
|
|
38 |
|
|
|
85 |
|
|
|
71 |
|
|
|
169 |
|
Income tax expense |
|
|
- |
|
|
|
44 |
|
|
|
30 |
|
|
|
45 |
|
Depreciation and amortization |
|
|
132 |
|
|
|
138 |
|
|
|
263 |
|
|
|
275 |
|
EBITDA |
|
|
(680 |
) |
|
|
(3,394 |
) |
|
|
5,075 |
|
|
|
(6,706 |
) |
Change in fair value of contingent consideration |
|
|
(1,900 |
) |
|
|
500 |
|
|
|
(1,900 |
) |
|
|
998 |
|
Change in fair value of warrant liabilities |
|
|
(5,371 |
) |
|
|
- |
|
|
|
(14,082 |
) |
|
|
- |
|
Adjusted EBITDA |
|
$ |
(7,951 |
) |
|
$ |
(2,894 |
) |
|
$ |
(11,257 |
) |
|
$ |
(5,708 |
) |
Adjusted EBITDA margin |
|
|
-178.4 |
% |
|
|
-49.4 |
% |
|
|
-78.6 |
% |
|
|
-53.9 |
% |
As of June 30, 2022, Biofrontera Inc. had cash
and cash equivalents of $31.9 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 Inc. affirms its previously
announced financial guidance for 2022, as follows:
- Total revenues for 2022 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, August 12, 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
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 revenue guidance for 2022,
business and marketing strategy, future operations and business,
potential to expand the label of Ameluz®, market presence and
position of Ameluz® and ongoing clinical trials conducted by our
licensing partners and the future impact of such trials on the
market for Ameluz®. 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
BIOFRONTERA INC.BALANCE
SHEETS(In thousands, except par
value and share amounts)
|
|
June 30, 2022 |
|
|
December 31, 2021 |
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
31,913 |
|
|
$ |
24,545 |
|
Accounts receivable, net |
|
|
2,001 |
|
|
|
3,784 |
|
Other receivables, related party |
|
|
3,045 |
|
|
|
8,647 |
|
Inventories |
|
|
8,808 |
|
|
|
4,458 |
|
Prepaid expenses and other current assets |
|
|
1,214 |
|
|
|
4,987 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
46,981 |
|
|
|
46,421 |
|
|
|
|
|
|
|
|
|
|
Other receivables long term, related party |
|
|
2,813 |
|
|
|
2,813 |
|
Property and equipment, net |
|
|
248 |
|
|
|
267 |
|
Intangible asset, net |
|
|
3,241 |
|
|
|
3,450 |
|
Other assets |
|
|
343 |
|
|
|
268 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
53,626 |
|
|
$ |
53,219 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
931 |
|
|
$ |
658 |
|
Accounts payable, related parties |
|
|
1,290 |
|
|
|
282 |
|
Acquisition contract liabilities, net |
|
|
3,242 |
|
|
|
3,242 |
|
Accrued expenses and other current liabilities |
|
|
9,413 |
|
|
|
9,654 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
14,876 |
|
|
|
13,836 |
|
|
|
|
|
|
|
|
|
|
Long-term liabilities: |
|
|
|
|
|
|
|
|
Acquisition contract liabilities, net |
|
|
7,821 |
|
|
|
9,542 |
|
Warrant liability |
|
|
8,046 |
|
|
|
12,854 |
|
Other liabilities |
|
|
5,650 |
|
|
|
5,649 |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
$ |
36,393 |
|
|
$ |
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 June 30, 2022 and December
31, 2021 |
|
$ |
- |
|
|
$ |
- |
|
Common Stock, $0.001 par value, 300,000,000 shares authorized;
19,011,438 and 17,104,749 shares issued and outstanding as of June
30, 2022 and December 31, 2021 |
|
|
19 |
|
|
|
17 |
|
Additional paid-in capital |
|
|
91,382 |
|
|
|
90,200 |
|
Accumulated deficit |
|
|
(74,168 |
) |
|
|
(78,879 |
) |
|
|
|
|
|
|
|
|
|
Total stockholders’ equity |
|
|
17,233 |
|
|
|
11,338 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity |
|
$ |
53,626 |
|
|
$ |
53,219 |
|
BIOFRONTERA
INC.STATEMENTS OF
OPERATIONS(In thousands, except
per share amounts and number of
shares)(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
|
Six months ended June 30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Products revenues, net |
|
$ |
4,441 |
|
|
$ |
5,840 |
|
|
$ |
14,177 |
|
|
$ |
10,571 |
|
Revenues, related party |
|
|
16 |
|
|
|
15 |
|
|
|
31 |
|
|
|
28 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues, net |
|
|
4,457 |
|
|
|
5,855 |
|
|
|
14,208 |
|
|
|
10,599 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues, related party |
|
|
2,402 |
|
|
|
2,973 |
|
|
|
7,377 |
|
|
|
5,381 |
|
Cost of revenues, other |
|
|
152 |
|
|
|
135 |
|
|
|
327 |
|
|
|
298 |
|
Selling, general and administrative |
|
|
9,669 |
|
|
|
5,552 |
|
|
|
17,285 |
|
|
|
10,310 |
|
Selling, general and administrative, related party |
|
|
346 |
|
|
|
196 |
|
|
|
441 |
|
|
|
360 |
|
Restructuring costs |
|
|
- |
|
|
|
186 |
|
|
|
- |
|
|
|
467 |
|
Change in fair value of contingent consideration |
|
|
(1,900 |
) |
|
|
500 |
|
|
|
(1,900 |
) |
|
|
998 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
10,669 |
|
|
|
9,542 |
|
|
|
23,530 |
|
|
|
17,814 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(6,212 |
) |
|
|
(3,687 |
) |
|
|
(9,322 |
) |
|
|
(7,215 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of warrants |
|
|
5,371 |
|
|
|
- |
|
|
|
14,082 |
|
|
|
- |
|
Interest expense, net |
|
|
(38 |
) |
|
|
(85 |
) |
|
|
(71 |
) |
|
|
(169 |
) |
Other income, net |
|
|
29 |
|
|
|
155 |
|
|
|
52 |
|
|
|
234 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense) |
|
|
5,362 |
|
|
|
70 |
|
|
|
14,063 |
|
|
|
65 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
|
(850 |
) |
|
|
(3,617 |
) |
|
|
4,741 |
|
|
|
(7,150 |
) |
Income tax expense |
|
|
- |
|
|
|
44 |
|
|
|
30 |
|
|
|
45 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
(850 |
) |
|
$ |
(3,661 |
) |
|
$ |
4,711 |
|
|
$ |
(7,195 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.05 |
) |
|
$ |
(0.46 |
) |
|
$ |
0.26 |
|
|
$ |
(0.90 |
) |
Diluted |
|
$ |
(0.05 |
) |
|
$ |
(0.46 |
) |
|
$ |
0.26 |
|
|
$ |
(0.90 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
18,823,497 |
|
|
|
8,000,000 |
|
|
|
17,968,870 |
|
|
|
8,000,000 |
|
Diluted |
|
|
18,823,497 |
|
|
|
8,000,000 |
|
|
|
18,044,174 |
|
|
|
8,000,000 |
|
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