Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a
biopharmaceutical company specializing in the commercialization of
dermatologic products, today reported financial results for the
three and six months ended June 30, 2024 and provided a
business update.
Highlights from the second quarter of 2024 and
subsequent weeks included the following:
- Total revenues
for the second quarter of 2024 were $7.8 million, a 34%
increase from the same period of the prior year
- Cash and cash
equivalents were $4.4 million as of June 30, 2024,
compared with $1.3 million on December 31, 2023
- Biofrontera
announced the launch of a new, FDA-approved red-light source, the
RhodoLED® XL lamp in June and installed several lamps by June 30th,
2024
- Took control of
all clinical trials relating to Ameluz® in the US, allowing for
more effective cost management and direct oversight of trial
efficiency
- Biofrontera
raised an additional $8.0M in May 2024 from the exercise of
warrants and has since paid down all outstanding debt
Hermann Luebbert, Chief Executive Officer and
Chairman of Biofrontera Inc., stated, "This was a very
exciting period for us as we got our sales and marketing efforts in
full swing during the first half of the year. Additionally, on June
10th we launched the commercial distribution of the RhodoLED XL and
I am pleased to say that we shipped the first three machines within
1 week of launch. The RhodoLED XL is approved by the FDA in
combination with Ameluz®.”
“On June 1st, under the amended Ameluz License
and Supply Agreement, we took control of all clinical trials
relating to Ameluz® in the US, allowing direct interaction with
participating clinical centers. The reduced transfer price will
allow us to finance R&D activities and continue our commercial
growth trajectory, while reducing our overall costs,”
concluded Prof. Luebbert
Second Quarter Financial Results
Total revenues for the second quarter of 2024
were $7.8 million compared with $5.8
million for the second quarter of 2023. The increase is due in
part to a catch-up from lower sales in 1Q driven by reimbursement
challenges stemming from the Change Healthcare cyber security
event.
Total operating expenses were $12.9
million for the second quarter of 2024 compared
with $14.5 million for the second quarter of 2023. Cost
of revenues was $4.3 million for the second quarter of
2024 compared with $2.9 million for the prior-year
quarter, with the increase driven by increased sales. Selling,
general and administrative expenses were $7.9 million for
the second quarter of 2024 compared with $11.5
million for the second quarter of 2023. The decrease was
primarily driven by our continued effort to control cost and lower
legal expenses compared to the same period in 2023.
The net loss for the second quarter of 2024
was $257 thousand, compared with a net loss of $9.8
million, for the prior-year quarter. The decrease in the net loss
is attributed to lower selling, general, and administrative costs
as well as changes in non-cash P&L items including the fair
value of warrants and investments in related parties.
Adjusted EBITDA for the second quarter of 2024
was negative $4.7 million compared with
negative $7.9 million for the second quarter of 2023,
reflecting our lower selling, general, and administrative costs. We
look at Adjusted EBITDA, a non-GAAP financial measure, as a better
indication of ongoing operations and this measurement 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.
Please refer to the table below which presents a
GAAP to non- GAAP reconciliation of Adjusted EBITDA for the second
quarters of 2024 and 2023.
Six Month Financial Results
Total revenues were $15.8 million for the first
half of 2024 compared with $14.6 million for the first half of
2023. This 8.2% increase was primarily driven by continued
penetration of the photodynamic therapy and cryotherapy AK market
segments.
Total operating expenses were $26.3 million for
the first half of 2024 compared with $28.8 million for the first
half of 2023. Cost of revenues increased slightly from the prior
year to $8.5 million for the first six months of 2024 compared to
$7.5 million for the first half of 2023. Selling, general and
administrative expenses decreased to $17.2 million compared to
$21.4 million in the prior year. The decrease was primarily driven
by our continued effort to control cost and lower legal expenses
compared to the same period in 2023.The net loss for the first half
of 2024 was $10.7 million, compared with a net loss of $17.3
million for the first half of 2023.
Adjusted EBITDA was negative $9.3 million for
the first half of 2024 compared with negative $11.9 million for the
first half of 2023.
Conference Call Details
Conference call: Thursday, August 15,
2024 at 10:00 AM ET Toll Free: 1-877-877-1275
(U.S. toll-free)International: 1-412-858-5202Webcast:
https://event.choruscall.com/mediaframe/webcast.html?webcastid=bU2HFqrt
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 and follow
Biofrontera on LinkedIn and Twitter.
Contacts Investor RelationsAndrew
Barwicki1-516-662-9461ir@bfri.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.
These statements include, but are not limited to, statements
relating to the Company's revenue guidance, business and marketing
strategy, revenue growth, sales force productivity, growth
strategy, liquidity and cash flow, potential to expand the label of
Ameluz®, available market opportunities for Ameluz®, ongoing
clinical trials, educational outreach efforts, and other statements
that are not historical facts. The words "intends," "may," "will,"
"plans," "expects," "anticipates," "projects," "predicts,"
"estimates," "aims," "believes," "hopes," "potential", "target",
"goal", "assume", "would", "could" or similar words are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words. 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, include, but are not limited to, our
reliance on sales of products we license from other companies as
our sole source of revenue; the success of our competitors in
developing generic topical dermatological products that
successfully compete with our licensed products; the success of our
principal licensed product, Ameluz®; the ability of the Company's
licensors to establish and maintain relationships with contract
manufacturers that are able to supply the Company with enough of
the licensed products to meet our demand; the ability of our
licensors or their manufacturing partners to supply the licensed
products that we market in sufficient quantities and at acceptable
quality and cost levels, and to fully comply with current good
manufacturing practice or other applicable manufacturing
regulations; the ability of our licensors to successfully defend or
enforce patents related to our licensed products; the availability
of insurance coverage and medical expense reimbursement for our
licensed products; the impact of legislative and regulatory
changes; competition from other pharmaceutical and medical device
companies and existing treatments, such as simple curettage and
cryotherapy; the Company's ability to achieve and sustain
profitability; the Company's ability to obtain additional financing
as needed to implement its growth strategy; the Company's ability
to retain and hire key personnel; and other factors that may be
disclosed in the Company's filings with the Securities and
Exchange Commission ("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 undertake 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.
(Tables follow)
BIOFRONTERA
INC.CONDENSED CONSOLIDATED BALANCE
SHEETS(In thousands, except par
value and share amounts)
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
|
|
(Unaudited) |
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
4,379 |
|
|
$ |
1,343 |
|
Investment, related party |
|
|
10 |
|
|
|
78 |
|
Accounts receivable, net |
|
|
3,504 |
|
|
|
5,162 |
|
Inventories, net |
|
|
3,946 |
|
|
|
10,908 |
|
Prepaid expenses and other current assets |
|
|
473 |
|
|
|
425 |
|
Other assets, related party |
|
|
5,159 |
|
|
|
5,159 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
17,471 |
|
|
|
23,075 |
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
101 |
|
|
|
134 |
|
Operating lease right-of-use assets |
|
|
1,230 |
|
|
|
1,612 |
|
Intangible asset, net |
|
|
2,448 |
|
|
|
2,629 |
|
Other assets |
|
|
324 |
|
|
|
482 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
21,574 |
|
|
$ |
27,932 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
|
2,413 |
|
|
|
3,308 |
|
Accounts payable, related parties |
|
|
2,265 |
|
|
|
5,698 |
|
Operating lease liabilities |
|
|
701 |
|
|
|
691 |
|
Accrued expenses and other current liabilities |
|
|
3,593 |
|
|
|
4,487 |
|
Short term debt |
|
|
296 |
|
|
|
3,904 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
9,268 |
|
|
|
18,088 |
|
|
|
|
|
|
|
|
|
|
Long-term liabilities: |
|
|
|
|
|
|
|
|
Warrant liabilities |
|
|
921 |
|
|
|
4,210 |
|
Operating lease liabilities, non-current |
|
|
443 |
|
|
|
804 |
|
Other liabilities |
|
|
31 |
|
|
|
37 |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
10,663 |
|
|
|
23,139 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Series B Convertible Preferred stock, $0.001 par value,
20,000,000 shares authorized, no Series B-1, 4,806 Series B-2 and
7,998 Series B-3 shares issued and outstanding as of June 30, 2024
and no shares issued and outstanding as of December 31, 2023 |
|
|
- |
|
|
|
- |
|
Common stock, $0.001 par value, 35,000,000 shares authorized;
5,094,184 and 1,517,628 shares issued and outstanding as of June
30, 2024 and December 31, 2023, respectively |
|
|
5 |
|
|
|
2 |
|
Additional paid-in capital |
|
|
121,250 |
|
|
|
104,441 |
|
Accumulated deficit |
|
|
(110,344 |
) |
|
|
(99,650 |
) |
|
|
|
|
|
|
|
|
|
Total stockholders’ equity |
|
|
10,911 |
|
|
|
4,793 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity |
|
$ |
21,574 |
|
|
$ |
27,932 |
|
BIOFRONTERA
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(In thousands, except
per share amounts and number of
shares)(Unaudited)
|
|
Three Months EndedJune 30, |
|
|
Six Months EndedJune 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues, net |
|
$ |
7,831 |
|
|
$ |
5,830 |
|
|
$ |
15,732 |
|
|
$ |
14,544 |
|
Revenues, related party |
|
|
8 |
|
|
|
18 |
|
|
|
18 |
|
|
|
36 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues,
net |
|
|
7,839 |
|
|
|
5,848 |
|
|
|
15,750 |
|
|
|
14,580 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues, related
party |
|
|
4,092 |
|
|
|
2,772 |
|
|
|
8,038 |
|
|
|
7,319 |
|
Cost of revenues, other |
|
|
250 |
|
|
|
116 |
|
|
|
421 |
|
|
|
167 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative |
|
|
7,915 |
|
|
|
11,456 |
|
|
|
17,163 |
|
|
|
21,254 |
|
Selling, general and
administrative, related party |
|
|
32 |
|
|
|
92 |
|
|
|
29 |
|
|
|
119 |
|
Research and development |
|
|
621 |
|
|
|
11 |
|
|
|
637 |
|
|
|
11 |
|
Change in fair value of
contingent consideration |
|
|
- |
|
|
|
100 |
|
|
|
- |
|
|
|
(100 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses |
|
|
12,910 |
|
|
|
14,547 |
|
|
|
26,288 |
|
|
|
28,770 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(5,071 |
) |
|
|
(8,699 |
) |
|
|
(10,538 |
) |
|
|
(14,190 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of
warrants |
|
|
5,438 |
|
|
|
375 |
|
|
|
2,009 |
|
|
|
1,403 |
|
Change in fair value of
investment, related party |
|
|
(14 |
) |
|
|
(1,482 |
) |
|
|
(11 |
) |
|
|
(4,424 |
) |
Loss on debt
extinguishment |
|
|
- |
|
|
|
- |
|
|
|
(316 |
) |
|
|
- |
|
Interest expense, net |
|
|
(596 |
) |
|
|
(79 |
) |
|
|
(2,003 |
) |
|
|
(114 |
) |
Other income, net |
|
|
6 |
|
|
|
62 |
|
|
|
186 |
|
|
|
30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income
(expense) |
|
|
4,834 |
|
|
|
(1,124 |
) |
|
|
(135 |
) |
|
|
(3,105 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income
taxes |
|
|
(237 |
) |
|
|
(9,823 |
) |
|
|
(10,673 |
) |
|
|
(17,295 |
) |
Income tax expense |
|
|
20 |
|
|
|
14 |
|
|
|
21 |
|
|
|
20 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(257 |
) |
|
$ |
(9,837 |
) |
|
$ |
(10,694 |
) |
|
$ |
(17,315 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per common
share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.05 |
) |
|
$ |
(7.23 |
) |
|
$ |
(2.45 |
) |
|
$ |
(12.73 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
common shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
5,091,353 |
|
|
|
1,360,739 |
|
|
|
4,357,474 |
|
|
|
1,359,894 |
|
BIOFRONTERA INC.GAAP TO
NON-GAAP ADJUSTED EBITDA
RECONCILIAITION(In thousands,
except per share amounts and number of
shares)(Unaudited)
|
|
Three Months EndedJune 30, |
|
|
Six Months EndedJune 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Net loss |
|
$ |
(257 |
) |
|
$ |
(9,837 |
) |
|
$ |
(10,694 |
) |
|
$ |
(17,315 |
) |
Interest expense, net |
|
|
596 |
|
|
|
79 |
|
|
|
2,003 |
|
|
|
114 |
|
Income tax expenses |
|
|
20 |
|
|
|
14 |
|
|
|
21 |
|
|
|
20 |
|
Depreciation and
amortization |
|
|
130 |
|
|
|
253 |
|
|
|
258 |
|
|
|
518 |
|
EBITDA |
|
|
489 |
|
|
|
(9,491 |
) |
|
|
(8,412 |
) |
|
|
(16,663 |
) |
Loss on debt
extinguishment |
|
|
- |
|
|
|
- |
|
|
|
316 |
|
|
|
- |
|
Change in fair value of
contingent consideration |
|
|
- |
|
|
|
100 |
|
|
|
- |
|
|
|
(100 |
) |
Change in fair value of
warrant liabilities |
|
|
(5,438 |
) |
|
|
(375 |
) |
|
|
(2,009 |
) |
|
|
(1,403 |
) |
Change in fair value of
investment, related party |
|
|
14 |
|
|
|
1,482 |
|
|
|
11 |
|
|
|
4,424 |
|
Legal settlement expenses |
|
|
- |
|
|
|
107 |
|
|
|
- |
|
|
|
1,225 |
|
Stock based compensation |
|
|
204 |
|
|
|
259 |
|
|
|
432 |
|
|
|
610 |
|
Expensed issuance costs |
|
|
- |
|
|
|
- |
|
|
|
354 |
|
|
|
- |
|
Adjusted
EBITDA |
|
$ |
(4,731 |
) |
|
$ |
(7,918 |
) |
|
$ |
(9,308 |
) |
|
$ |
(11,907 |
) |
Adjusted EBITDA
margin |
|
|
-60.3 |
% |
|
|
-135.4 |
% |
|
|
-59.1 |
% |
|
|
-81.7 |
% |
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