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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(D)
OF
THE SECURITIES EXCHANGE ACT OF 1934
Date
of Report (Date of earliest event reported): August 11, 2023
Biofrontera
Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-40943 |
|
47-3765675 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
120
Presidential Way, Suite 330
Woburn,
Massachusetts |
|
01801 |
(Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (781) 245-1325
Not
Applicable
(Former
name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Exchange Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
stock, par value $0.001 per share |
|
BFRI |
|
The
Nasdaq Stock Market LLC |
|
|
|
|
|
Preferred
Stock Purchase Rights |
|
|
|
The
Nasdaq Stock Market LLC |
|
|
|
|
|
Warrants
to purchase common stock |
|
BFRIW |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (the “Exchange Act”) (§240.12b-2 of this chapter).
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On
August 11, 2023, Biofrontera Inc. (the “Company”) issued a press release announcing
its financial and operational results for the three and six months ended June 30, 2023. A copy of the press release is being furnished
as Exhibit 99.1 attached hereto to this Current Report on Form 8-K.
The
Company’s press release contains non-GAAP financial measures. Generally, a non-GAAP financial measure is a numerical measure of
a company’s performance, financial position, or cash flows that either excludes or includes amounts that are not normally excluded
or included in the most directly comparable measure calculated and presented in accordance with United States generally accepted accounting
principles, or GAAP. Pursuant to the requirements of Regulation G, the Company has provided within the press release quantitative reconciliations
of the non-GAAP financial measures to the most directly comparable GAAP financial measures.
The
information contained in this Item 2.02 in the Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is being furnished
and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), or otherwise subject to the liability of that section, nor shall such information be deemed to be incorporated by reference
in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly
set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
August
11, 2023 |
Biofrontera
Inc. |
(Date) |
(Registrant) |
|
|
|
/s/
E. Fred Leffler III |
|
E.
Fred Leffler, III |
|
Chief
Financial Officer |
Exhibit
99.1
Biofrontera
Inc. Reports Second Quarter 2023 Financial Results and Provides a Business Update
Conference
call begins at 8:30 a.m. Eastern time today
WOBURN,
Mass. (August 11, 2023) – 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, 2023
and provided a business update.
Highlights
from the second quarter of 2023 and subsequent weeks included the following:
| ● | Total
revenues were $5.8 million, an increase of 31% from the comparable prior-year period |
| ● | Cash
and cash equivalents were $4.5 million as of June 30, 2023, compared with $17.2 million as
of December 31, 2022 |
| ● | Equity
investment in shares of Biofrontera AG were $5.9 million as of June 30, 2023 |
| ● | Named
Founder and Executive Chairman Hermann Luebbert as Chief Executive Officer, who continues
to serve as Chairman of the Board of Directors |
| ● | Appointed
life sciences industry veteran Heikki Lanckriet, Ph.D. to the Board of Directors |
| ● | A
U.S. patent related to a novel photodynamic therapy (PDT) protocol that is expected to be
less painful but similarly effective to conventional PDT awarded to our licensing partner |
| ● | Engaged
a contract manufacturer to develop a new, low-cost portable PDT lamp for use with Ameluz®
(Ameluz-PDT) |
| ● | Announced
last patient out in a Phase 1 clinical study evaluating the safety and tolerability of treating
AK using three tubes of Ameluz |
| ● | Announced
last patient enrolled in Phase 3 clinical study evaluating Ameluz-PDT for the treatment of
superficial Basal Cell Carcinoma |
Management
Commentary
“Biofrontera
has always been a leader in innovation in PDT, and with advancements expected in multiple ongoing clinical studies for Ameluz, we are
positioned for significant market expansion and revenue potential. In addition to the recent progress in ongoing clinical studies, I
am proud of our team now beginning work on an early prototype of a portable PDT lamp, which has the potential not only to expand the
use of Ameluz-PDT to physician offices with space limitations, but also to provide our sales force with a new selling proposition that
can be easily transported and demonstrated to prospective customers,” said Hermann Luebbert, Chief Executive Officer and Chairman
of Biofrontera.
“With
enhancements to our commercial strategy that range from more impactful marketing to focusing investments in higher-value sales territories,
we are proud of our second quarter financial results as product revenues grew by 31% over the prior year,” added Fred Leffler,
Chief Financial Officer of Biofrontera Inc. “Our business is tracking well against our expectations and we are affirming guidance
for 2023 revenue growth of at least 25% compared with 2022.”
Second
Quarter Financial Results
Total
revenues for the second quarter of 2023 were $5.8 million, an increase of $1.4 million, or 31%, compared with $4.5 million for the second
quarter of 2022. This growth reflects higher sales of Ameluz due to a sales force expansion, increased adoption by dermatologists and
the absence of a buy-in impact due to a price increase.
Total
operating expenses were $14.5 million for the second quarter of 2023 compared with $10.7 million for the second quarter of 2022. Cost
of revenues was $2.9 million for the second quarter of 2023 compared with $2.6 million for the prior-year quarter, driven by higher
Ameluz product revenue. Selling, general and administrative expenses were $11.5 million for the second quarter of 2023 compared
with $10.0 million for the second quarter of 2022, with the increase primarily due to higher personnel costs, mostly related to severance
payments due to a realignment of the work force.
The
net loss for the second quarter of 2023 was $9.8 million, or $(7.23) per share, compared with a net loss of $850,000, or $(0.90) per
share, for the prior-year quarter, all on a post-split basis.
Adjusted
EBITDA for the second quarter of 2023 was negative $7.9 million compared with negative $7.1 million for the second quarter of 2022, reflecting
higher SG&A costs partially offset by increased revenues. 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 $14.6 million for the first half of 2023 compared with $14.2 million for the first half of 2022. The increase was primarily
driven by a higher volume of Ameluz sales due to the sales team expansion, a higher average Ameluz selling price and a higher volume
of RhodoLED® lamp sales. The increase is remarkable as it was achieved in the absence of the stocking effect of a price
increase as in the previous year.
Total
operating expenses were $28.8 million for the first half of 2023 compared with $23.5 million for the first half of 2022. Cost of revenues
decreased slightly from the prior year to $7.5 million for the first six months of 2023. Selling, general and administrative expenses
increased by 21 % compared with the prior year, primarily due to higher legal expenses and headcount.
The
net loss for the first half of 2023 was $17.3 million, or $(12.73) per share, compared with net income of $4.7 million, or $5.22 per
diluted share, for the first half of 2022.
Adjusted
EBITDA was negative $11.9 million for the first half of 2023 compared with negative $9.5 million for the first half of 2022.
The
below table presents a reconciliation from net income (loss) to Adjusted EBITDA for the three and six months ended June 30, 2023 and
2022:
| |
Three
months ended June
30, | | |
Six
months ended June
30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Net
income (loss) | |
$ | (9,837 | ) | |
$ | (850 | ) | |
$ | (17,315 | ) | |
$ | 4,711 | |
Interest
expense, net | |
| 79 | | |
| 38 | | |
| 114 | | |
| 71 | |
Income
tax expense | |
| 14 | | |
| - | | |
| 20 | | |
| 30 | |
Depreciation
and amortization | |
| 253 | | |
| 132 | | |
| 518 | | |
| 263 | |
EBITDA | |
| (9,491 | ) | |
| (680 | ) | |
| (16,663 | ) | |
| 5,075 | |
Change
in fair value of contingent consideration | |
| 100 | | |
| (1,900 | ) | |
| (100 | ) | |
| (1,900 | ) |
Change
in fair value of warrant liabilities | |
| (375 | ) | |
| (5,371 | ) | |
| (1,403 | ) | |
| (14,082 | ) |
Change
in fair value of investment, related party | |
| 1,482 | | |
| - | | |
| 4,424 | | |
| - | |
Legal
settlement expenses | |
| 107 | | |
| 261 | | |
| 1,225 | | |
| 313 | |
Stock
compensation expense | |
| 259 | | |
| 551 | | |
| 610 | | |
| 1,068 | |
Adjusted
EBITDA | |
$ | (7,918 | ) | |
$ | (7,139 | ) | |
$ | (11,907 | ) | |
$ | (9,526 | ) |
Adjusted
EBITDA margin | |
| -135.4 | % | |
| -160.2 | % | |
| -81.7 | % | |
| -67.0 | % |
As
of June 30, 2023, Biofrontera had cash and cash equivalents of $4.5 million compared with $17.2 million as of December 31, 2022. In addition,
the Company had a $5.9 million investment in shares of Biofrontera AG as of June 30, 2023.
Financial
Expectations
Biofrontera
Inc. affirms expectations for full-year 2023 growth in revenue to be at least 25% compared with 2022, and expects to be cash flow positive
within approximately one and a half years.
Conference
Call and Webcast
Biofrontera
Inc. will hold a conference call today at 8:30 a.m. Eastern time to discuss these results and answer questions.
|
Date: |
Friday,
August 11, 2023 |
|
Time: |
8:30
a.m. Eastern time |
|
Conference
Call: |
1-877-877-1275
(U.S. toll-free) |
|
|
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 dermatologic
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.
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
Biofrontera Inc.’s (the “Company”) 2023 revenue guidance, clinical trials for Ameluz® and potential
for label expansion, improved market opportunities, the potential impact of developing new PDT lamp prototypes and the impact of enhancements
to sales strategy. 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 any extraordinary external events; 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 comply with public company requirements; 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.
Contact:
LHA
Investor Relations
Tirth
T. Patel
212-201-6614
tpatel@lhai.com
(Tables
follow)
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands, except par value and share amounts)
| |
June
30, 2023 | | |
December
31, 2022 | |
| |
(Unaudited) | | |
| |
ASSETS | |
| | | |
| | |
Current
assets: | |
| | | |
| | |
Cash
and cash equivalents | |
$ | 4,453 | | |
$ | 17,208 | |
Investment,
related party | |
| 5,935 | | |
| 10,548 | |
Accounts
receivable, net | |
| 2,193 | | |
| 3,748 | |
Other
receivables, related party | |
| 4,001 | | |
| 3,658 | |
Inventories | |
| 14,785 | | |
| 7,168 | |
Prepaid
expenses and other current assets | |
| 929 | | |
| 810 | |
| |
| | | |
| | |
Total
current assets | |
| 32,296 | | |
| 43,140 | |
| |
| | | |
| | |
Other
receivables long term, related party | |
| - | | |
| 2,813 | |
Property
and equipment, net | |
| 175 | | |
| 204 | |
Operating
lease right-of-use assets | |
| 1,107 | | |
| 1,375 | |
Intangible
asset, net | |
| 2,823 | | |
| 3,032 | |
Other
assets | |
| 504 | | |
| 320 | |
| |
| | | |
| | |
Total
assets | |
$ | 36,905 | | |
$ | 50,884 | |
| |
| | | |
| | |
LIABILITIES
AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Current
liabilities: | |
| | | |
| | |
Accounts
payable | |
| 1,243 | | |
| 1,278 | |
Accounts
payable, related parties | |
| 4,657 | | |
| 1,312 | |
Acquisition
contract liabilities, net | |
| 7,121 | | |
| 6,942 | |
Operating
lease liabilities | |
| 489 | | |
| 498 | |
Accrued
expenses and other current liabilities | |
| 10,736 | | |
| 10,864 | |
Line
of credit | |
| 1,106 | | |
| - | |
| |
| | | |
| | |
Total
current liabilities | |
| 25,352 | | |
| 20,894 | |
| |
| | | |
| | |
Long-term
liabilities: | |
| | | |
| | |
Acquisition
contract liabilities, net | |
| 2,300 | | |
| 2,400 | |
Warrant
liabilities | |
| 1,440 | | |
| 2,843 | |
Operating
lease liabilities, non-current | |
| 600 | | |
| 848 | |
Other
liabilities | |
| 40 | | |
| 21 | |
| |
| | | |
| | |
Total
liabilities | |
| 29,732 | | |
| 27,006 | |
| |
| | | |
| | |
Commitments
and contingencies (Note 18) | |
| | | |
| | |
| |
| | | |
| | |
Stockholders’
equity: | |
| | | |
| | |
Preferred
Stock, $0.001 par value, 20,000,000 shares authorized, zero shares issued and outstanding as of June 30, 2023 and December 31, 2022 | |
| - | | |
| - | |
Common
Stock, $0.001 par value, 15,000,000 shares authorized; 1,367,628 and 1,359,040 shares issued and outstanding as of June 30, 2023
and December 31, 2022 | |
| 27 | | |
| 27 | |
Additional
paid-in capital | |
| 103,980 | | |
| 103,370 | |
Accumulated
deficit | |
| (96,834 | ) | |
| (79,519 | ) |
| |
| | | |
| | |
Total
stockholders’ equity | |
| 7,173 | | |
| 23,878 | |
| |
| | | |
| | |
Total
liabilities and stockholders’ equity | |
$ | 36,905 | | |
$ | 50,884 | |
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(In
thousands, except per share amounts and number of shares)
(Unaudited)
| |
Three
months ended June 30, | | |
Six
months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Product
revenues, net | |
$ | 5,830 | | |
$ | 4,441 | | |
$ | 14,544 | | |
$ | 14,177 | |
Revenues,
related party | |
| 18 | | |
| 16 | | |
| 36 | | |
| 31 | |
| |
| | | |
| | | |
| | | |
| | |
Total
revenues, net | |
| 5,848 | | |
| 4,457 | | |
| 14,580 | | |
| 14,208 | |
| |
| | | |
| | | |
| | | |
| | |
Operating
expenses | |
| | | |
| | | |
| | | |
| | |
Cost
of revenues, related party | |
| 2,772 | | |
| 2,402 | | |
| 7,319 | | |
| 7,377 | |
Cost
of revenues, other | |
| 116 | | |
| 152 | | |
| 167 | | |
| 327 | |
Selling,
general and administrative | |
| 11,456 | | |
| 9,669 | | |
| 21,254 | | |
| 17,285 | |
Selling,
general and administrative, related party | |
| 92 | | |
| 346 | | |
| 119 | | |
| 441 | |
Research
and development | |
| 11 | | |
| - | | |
| 11 | | |
| - | |
Change
in fair value of contingent consideration | |
| 100 | | |
| (1,900 | ) | |
| (100 | ) | |
| (1,900 | ) |
| |
| | | |
| | | |
| | | |
| | |
Total
operating expenses | |
| 14,547 | | |
| 10,669 | | |
| 28,770 | | |
| 23,530 | |
| |
| | | |
| | | |
| | | |
| | |
Loss
from operations | |
| (8,699 | ) | |
| (6,212 | ) | |
| (14,190 | ) | |
| (9,322 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other
income (expense) | |
| | | |
| | | |
| | | |
| | |
Change
in fair value of warrants | |
| 375 | | |
| 5,371 | | |
| 1,403 | | |
| 14,082 | |
Change
in fair value of investment, related party | |
| (1,482 | ) | |
| - | | |
| (4,424 | ) | |
| - | |
Interest
expense, net | |
| (79 | ) | |
| (38 | ) | |
| (114 | ) | |
| (71 | ) |
Other
income, net | |
| 62 | | |
| 29 | | |
| 30 | | |
| 52 | |
| |
| | | |
| | | |
| | | |
| | |
Total
other income (expense) | |
| (1,124 | ) | |
| 5,362 | | |
| (3,105 | ) | |
| 14,063 | |
| |
| | | |
| | | |
| | | |
| | |
Income
(loss) before income taxes | |
| (9,823 | ) | |
| (850 | ) | |
| (17,295 | ) | |
| 4,741 | |
Income
tax expense | |
| 14 | | |
| - | | |
| 20 | | |
| 30 | |
| |
| | | |
| | | |
| | | |
| | |
Net
income (loss) | |
$ | (9,837 | ) | |
$ | (850 | ) | |
$ | (17,315 | ) | |
$ | 4,711 | |
| |
| | | |
| | | |
| | | |
| | |
Income
(loss) per common share: | |
| | | |
| | | |
| | | |
| | |
Basic | |
$ | (7.23 | ) | |
$ | (0.90 | ) | |
$ | (12.73 | ) | |
$ | 5.24 | |
Diluted | |
$ | (7.23 | ) | |
$ | (0.90 | ) | |
$ | (12.73 | ) | |
$ | 5.22 | |
| |
| | | |
| | | |
| | | |
| | |
Weighted-average
common shares outstanding: | |
| | | |
| | | |
| | | |
| | |
Basic | |
| 1,360,739 | | |
| 941,175 | | |
| 1,359,894 | | |
| 898,444 | |
Diluted | |
| 1,360,739 | | |
| 941,175 | | |
| 1,359,894 | | |
| 902,209 | |
#
# #
v3.23.2
Cover
|
Aug. 11, 2023 |
Document Type |
8-K
|
Amendment Flag |
false
|
Document Period End Date |
Aug. 11, 2023
|
Entity File Number |
001-40943
|
Entity Registrant Name |
Biofrontera
Inc.
|
Entity Central Index Key |
0001858685
|
Entity Tax Identification Number |
47-3765675
|
Entity Incorporation, State or Country Code |
DE
|
Entity Address, Address Line One |
120
Presidential Way
|
Entity Address, Address Line Two |
Suite 330
|
Entity Address, City or Town |
Woburn
|
Entity Address, State or Province |
MA
|
Entity Address, Postal Zip Code |
01801
|
City Area Code |
(781)
|
Local Phone Number |
245-1325
|
Written Communications |
false
|
Soliciting Material |
false
|
Pre-commencement Tender Offer |
false
|
Pre-commencement Issuer Tender Offer |
false
|
Entity Emerging Growth Company |
true
|
Elected Not To Use the Extended Transition Period |
false
|
Entity Information, Former Legal or Registered Name |
Not
Applicable
|
Common stock, par value $0.001 per share |
|
Title of 12(b) Security |
Common
stock, par value $0.001 per share
|
Trading Symbol |
BFRI
|
Security Exchange Name |
NASDAQ
|
Preferred Stock Purchase Rights |
|
Title of 12(b) Security |
Preferred
Stock Purchase Rights
|
Security Exchange Name |
NASDAQ
|
Warrants to purchase common stock |
|
Title of 12(b) Security |
Warrants
to purchase common stock
|
Trading Symbol |
BFRIW
|
Security Exchange Name |
NASDAQ
|
X |
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