Full Press Release Details
Inc. Reports Fourth Quarter and
Full-year 2022 Financial Results
Mass. March 8, 2023 - Biofrontera, Inc. (NASDAQ:BFRI), a biopharmaceutical company specializing in the commercialization of
dermatological products, today announced financial results for the three and twelve months ended December 31, 2022.
| Record 2022 annual Ameluz revenues were 12% higher than previous record in pre-COVID 2019 | ||
| Grew share in our target market in 2022 by about 12% | ||
| Total revenues for the fourth quarter of 2022 grew 11% over the fourth quarter of 2021 | ||
| Total revenues for the year 2022 grew 19% over the year 2021 | ||
| Average revenue per sales rep grew approximately 20% over 2021 | ||
| Continued various education initiatives including seminars, medical conferences, prescriber networking and key opinion leader (KOL) engagement | ||
| Showcased our Ameluz therapy at three conference podiums including Fall Clinical, New Frontiers in Cosmetic Medicine & Medical Dermatology Symposium and Mount Sinai 25 th Winter Symposium | ||
| 4 Poster publications in a peer reviewed dermatology journal, SKIN The Journal of Cutaneous Medicine | ||
| Education initiatives included a 3-part webinar series for CME credit, a 3-part video series with over 1,200 views and 4-part podcast series with over 1,400 views | ||
| Ameluz new marketing campaign earned "Relaunch/Revitalization of the Year" and "Professional Website/Online Initiative of the Year" awards |
was a pivotal year for Biofrontera highlighted by our record annual Ameluz revenues, up 19% over 2021 and 12% higher than our
previous record in pre-COVID 2019," said Erica Monaco, Chief Executive Officer of Biofrontera Inc. "The company
continues to make a measurable impact in the AK marketplace in terms of both awareness and market share, and we are pleased that we
increased share in our target market by about 12%. We also completed much of the necessary investments to build out our commercial
infrastructure including broadening our sales effort and growing our medical affairs, marketing and education tools. I am proud of
what the Biofrontera team has accomplished in our first full year as a public company."
investments have created the necessary strong foundation upon which to execute our growth strategy," continued Ms. Monaco. "We
also believe there is a strong revenue growth potential with the current label for Ameluz -PDT as we improve our sales
coverage and continue to educate the market. Given our plans to expand our salesforce to 50-55 people over the next couple of years
plus continued salesforce productivity improvements, we expect to grow 2023 revenues by at least 25% over last year positioning us well
to be cashflow positive within approximately two years."
Quarter Financial Results
quarter 2022 total revenues of $10.1 million, compared with $9.2 million in the fourth quarter of 2021. The increase was driven by continued
growth in the sales of Ameluz, partially offset by shipping delays and some sales territory vacancies.
operating expenses were $15.8 million for the fourth quarter of 2022, compared with $11.0 million in the same period 2021. Cost of revenues
in the quarter increased by $483 thousand from the fourth quarter of 2021. The increase was primarily due to higher sales of Ameluz.
Selling, general and administrative expenses increased by $931 thousand over the fourth quarter of 2021 generally in line with the increase
loss for the fourth quarter of 2022 was $2.8 million compared with a net loss of $14.5 million for the fourth quarter of 2021.
EBITDA was negative $4.4 million for the fourth quarter of 2022, compared with negative $3.2 million for the fourth 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.
year 2022 Financial Results
revenues the full year of 2022 were $28.7 million, compared with $24.1 million for full year 2021. The increase was primarily driven
by higher volume of Ameluz orders as well as an Ameluz price increase, partially offset by shipping delays and some sales territory vacancies.
operating expenses were $47.3 million for the full year 2022, compared with $49.3 million for the same period in 2021. Cost of revenues
increased by $2.4 million compared with the prior-year period primarily due to higher sales of Ameluz. Selling, general and administrative
expenses decreased by $1.3 million from full year 2021. This decrease was driven by the one-time legal settlement expense of $11.3 million
recognized in 2021 offset by an increase in headcount costs as a result of resumed hiring in 2022 and a broad increase in the costs associated
with being a public company.
loss for full year of 2022 was $640 thousand compared with a net loss of $37.7 million for the full year 2021.
EBITDA was negative $18.1 million for the full year 2022, compared with negative $12.6 million for full year 2021.
2023 revenue growth of at least 25%
flow positive within approximately two years
company will no longer regularly provide preliminary, quarterly revenue results. Management believes that, while the data was helpful
during the first year as a public company, the revenue results will have more meaning when accompanied by the rest of the financial results
and additional context from management discussion. The company continue to provide complete financial results accompanied by a management
conference call at a normal quarterly cadence.
| Conference call: | Wednesday, March 8, 2023 at 4:30PM ET |
| Toll Free: | 888-506-0062 |
| International: | 973-528-0011 |
| Access Code: | 990014 |
| Webcast: | https://www.webcaster4.com/Webcast/Page/2948/47545 |
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.
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 Biofrontera Inc.'s (the "Company") revenue guidance for 2023, business and marketing strategy, revenue growth,
development and expansion of the Company's sales force and commercial infrastructure, sales force productivity, growth strategy,
liquidity and cash flow, potential to expand the label of Ameluz , available market opportunities for Ameluz , ongoing clinical
trials conducted by our licensing partners, and educational outreach efforts. 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 regain compliance with Nasdaq continued listing standards, 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.
thousands, except par value and share amounts)
| December 31, 2022 | December 31, 2021 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 17,208 | $ | 24,545 | ||||
| Investment in Equity Securities | 10,548 | - | ||||||
| Accounts receivable, net | 3,748 | 3,784 | ||||||
| Other receivables, related party | 3,658 | 8,647 | ||||||
| Inventories | 7,168 | 4,458 | ||||||
| Prepaid expenses and other current assets | 810 | 4,987 | ||||||
| Total current assets | 43,140 | 46,421 | ||||||
| Other receivables long term, related party | 2,813 | 2,813 | ||||||
| Property and equipment, net | 204 | 267 | ||||||
| Operating lease right-of-use assets | 1,375 | - | ||||||
| Intangible asset, net | 3,032 | 3,450 | ||||||
| Other assets | 320 | 268 | ||||||
| Total assets | $ | 50,884 | $ | 53,219 | ||||
| LIABILITIES AND STOCKHOLDER'S EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,278 | $ | 658 | ||||
| Accounts payable, related parties | 1,312 | 282 | ||||||
| Acquisition contract liabilities, net | 6,942 | 3,242 | ||||||
| Operating lease liability, current | 498 | - | ||||||
| Accrued expenses and other current liabilities | 10,864 | 9,654 | ||||||
| Total current liabilities | 20,894 | 13,836 | ||||||
| Long-term liabilities: | ||||||||
| Acquisition contract liabilities, net | 2,400 | 9,542 | ||||||
| Warrant liabilities | 2,843 | 12,854 | ||||||
| Operating lease liability, non-current | 848 | - | ||||||
| Other liabilities | 21 | 5,649 | ||||||
| Total liabilities | $ | 27,006 | $ | 41,881 | ||||
| Stockholders' equity: | ||||||||
| Preferred Stock, $0.001 par value, 20,000,000 shares authorized, zero shares issued and outstanding as of December 31, 2022 and 2021 | - | - | ||||||
| Common Stock, $0.001 par value, 300,000,000 shares authorized; 26,699,0002 and 17,104,749 shares issued and outstanding as of December 31, 2022 and 2021 | 27 | 17 | ||||||
| Additional paid-in capital | 103,370 | 90,200 | ||||||
| Accumulated deficit | (79,518 | ) | (78,879 | ) | ||||
| Total stockholders' equity | 23,878 | 11,338 | ||||||
| Total liabilities and stockholders' equity | $ | 50,884 | $ | 53,219 |
Statements of Operations
| Three Months Ended | For the Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Product revenues, net | $ | 10,074 | $ | 9,153 | $ | 28,541 | $ | 24,043 | ||||||||
| Revenues, related party | 70 | 15 | 133 | 57 | ||||||||||||
| Total revenues, net | 10,144 | 9,168 | 28,674 | 24,100 | ||||||||||||
| Operating expenses | ||||||||||||||||
| Cost of revenues, related party | 5,114 | 4,592 | 14,618 | 12,222 | ||||||||||||
| Cost of revenues, other | 142 | 181 | 567 | 520 | ||||||||||||
| Selling, general and administrative | 10,087 | 9,100 | 35,137 | 36,512 | ||||||||||||
| Selling, general and administrative, related party | 121 | 177 | 733 | 697 | ||||||||||||
| Restructuring costs | - | 98 | - | 752 | ||||||||||||
| Impairment loss | - | - | - | - | ||||||||||||
| Change in fair value of contingent consideration | 300 | (3,100 | ) | (3,800 | ) | (1,402 | ) | |||||||||
| Total operating expenses | 15,764 | 11,048 | 47,255 | 49,301 | ||||||||||||
| Loss from operations | (5,620 | ) | (1,880 | ) | (18,581 | ) | (25,201 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Change in fair value of warrant liabilities | 1,121 | (12,801 | ) | 16,388 | (12,801 | ) | ||||||||||
| Change in fair value of investments | 1,747 | - | 1,747 | - | ||||||||||||
| Interest expense, net | (35 | ) | (89 | ) | (195 | ) | (344 | ) | ||||||||
| Other income, net | 3 | 270 | 33 | 689 | ||||||||||||
| Total other income (expense) | 2,836 | (12,620 | ) | 17,973 | (12,456 | ) | ||||||||||
| Loss before income taxes | (2,784 | ) | (14,500 | ) | (608 | ) | (37,657 | ) | ||||||||
| Income tax expense | 1 | 5 | 32 | 56 | ||||||||||||
| Net income (loss) | $ | (2,785 | ) | $ | (14,505 | ) | $ | (640 | ) | $ | (37,713 | ) |
| For the Year Ended | ||||||||
| December 31, | ||||||||
| Cash flows from/(used in) operations | 2022 | 2021 | ||||||
| Net Loss | $ | (640 | ) | $ | (37,713 | ) | ||
| Adjustments to reconcile net loss to cash flow used in operations | ||||||||
| Depreciation | 101 | 122 | ||||||
| Amortization of right-of-use assets | 653 | - | ||||||
| Amortization of acquired intangible assets | 418 | 418 | ||||||
| Change in fair value of investment in equity securities | (1,747 | ) | - | |||||
| Change in fair value of contingent consideration | (3,800 | ) | (1,402 | ) | ||||
| Change in fair value of warrant liabilities | (16,388 | ) | 12,801 | |||||
| Stock-based compensation | 1,852 | 129 | ||||||
| Provision for inventory obsolescence | 100 | 33 | ||||||
| Provision for doubtful accounts | 106 | 44 | ||||||
| Non-cash interest expense | 358 | 358 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | $ | (70 | ) | $ | (612 | ) | ||
| Other receivables, related party | 4,990 | (11,387 | ) | |||||
| Prepaid expenses and other assets | 4,154 | (3,809 | ) | |||||
| Inventories | (2,810 | ) | 2,592 | |||||
| Accounts payable and related party payables | 912 | (773 | ) | |||||
| Operating lease liabilities | (781 | ) | - | |||||
| Accrued expenses and other liabilities | (3,607 | ) | 12,484 | |||||
| Cash flows used in operating activities | $ | (16,199 | ) | $ | (26,715 | ) | ||
| Cash flows from investing activities | ||||||||
| Purchases of property and equipment | (38 | ) | (11 | ) | ||||
| Purchase of investments in equity securities | (5,118 | ) | - | |||||
| Cash flows provided by investment activities | $ | (5,156 | ) | $ | (11 | ) | ||
| Cash flows from financing activities | ||||||||
| Proceeds from issuance of common stock upon initial public offering, net of issuance costs | - | 14,943 | ||||||
| Proceeds from issuance of common stock & warrants in private placement, net of issuance costs | 9,391 | 14,995 | ||||||
| Proceeds from exercise of warrants | 4,629 | 13,238 | ||||||
| Proceeds from exercise of pre-funded warrants | 1 | 15 | ||||||
| Cash flows provided by financing activities | $ | 14,021 | $ | 43,191 | ||||
| Net increase (decrease) in cash and cash equivalents | (7,334 | ) | 16,465 | |||||
| Cash, cash equivalents and restricted cash, at the beginning of the year | 24,742 | 8,277 | ||||||
| Cash, cash equivalents and restricted cash, at the end of the year | $ | 17,408 | $ | 24,742 |
EBITDA Reconciliation
| Three Months Ended Dec 31, | Twelve Months Ended Dec 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Net income/(loss) | $ | (2,785 | ) | (14,505 | ) | $ | (640 | ) | $ | (37,713 | ) | |||||
| Interest expense, net | 35 | 89 | 195 | 344 | ||||||||||||
| Income tax expenses | 1 | 5 | 32 | 56 | ||||||||||||
| Depreciation and amortization | 126 | 131 | 519 | 540 | ||||||||||||
| EBITDA | (2,623 | ) | (14,280 | ) | 106 | (36,773 | ) | |||||||||
| Change in fair value of contingent consideration | 300 | (3,100 | ) | (3,800 | ) | (1,402 | ) | |||||||||
| Change in fair value of warrant liabilities | (1,121 | ) | 12,801 | (16,388 | ) | 12,801 | ||||||||||
| Legal settlement expenses | 381 | - | 870 | 11,250 | ||||||||||||
| Expensed issuance costs | - | 1,383 | 1,045 | 1,383 | ||||||||||||
| Stock based compensation | 383 | - | 1,852 | 129 | ||||||||||||
| Change in FV of investments | (1,747 | ) | - | (1,747 | ) | - | ||||||||||
| Adjusted EBITDA | $ | (4,427 | ) | (3,196 | ) | $ | (18,062 | ) | (12,612 | ) | ||||||
| Adjusted EBITDA margin | -43.6 | % | -34.9 | % | -63.0 | % | -52.3 | % |