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Conference call begins at 11:00 a.m. Eastern time today
WOBURN, Mass., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, today announced financial results for the three and nine months ended September 30, 2022 and provided a business update.
Highlights from the third quarter of 2022 and subsequent weeks include the following:
Financial Highlights
Clinical and Business Highlights
Management Commentary
“During the third quarter and recent weeks we strengthened our medical affairs initiatives with sponsorship, participation and presentation of our innovative dermatology solutions. Through peer-to-peer interactions and other activities, dermatologists are increasingly choosing our brands for their patients. The variety of our activities and our visibility in the dermatology sector are sharpening our corporate profile as an innovative dermatology company and emphasizing our strong commitment to improving patient care in collaboration with dermatologists. Our success in strengthening patent protection for our products justifies continued investments in marketing and further clinical development,” stated Erica Monaco, Chief Executive Officer of Biofrontera Inc. “Key strategic hires including a CFO and a national sales director will support our continued success. With year-to-date revenues up 24%, we expect total revenues for 2022 to increase between 24% and 31% compared with 2021, inclusive of seasonal strength in the first and fourth quarters. We expect to close 2022 with demonstrated market-share gains as well as with an operational foundation that will position us for increased ROI in 2023.”
Third Quarter Financial Results
Total revenues for the third quarter of 2022 of $4.3 million were consistent with the third quarter of 2021.
Total operating expenses were $8.0 million for the third quarter of 2022, compared with $20.4 million for the third quarter of 2021. Cost of revenues decreased by 3% primarily due to lower Ameluz sales. Selling, general and administrative expenses decreased by $9.3 million, or 54%, compared with the prior year primarily due to a one-time legal settlement expense in 2021, partially offset by higher business insurance and headcount costs as a result of resumed hiring in 2022.
Net loss for the third quarter of 2022 was $2.6 million, or $0.11 per share, compared with a net loss of $16.0 million, or $2.00 per share, for the third quarter of 2021.
Adjusted EBITDA was negative $5.0 million for the third quarter of 2022, compared with negative $3.8 million for the third 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.
Nine Month Financial Results
Total revenues for the first nine months of 2022 were $18.5 million, compared with $14.9 million for the first nine months of 2021. The increase of $3.6 million, or 24%, was primarily driven by higher volume of Ameluz orders, which resulted in an increase in Ameluz revenue of $3.2 million, and by an Ameluz price increase, which increased Ameluz revenue by $0.2 million.
Total operating expenses were $31.5 million for the first nine months of 2022, compared with $38.3 million for the same period in 2021. Cost of revenues increased by 25% compared with the prior-year period primarily due to higher sales of Ameluz. Selling, general and administrative expenses decreased by $2.3 million, or 8%, primarily due to a one-time legal settlement expense in 2021, partially offset by higher business insurance and headcount costs as a result of resumed hiring in 2022.
Net income for the first nine months of 2022 was $2.1 million, or $0.11 per diluted share, compared with net loss of $23.2 million, or $2.90 per share, for the first nine months of 2021.
Adjusted EBITDA was negative $14.1 million for the first nine months of 2022, compared with negative $9.5 million for the same period in 2021.
The below table presents a reconciliation of net income (loss) to adjusted EBITDA for the three and nine months ended September 30, 2022 and 2021: Three months ended
September 30, Nine months ended
September 30, 2022 2021 2022 2021 Net income (loss) $(2,566) $(16,012) $2,145 $(23,208)Interest expense, net 89 86 160 255 Income tax expense 1 6 31 51 Depreciation and amortization 130 134 394 409 EBITDA (2,346) (15,786) 2,730 (22,493)Change in fair value of contingent consideration (2,200) 700 (4,100) 1,698 Change in fair value of warrant liabilities (1,185) - (15,267) - Legal settlement expenses - 11,250 - 11,250 Stock-based compensation 400 - 1,469 - Expensed issuance costs 320 - 1,045 - Adjusted EBITDA $(5,011) $(3,836) $(14,123) $(9,545)Adjusted EBITDA margin -115.9% -88.5% -76.2% -63.9%
As of September 30, 2022, Biofrontera Inc. had cash and cash equivalents of $27.5 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. is revising its previously announced financial guidance for 2022, as follows:
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:Monday, November 14, 2022Time:11:00 a.m. Eastern timeConference call: 877-877-1275 (U.S.)
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 Biofrontera Inc.’s (the “Company”) revenue guidance for 2022, the Company’s relationship with Biofrontera AG (including beneficial ownership of Biofrontera AG’s shares and future collaboration between the Company and Biofrontera AG), business and marketing strategy, hiring strategy, development of medical affairs initiatives, growth of the Company’s profile, future operations and business, increased patent protection for our licensed products, 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 1539
us-ir@biofrontera.com
LHA Investor Relations
Tirth T. Patel
+1 212 201 6614
tpatel@lhai.com
BIOFRONTERA INC.
CONSOLIDATED BALANCE SHEETS
( In thousands, except par value and share amounts ) September 30, 2022 December 31, 2021 (Unaudited) ASSETS Current assets: Cash and cash equivalents $27,518 $24,545 Accounts receivable, net 1,562 3,784 Other receivables, related party 3,503 8,647 Inventories 12,087 4,458 Prepaid expenses and other current assets 3,823 4,987 Total current assets 48,493 46,421 Other receivables long term, related party 2,813 2,813 Property and equipment, net 224 267 Intangible asset, net 3,136 3,450 Other assets 393 268 Total assets $55,059 $53,219 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $253 $658 Accounts payable, related parties 4,206 282 Acquisition contract liabilities, net 3,242 3,242 Accrued expenses and other current liabilities 9,442 9,654 Total current liabilities 17,143 13,836 Long-term liabilities: Acquisition contract liabilities, net 5,711 9,542 Warrant liability 3,964 12,854 Other liabilities 5,646 5,649 Total liabilities $32,464 $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 September 30, 2022, and December 31, 2021 $- $- Common Stock, $0.001 par value, 300,000,000 shares authorized; 23,550,960 and 17,104,749 shares issued and outstanding as of September 30, 2022, and December 31, 2021 23 17 Additional paid-in capital 99,306 90,200 Accumulated deficit (76,734) (78,879) Total stockholders’ equity 22,595 11,338 Total liabilities and stockholders’ equity $55,059 $53,219
BIOFRONTERA INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
( In thousands, except per share amounts and number of shares )
(Unaudited) Three months ended
September 30, Nine months ended
September 30, 2022 2021 2022 2021 Products revenues, net $4,290 $4,319 $18,467 $14,890 Revenues, related party 32 15 63 42 Total revenues, net 4,322 4,334 18,530 14,932 Operating expenses Cost of revenues, related party 2,127 2,249 9,504 7,630 Cost of revenues, other 98 41 425 339 Selling, general and administrative 7,765 17,090 25,050 27,412 Selling, general and administrative, related party 171 160 612 520 Restructuring costs - 199 - 654 Change in fair value of contingent consideration (2,200) 700 (4,100) 1,698 Total operating expenses 7,961 20,439 31,491 38,253 Loss from operations (3,639) (16,105) (12,961) (23,321) Other income (expense) Change in fair value of warrants 1,185 - 15,267 - Interest expense, net (89) (86) (160) (255)Other income (expense), net (22) 185 30 419 Total other income (expense) 1,074 99 15,137 164 Income (loss) before income taxes (2,566) (16,006) 2,176 (23,157)Income tax expense 1 6 31 51 Net income (loss) $(2,566) $(16,012) $2,145 $(23,208) Income (loss) per common share: Basic $(0.11) $(2.00) $0.11 $(2.90)Diluted $(0.11) $(2.00) $0.11 $(2.90) Weighted-average common shares outstanding: Basic 22,725,821 8,000,000 19,560,351 8,000,000 Diluted 22,725,821 8,000,000 19,605,014 8,000,000
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