Aminolevulinic Acid Hydrochloride

Conference call begins at 10:00 a.m. Eastern time on Monday, March 18, 2024 WOBURN, MA / ACCESSWIRE / March 15, 2024 / Biofrontera AG, Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the commercialization of dermatological products, today reported financial results for the three and twelve months ended December 31, 2023. Highlights from 2023 and subsequent weeks include: Record total revenues of $34.1M reported for 2023, an increase of 19% over total revenues for 2022 of $28.7M. Total operating expenses for the year were $56.7 million compared with $47.3 million for 2022. Approximately, $2.0M of this increase was driven by one-time legal expenses. Achieved 4% increase in revenues for fourth quarter 2023 compared with 2022 despite more than doubling sales in third quarter. Restructured organization to align with business needs including expanding medical and reimbursement teams, contributing to 8% decrease in operating expenses for fourth quarter 2023 compared to 2022. Initiated a comprehensive strategic account strategy leading to deeper partnerships and multiple annual contracts. Submitted sNDA to increase maximum use to 3 tubes of Ameluz® in the treatment of actinic keratosis (AK) on the face and scalp with photodynamic therapy (PDT) using the RhodoLED® XL lamp with PDUFA date of October 4, 2024. Completed patient enrollment in Phase 3 clinical study evaluating Ameluz®-PDT with BF-RhodoLED® lamp for the treatment of superficial basal cell carcinoma (sBCC). Received approval from the FDA, through our partner Biofrontera Biosciences GmbH, for an improved formulation of Ameluz® without propylene glycol. Acquired patents and entered into an R&D agreement to develop a new, low-cost portable photodynamic therapy lamp for use with Ameluz®. Announced first patient dosing in Phase 3 multicenter clinical study of safety and efficacy of Ameluz® and RhodoLED® XL for treatment of AK on the extremities, neck and trunk. "I am pleased to announce 2023 was a record year for revenues," said Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera. "Our strategy as I took over as CEO in 2023 was to focus on holistic sales and marketing that included continuing to have a strong sales organization and strengthening our medical and reimbursement capabilities so we can provide dermatologists with the most effective support. Our sales growth reflects the strength and commitment of our organization and the partnerships we have. We have also made progress in key areas in the early part of 2024 to position ourselves for future success. The restructuring of our LSA agreement with our supplier, Biofrontera GmbH, to reduce the transfer price of Ameluz to 25% for 2024 and 2025 will allow us to manage our costs more closely, Transferring the management of US clinical trials in-house will lead to greater efficiency and efficacy of these activities, potentially leading to earlier FDA approvals for future indications. We also believe the cost improvements and reallocation of spend made over the last year will allow us to continue to grow while improving the value for our investors." "We had a strong 2023. We achieved a record high revenue number and sales volume, placed a record number of RhodoLED lamps, cleaned up our balance sheet, and continued to optimize our cost structure. The renegotiation of the LSA and securing of additional capital have been transformational events to our goal toward break even," added Fred Leffler, Chief Financial Officer of Biofrontera. Fourth Quarter Financial Results Total revenues for the fourth quarter of 2023 were $10.6 million, an increase of $0.5 million, or ~4%, compared with $10.1 million for the fourth quarter of 2022. This growth reflects the continued adoption of Ameluz but was impacted more than anticipated by strong buy-in prior to the price increase at the beginning of the quarter. Total operating expenses were $14.5 million for the fourth quarter of 2023 compared with $15.8 million for the fourth quarter of 2022. Cost of revenues was $5.4 million for the fourth quarter of 2023 compared with $5.3 million for the prior-year quarter, driven by higher Ameluz product revenue. Selling, general and administrative expenses were $9.1 million for the fourth quarter of 2023 compared with $10.2 million for the fourth quarter of 2022, with the decrease primarily driven by lower personnel costs. The net income for the fourth quarter of 2023 improved by $6.3 million to $3.5 million, or $1.65 per share, from a net loss of $2.8 million, or $(2.16) per share, for the prior-year quarter, with all per-share figures on a split-adjusted basis. Adjusted EBITDA for the fourth quarter of 2023 was negative $3.2 million compared with negative $4.4 million for the fourth quarter of 2022, reflecting higher revenues partially and decreased Selling, general, and administrative expenses. 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. We look at this customary metric to better assess and understand the performance of the business. Please refer to the table below for a reconciliation of GAAP to non-GAAP financial measures. Full Year Financial Results Total revenues for 2023 were $34.1 million compared with $28.7 million for 2022, an increase of approximately 19%, primarily driven by a higher volume of Ameluz sales and a higher average Ameluz selling price. Total operating expenses were $56.7 million for 2023 compared with $47.3 million for 2022. Cost of revenues increased to $17.4 million for 2023 from $15.2 million in 2022 primarily driven by increased Ameluz sales volume. Selling, general and administrative expenses for 2023 were $39.1 million compared with $35.9 million for 2022, an increase of about 9% compared with the prior year, primarily driven by personnel-related expenses and higher legal expenses. The net loss for 2023 was $20.1 million, or $(13.02) per diluted share, compared with a net loss of $0.6 million, or $(0.61) per share, for 2022. Adjusted EBITDA was negative $19.5 million for 2023 compared with negative $18.1 million for 2022. The decrease was primarily driven by the commercial team expansion that took place in the first quarter of 2023. Again, please refer to the table below for a reconciliation of GAAP to non-GAAP financial measures. Conference Call Details Conference call: Monday, March 18, 2024 at 10:00 AM ET Toll Free: 1-877-877-1275 (U.S. toll-free) International: 1-412-858-5202 Webcast: 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 and follow Biofrontera on LinkedIn and Twitter. Contacts Investor Relations Andrew Barwicki 1-516-662-9461 ir@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, as amended to date. These statements include, but are not limited to, statements relating to the Company's revenue guidance, 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, include, but are 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 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 Securities and Exchange Commission ("SEC"), which can be obtained on the SEC website at 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. (Tables follow) BIOFRONTERA INC. CONSOLIDATED BALANCE SHEETS (In thousands, except par value and share amounts) December 31, 2023 2022 ASSETS Current assets: Cash and cash equivalents $ 1,343 $ 17,208 Investment, related party 78 10,548 Accounts receivable, net 5,162 3,748 Other receivables, related party - 3,658 Inventories, net 10,908 7,168 Prepaid expenses and other current assets 425 810 Other assets, related party 5,159 - Total current assets 23,075 43,140 Other receivables long term, related party - 2,813 Property and equipment, net 134 204 Operating lease right-of-use assets 1,612 1,375 Intangible asset, net 2,629 3,032 Other assets 482 320 Total assets $ 27,932 $ 50,884 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable 3,308 1,278 Accounts payable, related parties, net 5,698 1,312 Accounts payable 5,698 1,312 Acquisition contract liabilities, net - 6,942 Operating lease liabilities 691 498 Accrued expenses and other current liabilities 4,487 10,864 Short term debt 3,904 - Total current liabilities 18,088 20,894 Long-term liabilities: Acquisition contract liabilities, net - 2,400 Warrant liabilities 4,210 2,843 Operating lease liabilities, non-current 804 848 Other liabilities 37 21 Total liabilities 23,139 27,006 Commitments and contingencies - - Stockholders' equity: Preferred Stock, $0.001 par value, 20,000,000 shares authorized, zero shares issued and outstanding as of December 31, 2023 and 2022 - - Common Stock, $0.001 par value, 15,000,000 shares authorized; 1,517,628 and 1,334,950 shares issued and outstanding as of December 31, 2023 and 2022 2 1 Additional paid-in capital 104,441 103,396 Accumulated deficit (99,650 ) (79,519 ) Total stockholders' equity 4,793 23,878 Total liabilities and stockholders' equity $ 27,932 $ 50,884 BIOFRONTERA INC. CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share amounts and number of shares) Three Months Ended December 31, For the Year Ended December 31, 2023 2022 2023 2022 Products revenues, net $ 10,582 10,074 $ 34,005 $ 28,541 Revenues, related party 13 70 66 133 Total revenues, net 10,595 10,144 34,071 28,674 Operating expenses Cost of revenues, related party 4,975 5,114 16,789 14,618 Cost of revenues, other 394 142 655 567 Selling, general and administrative 9,101 10,087 38,975 35,137 Selling, general and administrative, related party (41 ) 121 152 733 Research and development 33 - 77 - Change in fair value of contingent consideration - 300 100 (3,800 ) Total operating expenses 14,462 15,764 56,748 47,255 Loss from operations (3,867 ) (5,620 ) (22,677 ) (18,581 ) Other income (expense) Change in fair value of warrant liabilities 4,455 1,121 6,456 19,017 Warrant inducement expense (1,045 ) - (1,045 ) (2,629 ) Excess of warrant fair value over offering proceeds (2,272 ) - (2,272 ) - Change in fair value of investment, related party (786 ) 1,747 (7,421 ) 1,747 Gain on legal settlement 7,385 - 7,385 - Interest expense, net (211 ) (35 ) (468 ) (195 ) Other income (expense), net (140 ) 3 (75 ) 33 Total other income (expense) 7,386 2,836 2,560 17,973 Loss before income taxes 3,519 (2,784 ) (20,117 ) (608 ) Income tax expense (6 ) 1 14 32 Net income (loss) $ 3,525 (2,785 ) $ (20,131 ) $ (640 ) Income (loss) per common share: Basic and diluted $ 1.65 $ (2.13 ) $ (13.02 ) $ (0.61 ) Weighted-average common shares outstanding: Basic and diluted 2,140,400 1,290,467 1,546,297 1,056,988 BIOFRONTERA INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (In Thousands) Years ended December 31, 2023 2022 Cash Flows From Operating Activities: Net loss $ (20,131 ) $ (640 ) Adjustments to reconcile net loss to cash flows used in operations Gain on legal settlement (7,385 ) - Depreciation 86 101 Amortization of right-of-use assets 560 653 Amortization of acquired intangible assets 418 418 Change in fair value of investment, related party 7,421 (1,747 ) Change in fair value of contingent consideration 100 (3,800 ) Change in fair value of warrant liabilities (6,456 ) (19,017 ) Warrant inducement expense 1,045 2,629 Excess of warrant fair value over offering proceeds 2,272 - Stock-based compensation 1,045 1,852 Provision for inventory obsolescence - 100 Provision for doubtful accounts 122 106 Non-cash interest expense 402 358 Changes in operating assets and liabilities: Accounts receivable (1,536 ) (70 ) Other receivables, related party 6,470 4,990 Prepaid expenses and other assets 174 4,154 Other assets, related party (5,159 ) - Inventories (3,750 ) (2,810 ) Accounts payable and related party payables 6,415 912 Operating lease liabilities (657 ) (781 ) Accrued expenses and other liabilities (6,351 ) (3,607 ) Cash flows used in operating activities (24,895 ) (16,199 ) Cash flows from investing activities Purchases of investment, related party - (5,118 ) Sales of investment, related party 624 - Purchases of property and equipment (5 ) (38 ) Cash flows provided by (used in) investing activities 619 (5,156 ) Cash flows from financing activities Proceeds from line of credit 21,448 - Proceeds from short term debt 3,800 - Principal payments short term debt, net (21,344 ) Proceeds from issuance of common stock and warrants 4,507 9,391 Proceeds from exercise of warrants - 4,630 Cash flows provided by financing activities 8,411 14,021 Net decrease in cash and cash equivalents (15,865 ) (7,334 ) Cash, cash equivalents and restricted cash, at the beginning of the year 17,408 24,742 Cash, cash equivalents and restricted cash, at the end of the year $ 1,543 $ 17,408 Supplemental disclosure of cash flow information Interest paid $ 125 $ 1 Interest paid, related party $ 22 $ - Income tax paid, net $ 15 $ 32 Supplemental non-cash investing and financing activities Release of start-up cost financing obligation as part of legal settlement $ (7,300 ) $ - Release of contingent consideration obligation as part of legal settlement $ (2,500 ) $ - Transfer of investment as part of legal settlement $ 2,415 $ - Addition of right-of-use assets in exchange for operating lease liabilities $ 800 $ 234 Conversion of warrant liability to equity in connection with exercise of warrants $ - $ 6,840 Issuance of common shares in exchange for investment, related party $ - $ 3,683 BIOFRONTERA INC. ADJUSTED EBITDA (In thousands, except per share amounts and number of shares) Three months ended December 31, Twelve months ended December 31, 2023 2022 2023 2022 Net income (loss) $ 3,525 $ (2,785 ) $ (20,131 ) $ (640 ) Interest expense, net 212 35 468 195 Income tax expense (6 ) 1 14 32 Depreciation and amortization 125 126 504 519 EBITDA 3,856 (2,623 ) (19,145 ) 106 Gain on legal settlement (7,385 ) - (7,385 ) - Change in fair value of contingent consideration - 300 100 (3,800 ) Change in fair value of warrant liabilities (4,455 ) (1,121 ) (6,456 ) (19,017 ) Warrant inducement expense 1,045 - 1,045 2,629 Excess of warrant fair value of warrant liabilities 2,272 - 2,272 - Change in fair value of investment, related party 786 (1,747 ) 7,421 (1,747 ) Legal settlement expenses - 381 1,225 870 Stock-based compensation 228 383 1,045 1,852 Expensed issuance costs 422 - 422 1,045 Adjusted EBITDA $ (3,231 ) $ (4,427 ) $ (19,456 ) $ (18,062 ) Adjusted EBITDA margin -30.5 % -43.6 % -57.1 % -63.0 % # # # SOURCE: Biofrontera Inc. View the original press release on accesswire.com

LEXINGTON, KY / ACCESSWIRE / March 5, 2024 / NX Development Corp. (NXDC) has achieved another milestone as we proudly announce the recent granting of orphan-drug status by the U.S. Food and Drug Administration (FDA) for Gleolan (aminolevulinic acid HCl). This designation was provided for the "real-time detection and visualization of epithelial ovarian tumors during debulking surgery." NXDC Logo Logo of NXDC Dr. Salvatore DeSena, CEO of NX Development Corp., shared this excitement, stating, "On behalf of our entire team, I am proud to announce that NX Development Corp. secured orphan-drug status for Gleolan in ovarian, fallopian tube, and primary peritoneal cancer. This achievement demonstrates NXDC's commitment to exploring new and innovative uses for Gleolan to help patients and surgeons in their fight against these cancers." "This important milestone underlines the capabilities of aminolevulinic acid HCl in fluorescence-guided surgery. As a group, we aim to expand this further, also to other countries as well, providing support to patients and healthcare professionals combating cancer globally," said Dr. Ulrich Kosciessa, Chairman of the Board of NXDC and CEO of photonamic GmbH & Co KG. (Pinneberg, Germany), parent company to NXDC. Gleolan is an optical imaging agent indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery. Gleolan has gained clinical recognition for its use in visualizing malignant glioma tissue during surgery. About NX Development Corp.: NX Development Corp., a wholly-owned subsidiary of photonamic GmbH & Co. KG., a member of the SBI Holdings Inc. Group (Tokyo, Japan), is dedicated to revolutionizing cancer care through innovative solutions and groundbreaking developments in fluorescence-guided surgery. About Gleolan Contact Information Raquel R. adminpeopledept@nxdevcorp.com Alicia M. mediamarketing@nxdevcorp.com SOURCE: NX Development Corp. View the original press release on newswire.com.