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Third Quarter Financial Results

Total revenues for the third quarter of 2024 were $9.0 million compared with $8.9 million for the third quarter of 2023. This increase was driven by a $0.6 million increase from sales of devices, offset by a net decrease in sales of Ameluz of $0.5 million. The decline in Ameluz unit sales resulted from the delayed delivery of 4,640 units in October 2024, as Hurricane Milton caused office closures and shipping delays across the Southeast.
Total operating expenses were $14.0 million for the third quarter of 2024 compared with $13.5 million for the third quarter of 2023. Cost of revenues was $4.9 million for the third quarter of 2024 compared with $4.6 million for the prior-year quarter. This was driven by an increase of $0.5 million due to higher COGS for lamp revenue, partially offset by a decrease of $0.2 million due to the decrease in sales of Ameluz^®.

Selling, general and administrative expenses were $8.4 million for the third quarter of 2024 compared with $8.6 million for the third quarter of 2023. The decrease was primarily driven by a $0.5 million reduction in general business administration expenses, as well as a decrease of non-personnel sales and marketing expenses of $0.2 million, and a $0.3 million decrease in personnel costs due to change in headcount and reduced severance. This was offset by a $0.8 million increase in legal expenses related to the competitor complaints at the International Trade Commission (ITC) and the US District Court for the District of Massachusetts.

The net loss for the third quarter of 2024 was $5.7 million, compared with a net loss of $6.3 million for the prior-year quarter. Adjusted EBITDA for the third quarter of 2024 was negative $4.6 million compared with negative $3.9 million for the third quarter of 2023, reflecting our 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. The primary driver of the lower Adjusted EBITDA was increased R&D spend since we took over clinical operations for Ameluz as of June 2024.

Please refer to the table below which presents a GAAP to non-GAAP reconciliation of Adjusted EBITDA for the third quarters of 2024 and 2023.

Nine Month Financial Results

Total YTD revenues were $24.7, an increase of $1.3 million, or 5.6% as compared to the same period last year. This increase was driven by a higher unit sales price for Ameluz^® and a revenue increase in device sales due to the commercial launch of the RhodoLED XL. After a revenue decline of 9% in Q1 followed by 8% growth for the first half of the year, we would now have seen year-over-year growth of approximately 12% without the impact of the shipping delays caused by Hurricane Milton.

Total operating expenses were $40.2 million for the nine months ended September 30, 2024 compared with $42.3 million to the same period last year. Cost of revenues increased from the prior year to $13.3 million for the nine months ended September 30, 2024, compared to $12.1 million for the same period last year. Selling, general and administrative expenses decreased to $25.6 million compared to $29.9 million in the prior year. Specifically, this decrease entails $1.7 million in legal costs for the settlement with Biofrontera AG in April 2023, $1.3 million of non-personnel sales and marketing expenses due to a lower level of marketing activities in general, $0.6 million in general business administration, and $0.6 million in personnel expenses, partially offset by legal costs relating to the complaints filed by our competitor.

Adjusted EBITDA was negative $13.9 million for the nine months ended September 30, 2024 compared with negative $15.8 million for the same period last year, primarily driven by the lower SG&A costs mentioned above.

Conference Call Details

Conference call: Thursday, November 14, 2024 at 10:00 AM Eastern Time
Toll Free: 1-877-877-1275 (U.S. toll-free)
International: 1-412-858-5202
Webcast: https://event.choruscall.com/mediaframe/webcast.html?webcastid=OvxLI2Kz

About Biofrontera Inc.

Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz^® with the RhodoLED^® lamp series for PDT of Actinic Keratosis (AK), pre-cancerous skin lesions which may progress to invasive skin cancers². The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate to severe acne. For more information, visit www.biofrontera-us.com and follow Biofrontera on LinkedIn and Twitter.

1 - https://www.skincancer.org/skin-cancer-information/actinic-keratosis/

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. 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.

BIOFRONTERA INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except par value and share amounts)

BIOFRONTERA INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts and number of shares)
(Unaudited)

BIOFRONTERA INC.
GAAP TO NON-GAAP ADJUSTED EBITDA RECONCILIAITION
(In thousands, except per share amounts and number of shares)
(Unaudited)