BFRIW Biofrontera Inc

 

 

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): November 13, 2024

 

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 November 13, 2024, Biofrontera Inc. (the “Company”) issued a press release announcing its financial and operational results for the three and nine months ended September 30, 2024. 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.

 

99.1		Press release dated November 13, 2024
104		Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document)

 

 

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.

 

November 13, 2024	Biofrontera Inc.
(Date)	(Registrant)
	/s/ E. Fred Leffler III
	E. Fred Leffler, III
	Chief Financial Officer

 

 

Exhibit 99.1

 

Biofrontera Inc. Reports Third Quarter and Nine-Month 2024 Financial Results and Provides Business Update

 

	●	Total revenues for the third quarter 2024 were $9.0 million, an increase of 1.5% from Q3 2023. Revenue increase would have been 19% if shipments were not delayed due to Hurricane Milton.
	●	Total revenues for the first 9 months were $24.8 million, an increase of $1.3 million, or 5.6% as compared to the same period last year. Without the impact of Hurricane Milton delaying shipments, the increase would have been 12%.
	●	Ameluz® achieved record volume in September 2024.
	●	Organization continues to prudently manage SG&A expenses in line with business needs with a reduction of 14% in the first 9 months of 2024 vs 2023.
	●	Cash and cash equivalents were $2.9 million as of September 30, 2024, compared with $1.3 million on December 31, 2023.
	●	RhodoLED XL launch continues to be successful with 39 installed since launch in late June 2024; additionally, 66 BF-RhodoLED lamps have been installed in the first three quarters of 2024.
	●	On October 4 FDA approved sNDA to increase the maximally allowed dosage of Ameluz® from one tube to three tubes per treatment.
	●	Preliminary results of Phase 3 sBCC study are highly statistically significant for all primary and secondary endpoints (p<0.0001). Ameluz-PDT achieved 75.9% histological clearance vs 19% with placebo.

 

WOBURN, Mass. (November 13, 2024) – Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), today reported financial results for the three and nine months ended September 30, 2024 and provided a business update.

 

Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc., stated, “While we are pleased with the third quarter results, we faced challenges from Hurricane Milton that impacted our business and that of our customers in the areas affected. The hurricane delayed the shipment of 4,640 tubes of Ameluz, representing approximately $1.5 million in revenue. All the tubes were shipped in October and will count towards Q4. As reported, this reduced our quarterly growth to 1.5% and year-to-date growth to 5.6%. Without this delay, quarterly growth would have been 19% and year-to-date growth 12%.”

 

“We have made some important progress across our business in 2024. We have seen very positive uptake of our products throughout the United States, illustrated by the number of lamps sold to dermatology offices. The transfer of clinical trial activities from Biofrontera AG to Biofrontera Inc. was seamless, with all trials progressing as planned. We continue to prepare our FDA filing for the approval of Ameluz for the treatment of sBCC, which we expect to submit in the 1^st half of 2025. If that is the case, we anticipate approval in early 2026. Furthermore, on October 4^th the FDA approved an increase in the maximally approved dosage from one to three tubes of Ameluz^® per treatment. This approval allows for larger field treatment of mild to moderate actinic keratosis on the face and scalp with Ameluz®-PDT using the BF-RhodoLED^® or the RhodoLED^® XL lamp. Based on the extended approval   we are rapidly implementing a comprehensive update to our commercial strategy that we believe will drive significant sales growth in the coming years,” concluded Prof. Luebbert.

 

 

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)

 

		September 30, 2024				December 31, 2023
		(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents		$	2,873			$	1,343
Investment, related party			8				78
Accounts receivable, net			4,874				5,162
Inventories, net			6,526				10,908
Prepaid expenses and other current assets			350				425
Assets held for sale			2,300				-
Other assets, related party			-				5,159
Total current assets			16,931				23,075
Property and equipment, net			82				134
Operating lease right-of-use assets			1,081				1,612
Intangible asset, net			39				2,629
Other assets			383				482
Total assets		$	18,516			$	27,932
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable			2,027				3,308
Accounts payable, related parties			3,680				5,698
Operating lease liabilities			670				691
Accrued expenses and other current liabilities			4,655				4,487
Short term debt			-				3,904
Total current liabilities			11,032				18,088
Long-term liabilities:
Warrant liabilities			1,601				4,210
Operating lease liabilities, non-current			324				804
Other liabilities			29				37
Total liabilities			12,986				23,139
Commitments and contingencies
Stockholders’ equity:
Series B Convertible Preferred stock, $0.001 par value, 20,000,000 shares authorized, no Series B-1, 4,695 Series B-2 and 7,093 Series B-3 shares issued and outstanding as of September 30, 2024 and no shares issued and outstanding as of December 31, 2023			-				-
Common stock, $0.001 par value, 35,000,000 shares authorized; 6,529,792 and 1,517,628 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively			7				2
Additional paid-in capital			121,536				104,441
Accumulated deficit			(116,013	)			(99,650	)
Total stockholders’ equity			5,530				4,793
Total liabilities and stockholders’ equity		$	18,516			$	27,932

 

 

BIOFRONTERA INC.

CONDENSED 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,
		2024				2023				2024				2023
Product revenues, net		$	9,012			$	8,879			$	24,744			$	23,423
Revenues, related party			-				17				18				52
Total revenues, net			9,012				8,896				24,762				23,475
Operating expenses
Cost of revenues, related party			4,801				4,495				12,839				11,814
Cost of revenues, other			76				95				496				262
Selling, general and administrative			8,425				8,619				25,589				29,874
Selling, general and administrative, related party			1				74				30				193
Research and development			669				33				1,306				44
Change in fair value of contingent consideration			-				200				-				100
Total operating expenses			13,972				13,516				40,260				42,287
Loss from operations			(4,960	)			(4,620	)			(15,498	)			(18,812	)
Other income (expense)
Change in fair value of warrants			(680	)			598				1,329				2,001
Change in fair value of investment, related party			(2	)			(2,212	)			(12	)			(6,635	)
Loss on debt extinguishment			-				-				(316	)			-
Interest income (expense), net			8				(142	)			(1,995	)			(256	)
Other income (expense), net			(32	)			35				154				65
Total other expense			(706	)			(1,721	)			(840	)			(4,825	)
Loss before income taxes			(5,666	)			(6,341	)			(16,338	)			(23,637	)
Income tax expense			3				1				25				20
Net loss		$	(5,669	)		$	(6,342	)		$	(16,363	)		$	(23,657	)
Loss per common share:
Basic and diluted		$	(0.98	)		$	(4.64	)		$	(3.39	)		$	(17.57	)
Weighted-average common shares outstanding:
Basic and diluted			5,773,993				1,366,842				4,833,091				1,346,264

 

 

BIOFRONTERA INC.

GAAP TO NON-GAAP ADJUSTED EBITDA RECONCILIAITION

(In thousands, except per share amounts and number of shares)

(Unaudited)

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2024				2023				2024				2023
Net loss		$	(5,669	)		$	(6,342	)		$	(16,363	)		$	(23,657	)
Interest expense, net			(8	)			142				1,995				256
Income tax expenses			3				1				25				20
Depreciation and amortization			129				251				387				769
EBITDA			(5,545	)			(5,948	)			(13,956	)			(22,612	)
Loss on debt extinguishment			-				-				316				-
Change in fair value of contingent consideration			-				200				-				100
Change in fair value of warrant liabilities			680				(598	)			(1,329	)			(2,001	)
Change in fair value of investment, related party			2				2,212				12				6,635
Legal settlement expenses			-				-				-				1,225
Stock based compensation			288				207				720				817
Expensed issuance costs			-				-				354				-
Adjusted EBITDA		$	(4,575	)		$	(3,927	)		$	(13,883	)		$	(15,836	)
Adjusted EBITDA margin			-50.8	%			-44.1	%			-56.1	%			-67.5	%

 

v3.24.3

Cover	Nov. 13, 2024
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 13, 2024
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
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

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