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Biofrontera Inc. Reports Second Quarter 2024 Financial Results and Provides a Business Update

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Biofrontera Inc. (NASDAQ:BFRI) reported financial results for Q2 2024, showing significant growth. Total revenues increased 34% to $7.8 million compared to Q2 2023. The company's cash position improved to $4.4 million as of June 30, 2024. Biofrontera launched the FDA-approved RhodoLED® XL lamp in June and took control of all U.S. clinical trials for Ameluz®.

Despite revenue growth, the company reported a net loss of $257,000 for Q2 2024, a substantial improvement from the $9.8 million loss in Q2 2023. Adjusted EBITDA was negative $4.7 million, compared to negative $7.9 million in the prior-year quarter. The company raised an additional $8.0 million in May 2024 from warrant exercises and has paid down all outstanding debt.

Biofrontera Inc. (NASDAQ:BFRI) ha riportato i risultati finanziari per il secondo trimestre del 2024, mostrando una crescita significativa. Le entrate totali sono aumentate del 34%, raggiungendo 7,8 milioni di dollari rispetto al secondo trimestre del 2023. La posizione di cassa dell'azienda è migliorata a 4,4 milioni di dollari al 30 giugno 2024. Biofrontera ha lanciato la lampada RhodoLED® XL, approvata dalla FDA, a giugno ed ha assunto il controllo di tutti gli studi clinici negli Stati Uniti per Ameluz®.

Nonostante la crescita delle entrate, l'azienda ha riportato una perdita netta di 257.000 dollari per il secondo trimestre del 2024, un miglioramento sostanziale rispetto alla perdita di 9,8 milioni di dollari nel secondo trimestre del 2023. L'EBITDA rettificato è stato negativo per 4,7 milioni di dollari, rispetto a un negativo di 7,9 milioni di dollari nello stesso trimestre dell'anno precedente. L'azienda ha raccolto ulteriori 8,0 milioni di dollari a maggio 2024 tramite esercizi di warrant e ha estinto tutto il debito in sospeso.

Biofrontera Inc. (NASDAQ:BFRI) informó resultados financieros para el segundo trimestre de 2024, mostrando un crecimiento significativo. Los ingresos totales aumentaron un 34%, alcanzando 7.8 millones de dólares en comparación con el segundo trimestre de 2023. La posición de efectivo de la empresa mejoró a 4.4 millones de dólares a partir del 30 de junio de 2024. Biofrontera lanzó la lámpara RhodoLED® XL, aprobada por la FDA, en junio y tomó el control de todos los ensayos clínicos en EE.UU. para Ameluz®.

A pesar del crecimiento de los ingresos, la compañía reportó una pérdida neta de 257,000 dólares para el segundo trimestre de 2024, una mejora sustancial respecto a la pérdida de 9.8 millones de dólares en el segundo trimestre de 2023. El EBITDA ajustado fue negativo de 4.7 millones de dólares, en comparación con un negativo de 7.9 millones de dólares en el mismo trimestre del año anterior. La compañía recaudó 8.0 millones de dólares adicionales en mayo de 2024 a través de ejercicios de opciones y ha pagado toda la deuda pendiente.

Biofrontera Inc. (NASDAQ:BFRI)는 2024년 2분기 재무 결과를 발표하며 상당한 성장을 보여주었습니다. 총 수익은 2023년 2분기 대비 34% 증가하여 780만 달러에 달했습니다. 회사의 현금 보유량은 2024년 6월 30일 기준으로 440만 달러로 개선되었습니다. Biofrontera는 6월에 FDA 승인을 받은 RhodoLED® XL 램프를 출시하고 Ameluz®의 미국 내 모든 임상 시험을 관리하게 되었습니다.

수익 성장이 있었음에도 불구하고, 회사는 2024년 2분기에 257,000달러의 순손실을 보고했으며, 이는 2023년 2분기의 980만 달러 손실에서 상당한 개선을 이루었습니다. 조정된 EBITDA는 470만 달러의 적자를 기록했으며, 이는 전년 동기 대비 790만 달러의 적자와 비교됩니다. 회사는 2024년 5월에 워런트 발행을 통해 추가로 800만 달러를 모금했으며, 모든 미지급 부채를 상환했습니다.

Biofrontera Inc. (NASDAQ:BFRI) a annoncé ses résultats financiers pour le deuxième trimestre 2024, affichant une croissance significative. Les revenus totaux ont augmenté de 34 % pour atteindre 7,8 millions de dollars par rapport au deuxième trimestre 2023. La position de trésorerie de l'entreprise s'est améliorée à 4,4 millions de dollars au 30 juin 2024. Biofrontera a lancé la lampe RhodoLED® XL, approuvée par la FDA, en juin et a pris le contrôle de tous les essais cliniques aux États-Unis pour Ameluz®.

Malgré la croissance des revenus, l'entreprise a enregistré une perte nette de 257 000 dollars pour le deuxième trimestre 2024, marquant une amélioration substantielle par rapport à la perte de 9,8 millions de dollars au deuxième trimestre 2023. L'EBITDA ajusté était négatif de 4,7 millions de dollars, contre un négatif de 7,9 millions de dollars au cours du trimestre de l'année précédente. L'entreprise a levé 8,0 millions de dollars supplémentaires en mai 2024 grâce à des exercices de bons et a remboursé l'intégralité de sa dette en cours.

Biofrontera Inc. (NASDAQ:BFRI) berichtete über die finanziellen Ergebnisse für das zweite Quartal 2024 und zeigte ein signifikantes Wachstum. Die Gesamterlöse stiegen um 34 % auf 7,8 Millionen US-Dollar im Vergleich zum zweiten Quartal 2023. Die Liquiditätsposition des Unternehmens verbesserte sich zum 30. Juni 2024 auf 4,4 Millionen US-Dollar. Biofrontera brachte im Juni die von der FDA genehmigte RhodoLED® XL-Lampe auf den Markt und übernahm die Kontrolle über alle klinischen Studien in den USA für Ameluz®.

Trotz des Umsatzwachstums verzeichnete das Unternehmen einen Nettoverlust von 257.000 US-Dollar für das zweite Quartal 2024, was eine erhebliche Verbesserung gegenüber dem Verlust von 9,8 Millionen US-Dollar im zweiten Quartal 2023 darstellt. Das bereinigte EBITDA lag bei minus 4,7 Millionen US-Dollar, verglichen mit minus 7,9 Millionen US-Dollar im Vorjahresquartal. Das Unternehmen hat im Mai 2024 zusätzliche 8,0 Millionen US-Dollar durch die Ausübung von Warrants aufgenommen und alle ausstehenden Schulden beglichen.

Positive
  • Total revenues increased 34% year-over-year to $7.8 million in Q2 2024
  • Cash and cash equivalents improved to $4.4 million as of June 30, 2024
  • Successfully launched FDA-approved RhodoLED® XL lamp in June 2024
  • Net loss decreased significantly from $9.8 million in Q2 2023 to $257,000 in Q2 2024
  • Raised $8.0 million from warrant exercises in May 2024
  • Paid down all outstanding debt
Negative
  • Reported net loss of $257,000 in Q2 2024
  • Negative Adjusted EBITDA of $4.7 million in Q2 2024
  • Total operating expenses of $12.9 million in Q2 2024
  • Cost of revenues increased to $4.3 million in Q2 2024 from $2.9 million in Q2 2023

Insights

Biofrontera's Q2 2024 results show mixed signals. The 34% year-over-year revenue increase to $7.8 million is impressive, indicating strong market traction. However, the company still reports a net loss, albeit significantly reduced from $9.8 million to $257,000. The improved cash position ($4.4 million vs $1.3 million) and $8 million raised from warrant exercises are positive, enhancing financial stability.

The reduction in operating expenses, particularly in SG&A, demonstrates effective cost management. The negative Adjusted EBITDA of $4.7 million, while improved, indicates the company is still not cash flow positive. The launch of RhodoLED® XL and control over Ameluz® clinical trials could drive future growth and cost efficiencies, but their financial impact remains to be seen.

The takeover of Ameluz® clinical trials in the US is a strategic move that could accelerate product development and market expansion. This direct control allows for more efficient trial management and potentially faster regulatory approvals. The launch of the FDA-approved RhodoLED® XL lamp is another positive development, expanding Biofrontera's product portfolio in photodynamic therapy.

The combination of Ameluz® with RhodoLED® XL creates a synergistic product offering, potentially enhancing treatment efficacy and market penetration in dermatology. However, the impact on patient outcomes and market adoption rates needs to be closely monitored. The company's focus on dermatologic products, particularly in actinic keratosis treatment, positions it well in a growing market segment, but competition and reimbursement challenges remain key factors to watch.

Woburn, MA, Aug. 14, 2024 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, today reported financial results for the three and six months ended June 30, 2024 and provided a business update.

Highlights from the second quarter of 2024 and subsequent weeks included the following:

  • Total revenues for the second quarter of 2024 were $7.8 million, a 34% increase from the same period of the prior year
  • Cash and cash equivalents were $4.4 million as of June 30, 2024, compared with $1.3 million on December 31, 2023
  • Biofrontera announced the launch of a new, FDA-approved red-light source, the RhodoLED® XL lamp in June and installed several lamps by June 30th, 2024
  • Took control of all clinical trials relating to Ameluz® in the US, allowing for more effective cost management and direct oversight of trial efficiency
  • Biofrontera raised an additional $8.0M in May 2024 from the exercise of warrants and has since paid down all outstanding debt

Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc., stated, "This was a very exciting period for us as we got our sales and marketing efforts in full swing during the first half of the year. Additionally, on June 10th we launched the commercial distribution of the RhodoLED XL and I am pleased to say that we shipped the first three machines within 1 week of launch. The RhodoLED XL is approved by the FDA in combination with Ameluz®.”

“On June 1st, under the amended Ameluz License and Supply Agreement, we took control of all clinical trials relating to Ameluz® in the US, allowing direct interaction with participating clinical centers. The reduced transfer price will allow us to finance R&D activities and continue our commercial growth trajectory, while reducing our overall costs,” concluded Prof. Luebbert

Second Quarter Financial Results

Total revenues for the second quarter of 2024 were $7.8 million compared with $5.8 million for the second quarter of 2023. The increase is due in part to a catch-up from lower sales in 1Q driven by reimbursement challenges stemming from the Change Healthcare cyber security event.

Total operating expenses were $12.9 million for the second quarter of 2024 compared with $14.5 million for the second quarter of 2023. Cost of revenues was $4.3 million for the second quarter of 2024 compared with $2.9 million for the prior-year quarter, with the increase driven by increased sales. Selling, general and administrative expenses were $7.9 million for the second quarter of 2024 compared with $11.5 million for the second quarter of 2023. The decrease was primarily driven by our continued effort to control cost and lower legal expenses compared to the same period in 2023.

The net loss for the second quarter of 2024 was $257 thousand, compared with a net loss of $9.8 million, for the prior-year quarter. The decrease in the net loss is attributed to lower selling, general, and administrative costs as well as changes in non-cash P&L items including the fair value of warrants and investments in related parties.

Adjusted EBITDA for the second quarter of 2024 was negative $4.7 million compared with negative $7.9 million for the second quarter of 2023, reflecting our lower 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.

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

Six Month Financial Results

Total revenues were $15.8 million for the first half of 2024 compared with $14.6 million for the first half of 2023. This 8.2% increase was primarily driven by continued penetration of the photodynamic therapy and cryotherapy AK market segments.

Total operating expenses were $26.3 million for the first half of 2024 compared with $28.8 million for the first half of 2023. Cost of revenues increased slightly from the prior year to $8.5 million for the first six months of 2024 compared to $7.5 million for the first half of 2023. Selling, general and administrative expenses decreased to $17.2 million compared to $21.4 million in the prior year. The decrease was primarily driven by our continued effort to control cost and lower legal expenses compared to the same period in 2023.The net loss for the first half of 2024 was $10.7 million, compared with a net loss of $17.3 million for the first half of 2023.

Adjusted EBITDA was negative $9.3 million for the first half of 2024 compared with negative $11.9 million for the first half of 2023.

Conference Call Details

Conference call: Thursday, August 15, 2024 at 10:00 AM ET
Toll Free: 1-877-877-1275 (U.S. toll-free)
International: 1-412-858-5202
Webcast: https://event.choruscall.com/mediaframe/webcast.html?webcastid=bU2HFqrt

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 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. 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.

(Tables follow)

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

  June 30,
2024
  December 31,
2023
 
   (Unaudited)     
ASSETS        
Current assets:        
Cash and cash equivalents $4,379  $1,343 
Investment, related party  10   78 
Accounts receivable, net  3,504   5,162 
Inventories, net  3,946   10,908 
Prepaid expenses and other current assets  473   425 
Other assets, related party  5,159   5,159 
         
Total current assets  17,471   23,075 
         
Property and equipment, net  101   134 
Operating lease right-of-use assets  1,230   1,612 
Intangible asset, net  2,448   2,629 
Other assets  324   482 
         
Total assets $21,574  $27,932 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Current liabilities:        
Accounts payable  2,413   3,308 
Accounts payable, related parties  2,265   5,698 
Operating lease liabilities  701   691 
Accrued expenses and other current liabilities  3,593   4,487 
Short term debt  296   3,904 
         
Total current liabilities  9,268   18,088 
         
Long-term liabilities:        
Warrant liabilities  921   4,210 
Operating lease liabilities, non-current  443   804 
Other liabilities  31   37 
         
Total liabilities  10,663   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, 4,806 Series B-2 and 7,998 Series B-3 shares issued and outstanding as of June 30, 2024 and no shares issued and outstanding as of December 31, 2023  -   - 
Common stock, $0.001 par value, 35,000,000 shares authorized; 5,094,184 and 1,517,628 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively  5   2 
Additional paid-in capital  121,250   104,441 
Accumulated deficit  (110,344)  (99,650)
         
Total stockholders’ equity  10,911   4,793 
         
Total liabilities and stockholders’ equity $21,574  $27,932 


BIOFRONTERA INC.

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

  Three Months Ended
June 30,
  Six Months Ended
June 30,
 
  2024  2023  2024  2023 
             
Product revenues, net $7,831  $5,830  $15,732  $14,544 
Revenues, related party  8   18   18   36 
                 
Total revenues, net  7,839   5,848   15,750   14,580 
                 
Operating expenses                
Cost of revenues, related party  4,092   2,772   8,038   7,319 
Cost of revenues, other  250   116   421   167 
                 
Selling, general and administrative  7,915   11,456   17,163   21,254 
Selling, general and administrative, related party  32   92   29   119 
Research and development  621   11   637   11 
Change in fair value of contingent consideration  -   100   -   (100)
                 
Total operating expenses  12,910   14,547   26,288   28,770 
                 
Loss from operations  (5,071)  (8,699)  (10,538)  (14,190)
                 
Other income (expense)                
Change in fair value of warrants  5,438   375   2,009   1,403 
Change in fair value of investment, related party  (14)  (1,482)  (11)  (4,424)
Loss on debt extinguishment  -   -   (316)  - 
Interest expense, net  (596)  (79)  (2,003)  (114)
Other income, net  6   62   186   30 
                 
Total other income (expense)  4,834   (1,124)  (135)  (3,105)
                 
Loss before income taxes  (237)  (9,823)  (10,673)  (17,295)
Income tax expense  20   14   21   20 
                 
Net loss $(257) $(9,837) $(10,694) $(17,315)
                 
Loss per common share:                
Basic and diluted $(0.05) $(7.23) $(2.45) $(12.73)
                 
Weighted-average common shares outstanding:                
Basic and diluted  5,091,353   1,360,739   4,357,474   1,359,894 


BIOFRONTERA INC.

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

  Three Months Ended
June 30,
  Six Months Ended
June 30,
 
  2024  2023  2024  2023 
Net loss $(257) $(9,837) $(10,694) $(17,315)
Interest expense, net  596   79   2,003   114 
Income tax expenses  20   14   21   20 
Depreciation and amortization  130   253   258   518 
EBITDA  489   (9,491)  (8,412)  (16,663)
Loss on debt extinguishment  -   -   316   - 
Change in fair value of contingent consideration  -   100   -   (100)
Change in fair value of warrant liabilities  (5,438)  (375)  (2,009)  (1,403)
Change in fair value of investment, related party  14   1,482   11   4,424 
Legal settlement expenses  -   107   -   1,225 
Stock based compensation  204   259   432   610 
Expensed issuance costs  -   -   354   - 
Adjusted EBITDA $(4,731) $(7,918) $(9,308) $(11,907)
Adjusted EBITDA margin  -60.3%  -135.4%  -59.1%  -81.7%

FAQ

What was Biofrontera's (BFRI) revenue for Q2 2024?

Biofrontera Inc. (BFRI) reported total revenues of $7.8 million for Q2 2024, representing a 34% increase from the same period in the previous year.

Did Biofrontera (BFRI) launch any new products in Q2 2024?

Yes, Biofrontera (BFRI) launched the FDA-approved RhodoLED® XL lamp on June 10, 2024, and shipped the first three machines within one week of launch.

What was Biofrontera's (BFRI) net loss for Q2 2024?

Biofrontera (BFRI) reported a net loss of $257,000 for Q2 2024, a significant improvement from the $9.8 million net loss in Q2 2023.

How much cash did Biofrontera (BFRI) have as of June 30, 2024?

Biofrontera (BFRI) reported cash and cash equivalents of $4.4 million as of June 30, 2024, compared to $1.3 million on December 31, 2023.

Did Biofrontera (BFRI) raise any additional funds in Q2 2024?

Yes, Biofrontera (BFRI) raised an additional $8.0 million in May 2024 from the exercise of warrants and subsequently paid down all outstanding debt.

Biofrontera Inc.

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