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Biofrontera (BFRI)
NASDAQ:BFRI

Biofrontera (BFRI) AI Stock Analysis

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BFRI

Biofrontera

(NASDAQ:BFRI)

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Neutral 45 (OpenAI - 5.2)
Rating:45Neutral
Price Target:
$0.91
▲(22.57% Upside)
The score is held down primarily by weak financial performance—persistent operating losses, continued cash burn, and negative equity. Technicals are mixed and do not provide strong confirmation of a durable uptrend, while valuation is difficult to support given negative earnings and no dividend. Offsetting factors include earnings-call guidance targeting FY2026 cash-flow breakeven and margin improvement from acquiring U.S. rights, but near-term listing/compliance risk remains a notable headwind.
Positive Factors
Strong product-level margins
A ~66% gross margin indicates robust unit economics for Ameluz and related devices, providing a durable cushion to absorb SG&A and R&D. If revenue scales, these margins can drive sustainable operating leverage and faster path to profitability once fixed costs are aligned.
Control of U.S. commercialization
Owning U.S. rights centralizes commercialization, enabling higher realized margins, streamlined pricing and channel decisions, and better capture of downstream device and consumable revenue. This structural change can materially improve long-term cash conversion and margin sustainability.
Extended patent protection
A new formulation patent stretching protection to 2043 strengthens the IP moat around Ameluz, supporting pricing power and deterring generic entrants. It underpins longer-term return on R&D and makes investment in new indications more strategically attractive.
Negative Factors
Ongoing cash burn and weak equity
Sustained negative operating and free cash flow with negative equity constrains liquidity and financing flexibility. Absent sustained EBITDA improvement or new capital, the balance sheet limits strategic optionality and raises dilution or covenant risk over the medium term.
Recent revenue softness
A weakened recent revenue trajectory reduces operating leverage and makes high fixed SG&A and legal costs more acute. Slower top-line growth increases dependence on non-core asset sales or financing to reach cash-flow breakeven and delays durable margin recovery.
Nasdaq listing compliance risk
A formal Nasdaq noncompliance notice introduces structural listing and governance risk that can hinder capital raises, attract remediation actions (reverse split) and distract management. Listing uncertainty materially affects long-term access to public capital and strategic flexibility.

Biofrontera (BFRI) vs. SPDR S&P 500 ETF (SPY)

Biofrontera Business Overview & Revenue Model

Company DescriptionBiofrontera Inc., a biopharmaceutical company, engages in the commercialization of pharmaceutical products for the treatment of dermatological conditions in the United States. The company offers Ameluz, which is a prescription drug approved for use in combination with the company's licensor's medical device; and the RhodoLED lamp series for photodynamic therapy for the lesion-directed and field-directed treatment of actinic keratosis of mild-to-moderate severity on the face and scalp. It also Xepi, a prescription cream for the treatment of impetigo. The company was incorporated in 2015 and is headquartered in Woburn, Massachusetts.
How the Company Makes MoneyBiofrontera generates revenue primarily through the sale of its pharmaceutical products, particularly Ameluz, which is marketed in various regions including Europe and the United States. The company operates a direct sales model in certain markets while also leveraging partnerships with distributors to reach a broader audience. Key revenue streams include product sales, royalties from licensing agreements, and potential milestone payments from collaborations with other pharmaceutical companies. The company may also benefit from strategic partnerships that enhance its market presence and expand its product offerings, thus contributing to its overall earnings.

Biofrontera Earnings Call Summary

Earnings Call Date:Nov 13, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Apr 03, 2026
Earnings Call Sentiment Neutral
The earnings call presented a mixed picture, with stable year-to-date revenues, strategic expansions, successful patent approval, and financial agreements being positive aspects. However, these were countered by a decline in third-quarter revenues, increased legal costs, and a higher net loss.
Q3-2025 Updates
Positive Updates
Stable Year-to-Date Revenues
Biofrontera's year-to-date revenues until September 30, 2025, remained approximately flat compared to the same period in 2024, despite fewer buying opportunities and no price increase.
Strategic Expansion and Patent Approval
Biofrontera plans to submit a new FDA application for Ameluz to treat superficial basal cell carcinoma, and they received patent approval for a new formulation of Ameluz, extending protection through December 2043.
Transformational Agreement and Investment
Biofrontera completed a significant agreement with Biofrontera AG, acquiring all U.S. rights for Ameluz and RhodoLED, expected to enhance gross margins. They also secured an $11 million investment from institutional investors.
Xepi Divestment and Financial Position
Completed the sale of Xepi license, receiving $3 million at closing, with potential for an additional $7 million. This, along with other financing, is expected to support cash flow breakeven by fiscal year 2026.
Negative Updates
Decline in Q3 Revenues
Total revenues for the third quarter of 2025 were $7.0 million, a 22% decrease from $9.0 million in the third quarter of 2024, attributed to a lack of buying opportunities following a past price increase.
Increased Legal Costs
Selling, general, and administrative expenses increased due to higher legal costs related to patent claims, impacting the financial results of the quarter.
Increased Net Loss and Adjusted EBITDA
Net loss for Q3 2025 was $6.6 million, compared to $5.7 million in the prior year quarter. Adjusted EBITDA was negative $6.0 million, compared to negative $4.6 million in Q3 2024.
Company Guidance
During Biofrontera Inc.'s third-quarter 2025 financial results and business update conference call, CEO Hermann Luebbert provided guidance indicating a transient revenue dip due to a lack of buy-in opportunities following the previous year's price increase. The company anticipates strong revenue growth in the fourth quarter of 2025, driven by an expanded installed base of approximately 750 RhodoLED lamps and potential new indications for Ameluz. Financially, Biofrontera reported a 22% year-over-year decline in third-quarter revenues to $7.0 million, attributed to the 2024 price increase effect, while operating expenses decreased to $13.3 million. The net loss for the quarter was $6.6 million, with an adjusted EBITDA of negative $6.0 million. For the first nine months of 2025, total revenues were relatively flat at $24.6 million, with operating expenses at $40.5 million. The company recently completed a strategic agreement with Biofrontera AG, acquiring all U.S. rights for Ameluz and RhodoLED, expected to enhance gross margins and profitability. Additionally, the company has secured an $11 million investment and completed the Xepi license divestiture, positioning for cash flow breakeven in fiscal year 2026.

Biofrontera Financial Statement Overview

Summary
Financial profile is weak: despite strong gross margin (~66%) and longer-term revenue scaling, the company remains deeply unprofitable (TTM operating margin ~-46%, net margin ~-47%) with ongoing cash burn (TTM operating and free cash flow about -$12M). Balance sheet risk is elevated with negative stockholders’ equity (about -$2.6M) and a shrinking asset base, limiting financial flexibility.
Income Statement
22
Negative
Revenue scale improved materially versus 2020 (about $18.8M to $37.2M in TTM (Trailing-Twelve-Months)), but the growth trajectory has weakened recently (TTM revenue down ~5% vs. the prior annual period). Profitability remains the key issue: TTM gross margin is strong (~66%), yet operating losses are substantial (TTM operating margin around -46%) and net margin is deeply negative (~-47%), indicating costs are not aligned with the current revenue base. Overall, the business shows decent product-level economics but has not translated that into sustainable operating profitability.
Balance Sheet
18
Very Negative
Balance sheet pressure is elevated: stockholders’ equity is negative in TTM (about -$2.6M), which is a major financial flexibility red flag and can constrain access to capital. Total debt is modest in absolute terms (~$4.9M), but leverage metrics become distorted with negative equity and suggest heightened balance sheet risk. Total assets have also declined meaningfully versus earlier years (about $50.9M in 2022 to $15.4M in TTM), reinforcing a weakening capital base despite relatively limited debt.
Cash Flow
20
Very Negative
Cash generation remains weak: TTM operating cash flow is negative (about -$12.0M) and free cash flow is also negative (about -$12.0M), implying ongoing cash burn to fund operations. There is improvement versus 2023 (when operating cash flow was roughly -$24.9M), but the company still is not self-funding and will likely require continued financing support if losses persist. Overall cash flow trends are moving in the right direction, but not yet to a sustainable level.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue37.16M37.30M34.07M28.67M24.10M18.85M
Gross Profit24.52M18.70M16.63M13.49M11.36M9.78M
EBITDA-16.29M-14.44M-18.45M934.00K-36.76M-7.46M
Net Income-17.57M-17.76M-20.13M-640.00K-37.71M-10.99M
Balance Sheet
Total Assets15.41M22.10M27.93M50.88M53.22M24.14M
Cash, Cash Equivalents and Short-Term Investments3.42M5.91M1.42M27.76M24.55M8.08M
Total Debt4.91M4.92M5.40M1.35M0.000.00
Total Liabilities18.00M17.67M23.14M27.01M41.88M18.31M
Stockholders Equity-2.58M4.43M4.79M23.88M11.34M5.83M
Cash Flow
Free Cash Flow-12.01M-10.33M-24.90M-16.24M-26.73M-12.37M
Operating Cash Flow-12.00M-10.27M-24.89M-16.20M-26.71M-12.37M
Investing Cash Flow-4.00K-3.00K619.00K-5.16M-11.00K0.00
Financing Cash Flow12.55M14.84M8.41M14.02M43.19M13.19M

Biofrontera Technical Analysis

Technical Analysis Sentiment
Positive
Last Price0.74
Price Trends
50DMA
0.81
Positive
100DMA
0.90
Positive
200DMA
0.84
Positive
Market Momentum
MACD
0.05
Negative
RSI
57.33
Neutral
STOCH
79.56
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For BFRI, the sentiment is Positive. The current price of 0.74 is below the 20-day moving average (MA) of 0.88, below the 50-day MA of 0.81, and below the 200-day MA of 0.84, indicating a bullish trend. The MACD of 0.05 indicates Negative momentum. The RSI at 57.33 is Neutral, neither overbought nor oversold. The STOCH value of 79.56 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for BFRI.

Biofrontera Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
52
Neutral
$25.00M82.760.27%75.19%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
47
Neutral
$6.21M
45
Neutral
$10.84M-0.51-1191.73%5.11%19.78%
42
Neutral
$1.47M-0.01
40
Underperform
$17.98M-0.68-63.82%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
BFRI
Biofrontera
0.93
-0.19
-16.96%
PRPH
Prophase Labs
0.16
-2.51
-94.19%
TXMD
TherapeuticsMD
2.16
1.13
109.71%
RDHL
RedHill Biopharma
1.22
-4.66
-79.25%
COSM
Cosmos Holdings
0.48
-0.24
-33.61%
GELS
Gelteq Limited
0.97
-1.23
-55.91%

Biofrontera Corporate Events

Delistings and Listing ChangesRegulatory Filings and ComplianceStock Split
Biofrontera Receives Nasdaq Notice on Bid Price Noncompliance
Negative
Jan 7, 2026

On December 31, 2025, Biofrontera Inc., a Delaware corporation listed on the Nasdaq Capital Market, was notified by Nasdaq that its common stock had fallen out of compliance with the exchange’s minimum bid price requirement after trading below $1.00 for 34 consecutive business days. While the notice does not immediately affect the trading or listing of the shares, the company has until June 30, 2026, to lift its closing bid price to at least $1.00 for 10 consecutive business days or potentially secure an additional compliance period, failing which it could face delisting, appeal processes, or the need for measures such as a reverse stock split as it seeks to preserve its Nasdaq listing and reassure stakeholders about ongoing compliance risks.

The most recent analyst rating on (BFRI) stock is a Hold with a $0.79 price target. To see the full list of analyst forecasts on Biofrontera stock, see the BFRI Stock Forecast page.

Delistings and Listing ChangesRegulatory Filings and Compliance
Biofrontera Regains Nasdaq Compliance in November 2025
Positive
Nov 10, 2025

Biofrontera Inc. has announced that it has regained compliance with Nasdaq’s continued listing requirements under Listing Rules 5550(b)(1) and 5550(a)(2) as of November 4 and November 6, 2025, respectively. This compliance follows previous notifications of non-compliance due to the company’s stockholders’ equity and stock price falling below required thresholds earlier in 2025, impacting its market positioning and potentially averting delisting threats.

The most recent analyst rating on (BFRI) stock is a Buy with a $3.00 price target. To see the full list of analyst forecasts on Biofrontera stock, see the BFRI Stock Forecast page.

Business Operations and StrategyM&A TransactionsProduct-Related Announcements
Biofrontera Completes Sale of Xepi US License
Positive
Nov 7, 2025

On November 6, 2025, Biofrontera Inc. completed the sale of its US license for Xepi® (ozenoxacin) Cream to Pelthos Therapeutics Inc. for up to $10 million. The transaction, which includes an initial $3 million payment and potential milestone payments, aims to strengthen Biofrontera’s cash position and support the growth of its photodynamic therapy platform, particularly the expansion of Ameluz® into additional indications. This strategic move is expected to fund the company to profitability and allows Biofrontera to focus on its core PDT franchise.

The most recent analyst rating on (BFRI) stock is a Hold with a $1.00 price target. To see the full list of analyst forecasts on Biofrontera stock, see the BFRI Stock Forecast page.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Jan 08, 2026