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Biofrontera (BFRI)
NASDAQ:BFRI
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Biofrontera (BFRI) AI Stock Analysis

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BFRI

Biofrontera

(NASDAQ:BFRI)

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Neutral 48 (OpenAI - Gpt-5.6Sol)
Rating:48Neutral
Price Target:
$0.82
▼(-44.83% Downside)
Action:Reiterated
Date:10/15/26
The score is held down primarily by weak financial quality—ongoing losses, persistent cash burn, and a thinner equity cushion with rising leverage—along with bearish technicals. Offsetting factors include improving operating trends and guidance toward cash-flow breakeven, plus a major FDA approval expanding Ameluz’s indication, but liquidity and ITC-related execution risk remain meaningful.
Positive Factors
Revenue and Unit Growth
Strong revenue growth is supported by increased product demand rather than only reported sales expansion. Higher Ameluz volumes and customer ordering activity indicate improving commercial adoption, which can strengthen the recurring consumable-sales base over the next several quarters.
Negative Factors
Liquidity and Financing Risk
Declining cash, continued funding needs, and a going concern qualification indicate limited financial flexibility. If operating improvements or expected milestones are delayed, Biofrontera may need external financing or a working-capital facility, potentially constraining investment in commercialization and clinical programs.
Read all positive and negative factors
Positive Factors
Negative Factors
Revenue and Unit Growth
Strong revenue growth is supported by increased product demand rather than only reported sales expansion. Higher Ameluz volumes and customer ordering activity indicate improving commercial adoption, which can strengthen the recurring consumable-sales base over the next several quarters.
Read all positive factors

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

Biofrontera Business Overview & Revenue Model

Company Description
Biofrontera Inc., a biopharmaceutical company, engages in the commercialization of pharmaceutical products for the treatment of dermatological conditions in the United States. It offers Ameluz, BF-RhodoLED, RhodoLED XL lamp series, and RhodoLED La...
How the Company Makes Money
Biofrontera generates revenue primarily from commercial sales of its dermatology products in the U.S., led by sales of Ameluz topical gel (a prescription topical photosensitizing agent) and the associated BF-RhodoLED lamp system used to activate p...

Biofrontera Earnings Call Summary

Earnings Call Date:Aug 13, 2026
(Q2-2026)
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% Change Since: |
Next Earnings Date:Nov 18, 2026
Earnings Call Sentiment Positive
The call conveyed strong operational and commercial momentum: double-digit revenue growth, substantial gross margin expansion, marked improvement in adjusted EBITDA, and clear near-term clinical catalysts (sBCC PDUFA and AK label expansion) that leverage the existing installed base. Key risks include an adverse ITC ruling temporarily restricting sales to accounts with the RhodoLED XL (affecting a meaningful minority of lamps), the need for border approval of a remedial lamp design, and a modest cash position with a going concern disclosure that may require additional financing. On balance, the positive operational trends and pipeline catalysts outweigh the near-term legal and liquidity headwinds, but successful remediation, timely approvals, and working capital execution remain critical.
Positive Updates
Strong Quarterly and H1 Revenue Growth
Net product revenue grew ~32.9% year-over-year to $12.0M in Q2 2026 and revenue for the first half was $22.1M, up 25.4% versus H1 2025.
Negative Updates
ITC Ruling Impacting RhodoLED XL
On May 6 the ITC found a Section 337 violation for two Sun Pharmaceutical patents, issuing a limited exclusion order and cease-and-desist orders effective July 7 that prohibit importing or selling the current RhodoLED XL lamp in the U.S. and restrict selling Ameluz for use with the XL device; estimated remediation cost recorded of approximately $500K.
Read all updates
Q2-2026 Updates
Negative
Strong Quarterly and H1 Revenue Growth
Net product revenue grew ~32.9% year-over-year to $12.0M in Q2 2026 and revenue for the first half was $22.1M, up 25.4% versus H1 2025.
Read all positive updates
Company Guidance
Management guided that Biofrontera expects to achieve cash‑flow breakeven in 2026 while maintaining its full‑year revenue objectives (not quantified on the call), and highlighted near‑term regulatory and commercial milestones: a PDUFA target date of September 28, 2026 for superficial BCC with a planned full launch in Q1 2027, a supplemental NDA filing for AK on extremities/neck/trunk around end‑Q3 2026 with anticipated approval in Q3 2027, and progression of an acne program toward later‑stage trials; they noted the ITC exclusion order on the RhodoLED XL should affect timing more than total demand, remediation costs are estimated at roughly $0.5M (recorded in Q1), the non‑infringing XL will be submitted via a CBE‑30, and the company may tap a $1M XEPI milestone and/or a working‑capital facility if needed. Key operating and financial metrics cited to support guidance included Q2 product revenue of $12.0M (+32.9% YoY) and H1 revenue of $22.1M (+25.4%), Q2 Ameluz unit sales of 33,300 tubes (vs ~25,300 a year ago, ~30% unit growth), an installed base of ~801 lamps across ~740 offices (≈243 XLs), Q2 gross margin ~80% (vs ~71% prior year), Q2 adjusted EBITDA essentially breakeven (~‑$0.2M vs ‑$5.1M prior) and H1 adjusted EBITDA ‑$3.7M (vs ‑$9.5M), Q2 net loss $0.6M ($0.05/sh) vs $5.3M ($0.57/sh) prior, cash of $4.7M at 6/30/26 (vs $6.4M at 12/31/25), H1 operating cash used $1.7M (down from $7.2M), H1 order count +18.6%, average tubes per order +10%, 81% of large pre‑price‑increase customers reordered with their volume +41%, 66 net new accounts in H1 (vs 69), and inside sales contribution of ~1,070 tubes (whitespace) +920 tubes (vacant territories) in H1.

Biofrontera Financial Statement Overview

Summary
Revenue is growing and margins improved sharply (TTM gross margin ~84.5%) with narrowing losses, but the company remains unprofitable at the operating line and cash generation is a key weakness (negative operating cash flow and free cash flow, including -$7.9M FCF in TTM). Balance-sheet risk has increased as equity declined and leverage rose (debt-to-equity 1.26 in TTM), limiting flexibility if losses persist.
Income Statement
34
Negative
Balance Sheet
41
Neutral
Cash Flow
24
Negative
BreakdownTTMDec 2025Dec 2024Dec 2023Dec 2022Mar 2022
Income Statement
Total Revenue46.17M41.70M37.30M34.07M28.67M24.10M
Gross Profit39.00M32.80M18.70M16.63M13.49M11.36M
EBITDA-5.43M-9.19M-14.44M-18.45M934.00K-36.76M
Net Income-6.37M-10.54M-17.76M-20.13M-640.00K-37.71M
Balance Sheet
Total Assets24.06M28.56M22.10M27.93M50.88M53.22M
Cash, Cash Equivalents and Short-Term Investments4.67M6.39M5.91M1.42M27.76M24.55M
Total Debt7.50M6.16M4.92M5.40M1.35M0.00
Total Liabilities18.11M18.08M17.67M23.14M27.01M41.88M
Stockholders Equity5.96M10.48M4.43M4.79M23.88M11.34M
Cash Flow
Free Cash Flow-7.93M-13.36M-10.33M-24.90M-16.24M-26.73M
Operating Cash Flow-7.93M-13.36M-10.27M-24.89M-16.20M-26.71M
Investing Cash Flow3.00M3.00M-3.00K619.00K-5.16M-11.00K
Financing Cash Flow2.35M10.85M14.84M8.41M14.02M43.19M

Biofrontera Technical Analysis

Technical Analysis Sentiment
Negative
Last Price1.49
Price Trends
50DMA
1.21
Negative
100DMA
1.14
Negative
200DMA
1.03
Negative
Market Momentum
MACD
-0.12
Positive
RSI
29.18
Positive
STOCH
3.46
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For BFRI, the sentiment is Negative. The current price of 1.49 is above the 20-day moving average (MA) of 0.91, above the 50-day MA of 1.21, and above the 200-day MA of 1.03, indicating a bearish trend. The MACD of -0.12 indicates Positive momentum. The RSI at 29.18 is Positive, neither overbought nor oversold. The STOCH value of 3.46 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative 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
55
Neutral
$20.83M-95.74-0.80%―27.78%52.88%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
48
Neutral
$11.72M-1.32-127.78%―17.83%73.13%
41
Neutral
$166.70K>-0.01-1358.66%1.44%――
41
Neutral
$3.76M-3.12206.75%―――
41
Neutral
$26.27M-0.40-118.89%―33.82%34.05%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
BFRI
Biofrontera
0.79
-0.24
-23.02%
PRPH
Prophase Labs
0.01
-3.75
-99.73%
TXMD
TherapeuticsMD
1.80
0.49
37.40%
RDHL
RedHill Biopharma
0.42
-1.15
-73.06%
COSM
Cosmos Holdings
0.26
-0.65
-71.48%
GELS
Gelteq Limited
0.43
-0.78
-64.46%

Biofrontera Corporate Events

Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
Biofrontera Gains FDA Approval for Ameluz Skin Cancer Use
Positive
Sep 14, 2026
On September 14, 2026, Biofrontera announced that the U.S. Food and Drug Administration approved a supplemental New Drug Application for Ameluz 10% topical gel used with the BF-RhodoLED lamp series to treat superficial basal cell carcinoma in adul...
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: Oct 15, 2026