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Biofrontera
(NASDAQ:BFRI)
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Rating:46Neutral
Price Target:
$1.00
▼(-32.89% Downside)
Action:Reiterated
Date:09/16/26
The score is held down primarily by weak financial quality (ongoing losses, persistent cash burn, and a shrinking equity cushion with rising leverage) and bearish technical signals (trading below key moving averages with weak RSI/Stochastics). These are partially offset by improving operating trends and constructive guidance/catalysts from the earnings call (revenue growth, margin expansion, and a stated path toward cash-flow breakeven).
Positive Factors
Expanded addressable market
The sBCC approval broadens Ameluz beyond actinic keratosis into a larger medical-dermatology opportunity. Because the indication uses the existing gel and lamp platform, Biofrontera can potentially monetize current accounts while attracting new practices without requiring an entirely new commercial infrastructure.
Negative Factors
ITC restriction on RhodoLED XL
The ITC order directly affects part of Biofrontera’s drug-device commercial system, potentially delaying orders and limiting Ameluz sales for accounts using the current XL lamp. The business must complete remediation and obtain relevant approvals, creating execution risk around an important installed-base channel.
Read all positive and negative factors
Positive Factors
Negative Factors
Expanded addressable market
The sBCC approval broadens Ameluz beyond actinic keratosis into a larger medical-dermatology opportunity. Because the indication uses the existing gel and lamp platform, Biofrontera can potentially monetize current accounts while attracting new practices without requiring an entirely new commercial infrastructure.
Read all positive factors
Biofrontera (BFRI) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$17.38M
Dividend YieldN/A
Average Volume (3M)768.60K
Price to Earnings (P/E)―
Beta (1Y)0.92
Revenue Growth17.83%
EPS Growth73.13%
CountryUS
Employees89
SectorHealthcare
Sector Strength45
IndustryMedical - Pharmaceuticals
Share Statistics
EPS (TTM)-0.60
Shares Outstanding14,852,359
10 Day Avg. Volume998,994
30 Day Avg. Volume768,600
Financial Highlights & Ratios
PEG Ratio<0.01
Price to Book (P/B)0.55
Price to Sales (P/S)0.14
P/FCF Ratio-0.43
Enterprise Value/Market Cap<0.01
Enterprise Value/Revenue<0.01
Enterprise Value/Gross Profit<0.01
Enterprise Value/Ebitda>-0.01
Forecast
1Y Price TargetN/A
Price Target UpsideN/A
Rating ConsensusN/A
Number of Analyst Covering0
EPS Forecast (FY)-0.23
Revenue Forecast (FY)$45.65M
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)
| % 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
Positive
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
Income Statement
34
Negative
Balance Sheet
41
Neutral
Cash Flow
24
Negative
| Breakdown | TTM | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Mar 2022 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 46.17M | 41.70M | 37.30M | 34.07M | 28.67M | 24.10M |
| Gross Profit | 39.00M | 32.80M | 18.70M | 16.63M | 13.49M | 11.36M |
| EBITDA | -5.63M | -9.19M | -14.44M | -18.45M | 934.00K | -36.76M |
| Net Income | -6.37M | -10.54M | -17.76M | -20.13M | -640.00K | -37.71M |
Balance Sheet | ||||||
| Total Assets | 24.06M | 28.56M | 22.10M | 27.93M | 50.88M | 53.22M |
| Cash, Cash Equivalents and Short-Term Investments | 4.67M | 6.39M | 5.91M | 1.42M | 27.76M | 24.55M |
| Total Debt | 7.50M | 6.16M | 4.92M | 5.40M | 1.35M | 0.00 |
| Total Liabilities | 18.11M | 18.08M | 17.67M | 23.14M | 27.01M | 41.88M |
| Stockholders Equity | 5.96M | 10.48M | 4.43M | 4.79M | 23.88M | 11.34M |
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 Flow | 3.00M | 3.00M | -3.00K | 619.00K | -5.16M | -11.00K |
| Financing Cash Flow | 2.35M | 10.85M | 14.84M | 8.41M | 14.02M | 43.19M |
Biofrontera Technical Analysis
Neutral
1.49
Price Trends
1.31
Negative
1.14
Positive
1.01
Positive
Market Momentum
-0.05
Positive
41.80
Neutral
13.06
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For BFRI, the sentiment is Neutral. The current price of 1.49 is above the 20-day moving average (MA) of 1.39, above the 50-day MA of 1.31, and above the 200-day MA of 1.01, indicating a neutral trend. The MACD of -0.05 indicates Positive momentum. The RSI at 41.80 is Neutral, neither overbought nor oversold. The STOCH value of 13.06 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for BFRI.
Biofrontera Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
55 Neutral | $25.00M | -115.43 | -0.80% | ― | 27.78% | 52.88% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
49 Neutral | $35.64M | -0.62 | -118.89% | ― | 33.82% | 34.05% | |
46 Neutral | $17.38M | -1.92 | -127.78% | ― | 17.83% | 73.13% | |
41 Neutral | $3.29M | -0.27 | 5740.28% | ― | ― | ― | |
38 Underperform | $179.39K | >-0.01 | -1358.66% | 1.44% | ― | ― |
* Healthcare Sector Average
BFRI
Biofrontera
1.18
0.22
23.04%
PRPH
Prophase Labs
0.01
-4.42
-99.75%
TXMD
TherapeuticsMD
2.05
0.98
91.59%
RDHL
RedHill Biopharma
0.50
-1.34
-72.83%
COSM
Cosmos Holdings
0.35
-0.73
-67.50%
GELS
Gelteq Limited
0.55
-0.85
-61.00%
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...
Business Operations and StrategyExecutive/Board ChangesShareholder Meetings
Biofrontera Shareholders Approve Director Elections and Equity Plan
Positive
Jun 17, 2026
At its Annual Meeting of Stockholders held on June 11, 2026, Biofrontera Inc. shareholders elected Beth J. Hoffman, Ph.D., and Kevin D. Weber as Class II directors to serve until the 2029 annual meeting, reinforcing continuity in the company’...
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.