Overview
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- TickerBFRI on Nasdaq1
- IndustryPharmaceutical Preparations1
- HeadquartersWoburn, Massachusetts1
- Incorporated inDE2
- Business address120 Presidential Way,, Suite 330, Woburn, Ma 018012
- Filer category, Emerging growth company2
- Legal formCorporation
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Transaction”). See Note 3. Asset Acquisition and Note 16. Related Party Transactions for additional information.3 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Key numbers, fiscal 2025
-27.2%Operating margin4
-25.3%Net margin4
11.7%Revenue growth, 20254
-100.5%Return on equity4
-$13.4MFree cash flow4
Where the money goes
Where each dollar of revenue went, fiscal 2025
- Research and development9¢$3.7M
- Selling, general and admin91¢$37.8M
- Other costs1¢$210.0K
- Income tax0¢$25.0K
Out of $41.7M in revenue.4 The company lost money this year.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.4
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Product revenues, net | $41.7M | $37.3M |
| Revenues, related party | $18.0K | |
| Total revenues, net | $41.7M | $37.3M |
| Selling, general and administrative | $37.8M | $33.8M |
| Selling, general and administrative, related party | $619.0K | $42.0K |
| Research and development | $3.7M | $2.1M |
| Total operating expenses | $53.1M | $54.5M |
| Loss from operations | -$11.3M | -$17.2M |
| Change in fair value of warrant liabilities | $899.0K | $1.7M |
| Change in fair value of investment, related party | $2.0K | -$14.0K |
| Loss on debt extinguishment | -$316.0K | |
| Interest expense, net | -$452.0K | -$2.0M |
| Other income, net | $388.0K | $158.0K |
| Total other income (expense) | $837.0K | -$527.0K |
| Loss before income taxes | -$10.5M | -$17.7M |
| Income tax expense | $25.0K | $22.0K |
| Net loss | -$10.5M | -$17.8M |
| Basic | -$1.04 | -$3.22 |
| Diluted | -$1.04 | -$3.22 |
| Basic | 10.2M shares | 5.5M shares |
| Diluted | 10.2M shares | 5.5M shares |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 4 fiscal years (annual) or 4 quarters (quarterly), latest first.4
| Period ending | 2025-12-31 | 2025-06-30 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|---|
| Cash and cash equivalents | $6.4M | $5.9M | ||
| Investment, related party | $9.0K | $7.0K | ||
| Accounts receivable, net | $7.3M | $5.3M | ||
| Inventories | $1.4M | $6.6M | ||
| Prepaid expenses and other current assets | $2.3M | $527.0K | ||
| Asset held for sale | $2.3M | |||
| Total current assets | $18.1M | $20.7M | ||
| Inventories, long term | $3.7M | |||
| Property and equipment, net | $2.2M | $80.0K | ||
| Operating lease right-of-use assets | $1.6M | $903.0K | ||
| Intangible assets, net | $2.6M | $35.0K | ||
| Other assets | $360.0K | $383.0K | ||
| Total assets | $28.6M | $22.1M | ||
| Operating lease liabilities | $332.0K | $548.0K | ||
| Accrued expenses and other current liabilities | $4.9M | $4.3M | ||
| Total current liabilities | $11.9M | $12.0M | ||
| Convertible notes payable | $4.6M | $4.1M | ||
| Warrant liabilities | $351.0K | $1.2M | ||
| Operating lease liabilities, non-current | $1.2M | $276.0K | ||
| Other liabilities | $9.0K | $23.0K | ||
| Total liabilities | $18.1M | $17.7M | ||
| Common Stock, $0.001 par value, 70,000,000 shares authorized; 11,648,323 and 8,873,932 shares issued and outstanding as of December 31, 2025 and 2024, respectively | $12.0K | $9.0K | ||
| Additional paid-in capital | $138.4M | $121.8M | ||
| Accumulated deficit | -$127.9M | -$117.4M | ||
| Total stockholders equity | $10.5M | $4.4M | $4.8M | |
| Total liabilities and stockholders equity | $28.6M | $22.1M | ||
| Preferred stock par value, per share | $0.00 | $0.00 | $0.00 | |
| Preferred stock, shares authorized | 20.0M shares | 20.0M shares | 20.0M shares | |
| Common stock, par value | $0.00 | $0.00 | ||
| Common stock, shares authorized | 70.0M shares | 70.0M shares | 70.0M shares | |
| Common stock, shares issued | 11.6M shares | 8.9M shares | ||
| Common stock, shares outstanding | 11.6M shares | 8.9M shares |
| Period ending | 2025-12-31 | 2025-06-30 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|---|
| Cash and cash equivalents | $6.4M | $5.9M | ||
| Investment, related party | $9.0K | $7.0K | ||
| Accounts receivable, net | $7.3M | $5.3M | ||
| Inventories | $1.4M | $6.6M | ||
| Prepaid expenses and other current assets | $2.3M | $527.0K | ||
| Asset held for sale | $2.3M | |||
| Total current assets | $18.1M | $20.7M | ||
| Inventories, long term | $3.7M | |||
| Property and equipment, net | $2.2M | $80.0K | ||
| Operating lease right-of-use assets | $1.6M | $903.0K | ||
| Intangible assets, net | $2.6M | $35.0K | ||
| Other assets | $360.0K | $383.0K | ||
| Total assets | $28.6M | $22.1M | ||
| Operating lease liabilities | $332.0K | $548.0K | ||
| Accrued expenses and other current liabilities | $4.9M | $4.3M | ||
| Total current liabilities | $11.9M | $12.0M | ||
| Convertible notes payable | $4.6M | $4.1M | ||
| Warrant liabilities | $351.0K | $1.2M | ||
| Operating lease liabilities, non-current | $1.2M | $276.0K | ||
| Other liabilities | $9.0K | $23.0K | ||
| Total liabilities | $18.1M | $17.7M | ||
| Common Stock, $0.001 par value, 70,000,000 shares authorized; 11,648,323 and 8,873,932 shares issued and outstanding as of December 31, 2025 and 2024, respectively | $12.0K | $9.0K | ||
| Additional paid-in capital | $138.4M | $121.8M | ||
| Accumulated deficit | -$127.9M | -$117.4M | ||
| Total stockholders equity | $10.5M | $4.4M | $4.8M | |
| Total liabilities and stockholders equity | $28.6M | $22.1M | ||
| Preferred stock par value, per share | $0.00 | $0.00 | $0.00 | |
| Preferred stock, shares authorized | 20.0M shares | 20.0M shares | 20.0M shares | |
| Common stock, par value | $0.00 | $0.00 | ||
| Common stock, shares authorized | 70.0M shares | 70.0M shares | 70.0M shares | |
| Common stock, shares issued | 11.6M shares | 8.9M shares | ||
| Common stock, shares outstanding | 11.6M shares | 8.9M shares |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 2 fiscal years, latest first.4
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$10.5M | -$17.8M |
| Depreciation and amortization | $138.0K | $421.0K |
| Reduction in the carrying amount of right-of-use assets | $730.0K | $728.0K |
| Stock-based compensation | $951.0K | $1.0M |
| Non-cash interest expense | $491.0K | $297.0K |
| Allowance for credit losses | -$69.0K | $162.0K |
| Change in fair value of warrant liabilities | -$899.0K | -$1.7M |
| Gain on sale of asset held for sale | -$700.0K | |
| Loss from termination of operating leases | $19.0K | |
| Realized/unrealized loss in investment, related party | -$2.0K | $14.0K |
| Loss on debt extinguishment | $316.0K | |
| Accounts receivable | -$1.9M | -$315.0K |
| Other receivables, related party | $2.0K | |
| Prepaid expenses and other assets | -$1.7M | -$141.0K |
| Other assets, related party | -$686.0K | $5.2M |
| Inventories | $1.4M | $4.2M |
| Accounts payable | -$2.0K | -$1.5M |
| Accounts payable, related parties, net | -$533.0K | -$355.0K |
| Operating lease liabilities | -$683.0K | -$689.0K |
| Accrued expenses and other liabilities | $610.0K | -$230.0K |
| Cash flows used in operating activities | -$13.4M | -$10.3M |
| Proceeds from sale of asset held for sale | $3.0M | |
| Sales of investment, related party | $57.0K | |
| Purchase of intangible assets | -$50.0K | |
| Purchases of property and equipment | -$2.0K | -$10.0K |
| Cash flows provided by (used in) investing activities | $3.0M | -$3.0K |
| Proceeds from issuance of Series C preferred stock, net of offering costs | $10.8M | |
| Proceeds from issuance of Series B-1 preferred stock and warrants to purchase series B-3 preferred stock, net of issuance costs | $7.7M | |
| Proceeds from issuance of Series B-3 preferred stock from exercise of warrants | $7.4M | |
| Proceeds from issuance of convertible notes, net of issuance costs | $4.0M | |
| Payment of principal short-term debt | -$4.3M | |
| Cash flows provided by financing activities | $10.8M | $14.8M |
| Net increase in cash and cash equivalents | $487.0K | $4.6M |
| Interest paid | $6.0K | $1.7M |
| Income tax paid, net | $25.0K | $24.0K |
| Preferred stock issued as consideration in asset purchase acquisition (See Note 3. Asset Acquisition) | $4.8M | |
| Property, plant and equipment acquired | $2.1M | |
| Intangible asset acquired | $2.7M | |
| Addition of right-of-use assets in exchange for operating lease liabilities | $1.4M | $55.0K |
No quarter-by-quarter statement was filed.
Corporate structure
Biofrontera Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Biofrontera Inc.
- Rosalind Advisors, Inc. Filed SCHEDULE 13G/A on Biofrontera Inc., latest Aug 12, 2026 (11 filings since Mar 20, 2024)
- Orin Hirschman Filed SCHEDULE 13G/A on Biofrontera Inc., latest Jan 28, 2026 (3 filings since Mar 20, 2024)
- Balaton Aktiengesellschaft Deutsche Filed SCHEDULE 13D/A on Biofrontera Inc., latest Sep 19, 2025 (5 filings since Aug 25, 2022)
- Laurence W. Lytton Filed SCHEDULE 13G/A on Biofrontera Inc., latest May 15, 2025 (3 filings since Mar 20, 2024)
- ARMISTICE CAPITAL, LLC Filed SC 13G/A on Biofrontera Inc., latest Nov 14, 2024 (2 filings since Feb 14, 2024)
- Nabil Saad Filed SC 13G/A on Biofrontera Inc., latest Nov 13, 2024 (2 filings since Sep 12, 2024)
- Bigger Capital, LLC Filed SC 13G/A on Biofrontera Inc., latest Nov 1, 2024 (2 filings since Mar 15, 2024)
- Hewlett Fund LP Filed SC 13G on Biofrontera Inc., latest May 7, 2024
- Abshagen Consulting GmbH Filed SC 13G on Biofrontera Inc., latest Nov 4, 2022
- Biofrontera AG Filed SC 13G on Biofrontera Inc., latest Feb 10, 2022
- Biofrontera Inc. Woburn, Massachusetts
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Biofrontera Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, before depreciation | $2.4M4 Dec 31, 2025 | $693.0K4 Dec 31, 2024 | +249.9% |
| Accumulated depreciation | $267.0K4 Dec 31, 2025 | $613.0K4 Dec 31, 2024 | −56.4% |
| Property and equipment, net | $2.2M4 Dec 31, 2025 | $80.0K4 Dec 31, 2024 | +2597.5% |
| Operating-lease assets (leased space) | $1.6M4 Dec 31, 2025 | $903.0K4 Dec 31, 2024 | +75.4% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $6.4M4 Dec 31, 2025 | $5.9M4 Dec 31, 2024 | +8.2% |
| Equity securities at fair value | $9.0K4 Dec 31, 2025 | $7.0K4 Dec 31, 2024 | +28.6% |
Intangibles and goodwill
| Item | Latest | A year before | Change |
|---|---|---|---|
| Intangible assets, net (excluding goodwill) | $2.6M4 Dec 31, 2025 | $35.0K4 Dec 31, 2024 | +7471.4% |
| Accumulated amortization | $56.0K4 Dec 31, 2025 | $15.0K4 Dec 31, 2024 | +273.3% |
| Finite-lived intangibles, net | $2.6M4 Dec 31, 2025 | $35.0K4 Dec 31, 2024 | +7471.4% |
| Licenses, net | $4.6M8 Dec 31, 2024 | $4.6M7 Dec 31, 2023 | 0% |
Inventory
| Item | Latest | A year before | Change |
|---|---|---|---|
| Inventory, total | $1.4M4 Dec 31, 2025 | $6.6M4 Dec 31, 2024 | −78.5% |
| Finished goods | $1.4M4 Dec 31, 2025 | $6.6M4 Dec 31, 2024 | −78.5% |
Properties, in its own words
Our headquarters is located in Woburn, Massachusetts, where we lease approximately 11,400 square feet under a lease agreement with an initial term expiring in February 2031.
Item 2 of the 10-K filed Mar 19, 2026.3
Leadership
Who has led Biofrontera Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
Chief operating officer
2025
- Chief executive officerHermann Luebbert Oct 28, 2021 to Dec 13, 202111
- Chief executive officerErica L. Monaco Dec 13, 2021 to May 22, 202312
- ChairHermann Luebbert Jan 19, 2022 to now13
- Chief financial officerEugene Frederick Leffler Nov 4, 2022 to now14
- Chief financial officerErica L. Monaco Oct 28, 2021 to Oct 28, 202115
- Chief operating officerErica L. Monaco Oct 28, 2021 to Oct 28, 202115
Board members and other officers (10)
- Chief Commercial OfficerGeorge Patrick Jones Sep 16, 2025 to now16
- ControllerErica F. Gates Oct 28, 2021 to Jan 12, 202317
- Board memberAg Biofrontera Jul 9, 2025 to now18
- Board memberLa Huerta Martinez Maria Del Pilar De Sep 25, 2025 to now19
- Board memberHeikki Lanckriet Aug 22, 2023 to now20
- Board memberKevin Daniel Weber Mar 14, 2022 to now21
- Board memberErica L. Monaco Oct 28, 2021 to Oct 28, 202115
- Board memberHermann Luebbert Oct 28, 2021 to Oct 28, 202111
- Board memberJohn J. Borer Iii. Nov 2, 2021 to now22
- Board memberLoretta M. Wedge Nov 2, 2021 to Jun 6, 202223
Named in SEC Form D filings
People the company listed in its private-offering notices.
- DirectorBeth J. Hoffman named Dec 10, 2021 to Jul 11, 202524
Timeline
- Sep 14, 20268-K Other events25
- Aug 13, 20268-K Results of operations26
- Jun 17, 20268-K Shareholder vote27
- May 14, 20268-K Results of operations28
- Mar 19, 20268-K Results of operations29
- Mar 9, 20268-K Regulation FD disclosure30
- Feb 26, 20268-K Other events31
- Feb 9, 20268-K Regulation FD disclosure32
- Jan 13, 20268-K Results of operations33
- Jan 7, 20268-K Listing notice or transfer34
- Nov 13, 20258-K Results of operations35
- Nov 10, 20258-K Other events36
- Dec 13, 2021New chief executive Erica L. Monaco becomes CEO12
- Oct 28, 2021New chief executive Hermann Luebbert becomes CEO11
Calendar
Coming up
- Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.59) a share, on Nov 12, 2025.37
When it reported results
- Aug 13, 2026Reported quarterly or annual results26
- May 14, 2026Reported quarterly or annual results28
- Mar 19, 2026Reported quarterly or annual results29
- Jan 13, 2026Reported quarterly or annual results33
- Nov 13, 2025Reported quarterly or annual results35
- Aug 13, 2025Reported quarterly or annual results38
- May 15, 2025Reported quarterly or annual results39
- Mar 21, 2025Reported quarterly or annual results40
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
343 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 103 major events, 65 insider forms, 31 large holders, 7 private raises, 116 other. The latest 20:
- Sep 14, 20268-K EDGAR
- Aug 13, 202610-Q EDGAR
- Aug 13, 20268-K EDGAR
- Aug 12, 2026SCHEDULE 13G/A EDGAR
- Jul 29, 20264 EDGAR
- Jul 29, 20264 EDGAR
- Jul 22, 2026S-8 EDGAR
- Jul 22, 202610-K/A EDGAR
- Jun 17, 20268-K EDGAR
- May 14, 202610-Q EDGAR
- May 14, 20268-K EDGAR
- Apr 30, 2026DEF 14A EDGAR
- Mar 19, 202610-K EDGAR
- Mar 19, 20268-K EDGAR
- Mar 9, 20268-K EDGAR
- Mar 6, 20264 EDGAR
- Mar 6, 20264 EDGAR
- Mar 6, 20264 EDGAR
- Mar 6, 20264 EDGAR
- Mar 6, 20264 EDGAR
The 343 filings since October 2021 can be filtered by form type and year here when JavaScript is on.
Every filing from the last five years, summarized. The full record is on SEC EDGAR.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- Rosalind Advisors, Inc.SCHEDULE 13G/A, 11 filings Mar 20, 2024 to Aug 12, 202641
- Orin HirschmanSCHEDULE 13G/A, 3 filings Mar 20, 2024 to Jan 28, 202642
- Balaton Aktiengesellschaft DeutscheSCHEDULE 13D/A, 5 filings Aug 25, 2022 to Sep 19, 202543
- Laurence W. LyttonSCHEDULE 13G/A, 3 filings Mar 20, 2024 to May 15, 202544
- ARMISTICE CAPITAL, LLCSC 13G/A, 2 filings Feb 14, 2024 to Nov 14, 202445
- Nabil SaadSC 13G/A, 2 filings Sep 12, 2024 to Nov 13, 202446
- Bigger Capital, LLCSC 13G/A, 2 filings Mar 15, 2024 to Nov 1, 202447
- Hewlett Fund LPSC 13G, 1 filing May 7, 202448
- Abshagen Consulting GmbHSC 13G, 1 filing Nov 4, 202249
- Biofrontera AGSC 13G, 1 filing Feb 10, 202250
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
Funding
Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.
- Private raises (Form D) $58.4M
Figures by year
| Year | Private raises (Form D) | Total |
|---|---|---|
| 2025 | $11.0M | $11.0M |
| 2024 | $12.2M | $12.2M |
| 2022 | $20.2M | $20.2M |
| 2021 | $15.0M | $15.0M |
Private raises
Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.
- Jun 27, 2025Raised $11 million in a private offering of equity24 Form D: 5 investors so far Form D
- Nov 21, 2024Raised $4.2 million in a private offering of debt52 Form D: 5 investors so far Form D
- Feb 19, 2024Raised $8 million in a private offering of equity53 Form D: 8 investors so far Form D
- Oct 25, 2022Raised $3.7 million in a private offering of equity54 Form D: 1 investor so far Form D
- Jul 27, 2022Raised $7.1 million in a private offering of equity55 Form D: 1 investor so far Form D
- May 16, 2022Raised $9.4 million in a private offering of equity56 Form D: 1 investor so far Form D
- Nov 29, 2021Raised $15 million in a private offering of equity57 Form D: 1 investor so far Form D
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026. Change is in shares since the quarter before.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| Rosalind Advisors, Inc. | 1,275,609 | $1.2M | 0.5% | +111,647 |
| AIGH Capital Management LLC | 739,910 | $699.6K | 0.1% | −175,300 |
| Renaissance Technologies LLC | 157,505 | $148.9K | 0.0% | New |
| Citadel Advisors LLC | 104,941 | $99.2K | 0.0% | New |
| Jane Street Group, LLC | 93,000 | $87.9K | 0.0% | New |
| Geode Capital Management, LLC | 76,689 | $72.5K | 0.0% | −32,611 |
| Vanguard Capital Management LLC | 71,380 | $67.5K | 0.0% | +19,126 |
| Vanguard Fiduciary Trust Co | 61,697 | $58.4K | 0.0% | No change |
| XTX Topco Ltd | 51,894 | $49.1K | 0.0% | +29,401 |
| Northern Trust Corp | 31,536 | $29.8K | 0.0% | New |
| UBS Group AG | 18,518 | $17.5K | 0.0% | +16,978 |
| Jones Financial Companies Lllp | 10,000 | $9.7K | 0.0% | New |
| Sanctuary Advisors, LLC | 10,200 | $9.6K | 0.0% | No change |
| BlackRock, Inc. | 4,622 | $4.4K | 0.0% | No change |
| Tower Research Capital LLC (TRC) | 332 | $314 | 0.0% | New |
| SBI Securities Co., Ltd. | 305 | $288 | 0.0% | No change |
| Hrt Financial LP | 43,349 | $40 | 0.0% | New |
| Gsa Capital Partners Llp | 10,022 | $9 | 0.0% | New |
| Caitong International Asset Management Co., Ltd | 1 | $1 | 0.0% | New |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Biofrontera Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARBiofrontera Inc.1
- CIK0001858685
- Employer ID (EIN)47-37656753
- Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; a shell company3
- Incorporated inDelaware3
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address120 Presidential Way,, Suite 330, Woburn, MA 018011
- Phone781-245-13251
- Shares outstanding14,852,359 as of Aug 11, 202610
- Public float$6.9M as of Jun 30, 20253
- AuditorCBIZ CPAs P.C, Morristown, New Jersey PCAOB ID 199; no auditor attestation of internal control over financial reporting3
- On EDGAR sinceMay 7, 20211
- Filings364 in all: 8-K (99), 4 (40), CORRESP (28), 3 (19), S-1/A (16), UPLOAD (16), 10-Q (15), EFFECT (11)1
All 39 form types
S-1 (11), SC 13G (10), SCHEDULE 13G/A (9), 424B3 (8), DEF 14A (8), D (7), SC 13G/A (7), 4/A (6), 10-K (5), 8-K/A (4), DRS (4), DRSLTR (4), PRE 14A (4), DEFA14A (3), DEFR14A (3), S-8 (3), SCHEDULE 13D/A (3), 424B4 (2), 8-A12B (2), 8-A12B/A (2), DRS/A (2), FWP (2), POS EX (2), SEC STAFF LETTER (2), 10-K/A (1), CERT (1), NT 10-K (1), POS AM (1), RW (1), SC 13D (1), SC 13D/A (1)
- Latest filingsAnnual report (10-K) Mar 19, 2026
Quarterly report (10-Q) Aug 13, 2026
Proxy statement (DEF 14A) Apr 30, 2026
Latest 8-K (8-K) Sep 14, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.001 per share | BFRI | Nasdaq |
| Warrants for common stock | BFRIW | Nasdaq |
From the cover page of the 10-K filed Mar 19, 2026 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks Biofrontera Inc. names in Item 1A of its 10-K filed Mar 19, 2026: 39 risks under these headings, as written.3
- Risks Related to our Products
- Risks Related to Our Business and Strategy
- Risks Related to Our Financial Position and Capital Requirements
- Risks Related to Clinical Trials and Regulatory Approvals of Indication Expansion
- Risks Related to Corporate Governance, Including Being a Public Company
- Risks Related to Our Securities and the Ownership of Our Common Stock
- Risks Related to Our Products
- Generic versions of Ameluz may enter the market following the expiration of our patents, which may lead to significant reductions in the price of Ameluz and significant decreases in our market share.
- Our business depends substantially on the success of our principal product, Ameluz. If we are unable to successfully obtain and maintain regulatory approvals or reimbursement for Ameluz for existing and additional indications, our business may be materially harmed.
- If we or our manufacturing partners, as applicable, fail to manufacture Ameluz, RhodoLED Lamps, or other marketed products in sufficient quantities and at acceptable quality and cost levels, or to fully comply with cGMP or other applicable manufacturing regulations, we may face a bar to, or delays in, the commercialization of our products or be unable to meet market demand, and lose potential revenues.
- Breakdowns, failures, or suboptimal performance of our manufacturing equipment could disrupt operations, increase costs, impair product quality, and materially and adversely affect our business, financial condition, and results of operations.
- If our efforts to protect the proprietary nature of our intellectual property related to our products are not adequate, we may not be able to compete effectively in our market.
The other 34 risks
- We are and have been involved in intellectual property lawsuits related to our products and we may become involved in similar suits in the future, which could be expensive, time-consuming and unsuccessful.
- Our international dealings may pose currency risks, which may adversely affect our operating results and net income.
- Competing products and future emerging products may erode sales of our products.
- Geopolitical instability, trade disputes, and tariffs imposed on imports could materially increase our costs, disrupt our supply chain, and adversely affect our business, financial condition, and results of operations.
- Insurance coverage and medical expense reimbursement may be limited or unavailable in certain market segments for our products, including with respect to future indications of our products, which could make it difficult for us to sell our products.
- Healthcare legislative changes may have a material adverse effect on our business and results of operations.
- If we are unable to maintain effective marketing and sales capabilities or enter into agreements with third parties to market and sell our products, we may be unable to generate revenue growth.
- If we are unable to establish and maintain relationships with group purchasing organizations, our future revenues and/or future profitability could be jeopardized.
- The United States market size for Ameluz for the treatment of AK may be smaller than we have estimated.
- Even if we obtain additional regulatory approvals extending our products’ indications, they may not gain market acceptance or become widely accepted among hospitals, physicians, health care payors, patients and others in the medical community.
- We are subject to extensive laws and regulations. Our failure to comply with those laws and regulations could have a material adverse effect on our business, reputation, results of operations, and financial condition.
- A recall of our drug or medical device products, or the discovery of serious safety issues with our drug or medical device products, could have a significant negative impact on us.
- We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may be unable to successfully implement our business strategy.
- We will need to grow the size of our organization and we may experience difficulties in managing this growth.
- Our business and operations would suffer in the event of system failures or cyber-attacks.
- If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our products.
- Our subsidiary and certain third-party employees are subject to foreign laws.
- Third party claims of intellectual property infringement may affect our ability to sell our products and may also prevent or delay our product discovery and development efforts.
- The results of our R&D efforts are uncertain and there can be no assurance they will enhance the commercial success of our products.
- There is substantial doubt about our ability to continue as a “going concern”.
- We have a history of operating losses and anticipate that we will continue to incur operating losses in the future and may never sustain profitability.
- If we fail to obtain additional financing, we may be unable to pursue our plans for strategic growth.
- Our existing and any future indebtedness could adversely affect our ability to operate our business.
- Delay or termination of planned clinical trials for expanding the indications of Ameluz would result in unplanned expenses and significantly and adversely impact our remaining developmental activities and potential commercial prospects with respect to, and ability to generate revenues from, such indications.
- Our products may pose safety issues, cause adverse events, have side effects or have other properties that could delay or prevent the regulatory approval of additional indications, limit the commercial profile of an approved label or result in significant negative consequences following marketing approval, if any.
- The regulatory approval processes of the FDA are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for additional indications of our products on a timely basis or at all, our business could be substantially harmed.
- We rely on third parties to conduct some of our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to obtain regulatory approval to extend the indications of our products.
- If we fail to maintain an effective system of internal controls, our ability to produce timely and accurate financial statements may be impaired, investors may lose confidence in our financial reporting, and the price of our common stock may decline.
- Risks Related to Our Securities and Ownership of Our Common Stock
- Our share price may be volatile, and you may be unable to sell your shares and/or warrants at or above the offering price.
- If we fail to regain and maintain compliance with applicable listing standards, our common stock and publicly-traded warrants could be delisted from Nasdaq.
- We have issued several warrants, which are exercisable for our common stock, and issued Convertible Preferred Stock, which, if exercised or converted, as applicable, could substantially increase the number of shares eligible for future resale in the public market and result in dilution to our stockholders.
- Future sales and issuances of our common stock or rights to purchase our common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause the stock price of our common stock to decline.
- Certain provisions of our outstanding warrants, our charter documents, and Delaware law could prevent a takeover that stockholders consider favorable and could also reduce the market price of our stock.
- Many of the warrants to purchase shares of our common stock are accounted for as a warrant liability and recorded at fair value with changes in fair value each period reported in earnings, which may have an adverse effect on the market price of our common stock.
Legal proceedings
From time to time, we may be involved in legal proceedings arising in the ordinary course of our business. Information regarding our material legal proceedings is included in Note 22. Commitments and Contingencies, to the consolidated financial statements in Item 8 of this Form 10-K, which is incorporated herein by reference. Given the inherent uncertainties of litigation, the ultimate outcome of any such matters cannot be predicted at this time, nor can the amount of possible loss or range of loss, if any, be reasonably estimated, except in circumstances where an aggregate litigation accrual has been recorded for probable and reasonably estimable loss contingencies.
The opening of Item 3, Legal Proceedings.3
Sources
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- 13SEC EDGARHermann Luebbert, Chair
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- 17SEC EDGARErica F. Gates, Controller
- 18SEC EDGARAg Biofrontera, Board member
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- 20SEC EDGARHeikki Lanckriet, Board member
- 21SEC EDGARKevin Daniel Weber, Board member
- 22SEC EDGARJohn J. Borer Iii., Board member
- 23SEC EDGARLoretta M. Wedge, Board member
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- 25SEC EDGAROther events
- 26SEC EDGARResults of operations
- 27SEC EDGARShareholder vote
- 28SEC EDGARResults of operations
- 29SEC EDGARResults of operations
- 30SEC EDGARRegulation FD disclosure
- 31SEC EDGAROther events
- 32SEC EDGARRegulation FD disclosure
- 33SEC EDGARResults of operations
- 34SEC EDGARListing notice or transfer
- 35SEC EDGARResults of operations
- 36SEC EDGAROther events
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