1. Investment Snapshot
2. Thesis
3. Valuation & Price Target
4. Business & Product Moat
5. People & Governance
6. Market & Macro
7. Financial Quality
8. Risk Register
9. Prediction Market
10. 𝕏 Posts
Discussion
1. Investment Snapshot
2. Thesis
3. Valuation & Price Target
4. Business & Product Moat
5. People & Governance
6. Market & Macro
7. Financial Quality
8. Risk Register
9. Prediction Market
10. 𝕏 Posts
Discussion
1. Investment Snapshot
2. Valuation
Discussion
Symbol
BFRI
Event Date
2021-10-29
Sector
Health Care
Subsector
Pharmaceuticals
Offer Range
—
Shares Offered
3.6M
11.6M
$58.0M
31.0%
Implied Upside vs Midpoint
Description
We are a U.S.-based biopharmaceutical company specializing in the commercialization of pharmaceutical products for the treatment of dermatological conditions, in particular, diseases caused primarily by exposure to sunlight that result in sun damage to the skin. Our licensed products focus on the treatment of actinic keratoses, which are skin lesions that can sometimes lead to skin cancer. We also market a topical antibiotic for treatment of impetigo, a bacterial skin infection. Our principal licensed product is Ameluz®, which is a prescription drug approved for use in combination with our licensor’s medical device, which has been approved by the U.S. Food and Drug Administration (the “FDA”), the BF-RhodoLED® lamp, for photodynamic therapy, or PDT (when used together, “Ameluz® PDT”) in the United States for the lesion-directed and field-directed treatment of actinic keratosis of mild-to-moderate severity on the face and scalp. We are currently selling Ameluz® for this indication in the United States under an exclusive amended and restated license and supply agreement, or Ameluz LSA, by and among us, Biofrontera Pharma and Biofrontera Bioscience dated as of June 16, 2021, as amended. Under the Ameluz LSA, we hold the exclusive license to sell Ameluz® and the BF-RhodoLED® lamp in the United States for all indications currently approved by the FDA as well as all future FDA-approved indications that the Biofrontera Group may pursue. We have the authority under the Ameluz LSA in certain circumstances to take over clinical development, regulatory work and manufacturing from the Biofrontera Group, with respect to the FDA applications and clinical studies identified in the Corrected Amendment to the Ameluz LSA, if they are unable or unwilling to perform these functions appropriately. However, the Biofrontera Group does not have any obligation under the Ameluz LSA, as amended, to perform or finance clinical trials to promote new indications beyond those identified in the Corrected Amendment to the Ameluz LSA. As further described below, under the Ameluz LSA, further extensions of the approved indications for Ameluz® photodynamic therapy in the United States are anticipated. Our second prescription drug licensed product in our portfolio is Xepi® (ozenoxacin cream, 1%), a topical non-fluorinated quinolone that inhibits bacterial growth. Currently, no antibiotic resistance against Xepi® is known and it has been specifically approved by the FDA for the treatment of impetigo, a common skin infection, due to Staphylococcus aureus or streptococcus pyogenes. It is approved for use in adults and children 2 months and older. We are currently selling Xepi® for this indication in the United States under an exclusive license and supply agreement, or Xepi LSA, with Ferrer that was assumed by Biofrontera on March 25, 2019 through our acquisition of Cutanea. On March 25, 2019, we acquired Cutanea from Maruho Co., Ltd. In November 2018, Cutanea had just launched Xepi®, a prescription cream for the treatment of impetigo. The acquisition of Cutanea in March 2019 has enabled us to market an FDA-approved drug that had already been introduced in the U.S. market. We believe that Xepi® has the potential to be another innovative product with a large market potential in our portfolio. As a licensee, we rely on our licensors to conduct clinical trials in order to pursue extensions to the current product indications approved by the FDA. Currently, Biofrontera AG (through its wholly owned subsidiary Biofrontera Bioscience GmbH) has submitted applications to the FDA for the following indications with respect to our flagship licensed product Ameluz® and the BF-RhodoLED® lamp. These studies are all being pursued as part of the Investigational New Drug Application that Biofrontera AG submitted to the FDA in 2017 to investigate the treatment of superficial basal cell carcinoma with Ameluz® and BF-RhodoLED® and was subsequently amended to include the BF-RhodoLED® XL lamp. Clinical Phase Indication / Approval Product comments Pre-clinical I II III process Status BF-RhodoLED® PDT lamp with . FDA approval granted XL larger on October 21, 2021 illumination area(1) Ameluz® Actinic . Study completed and Keratosis: results discussed with Pharmacokinetics FDA; to be submitted study to FDA along with 3 tubes safety study Ameluz® in Actinic . Safety study using 3 combination Keratosis on tubes of Ameluz®; IRB with face & scalp(2) approval obtained; BF-RhodoLED® protocol registered XL with the FDA; clinical site initiation expected in Q4 2021 Ameluz® Superficial . Special protocol basal cell assessment by the FDA carcinoma(3) prior to study start, patient recruitment is ongoing, last patient in expected by end of 2022 Ameluz® Moderate to . IRB approval obtained; severe acne study protocol registered with FDA in October 2021; clinical site initiation planned for Q4 2021 (1) BF-RhodoLED® lamp was approved in 2016. FDA did not request any further clinical trials for BF-RhodoLED®-XL lamp. (2) Phase II and Phase III trials not required for label change. (3) Additional Phase I and Phase II trials not required, because Ameluz® is an approved drug. We have the authority under the Ameluz LSA with respect to each of the indications described in the table above (as well as certain other clinical studies identified in the Corrected Amendment to the Ameluz LSA) in certain circumstances to take over clinical development, regulatory work and manufacturing from the Biofrontera Group, if they are unable or unwilling to perform these functions appropriately. The Biofrontera Group may choose, but has no obligation under the Ameluz LSA, to seek FDA approval with respect to additional indications. The pursuit of any additional indications would need to be separately negotiated between us and the Biofrontera Group. We are unaware of any immediate or near-term plans of Ferrer for a U.S.-market focused development pipeline. --- We were incorporated in March 2015 and commenced operations in May 2016. Our first commercial licensed product launch was in October 2016. Our corporate headquarters are located at 120 Presidential Way, Suite 330, Woburn, Massachusetts 01801. Our telephone number is 781-245-1325. Our principal website address is www.biofrontera-us.com.
Biofrontera Inc. annual income statement and balance sheet, FY 2022 to FY 2025, as reported in SEC filings.
| Metric | FY 2022 | FY 2023 | FY 2024 | FY 2025 |
|---|---|---|---|---|
| Revenue | $28.7M | — | $37.3M | $41.7M |
| Operating income | ($18.6M) | — | ($17.2M) | ($11.3M) |
| Net income | ($640K) | — | ($17.8M) | ($10.5M) |
| Metric | FY 2022 | FY 2023 | FY 2024 | FY 2025 |
|---|---|---|---|---|
| Total assets | $50.9M | — | $22.1M | $28.6M |
| Total liabilities | $27.0M | — | $17.7M | $18.1M |
| Total equity | $23.9M | $4.8M | $4.4M | $10.5M |
| Cash & equivalents | $17.2M | — | $5.9M | $6.4M |