FBIO

Fortress Biotech, Inc.

NASDAQ · HEALTH CARE · PHARMACEUTICAL PREPARATIONS

1.94

+0.07 +3.74%

USD · close Oct 27

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MKT CAP $160MP/E 0.7DIV YIELD —FCF YIELD —REV TTM $68.5M +15.5%NET INCOME $111.8MNET CASH $161.6M52W 1.87 – 4.38SEC XBRL · TTM TO Invalid Date

How FBIO rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

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Risk Factors” including, in particular, risks relating to: ● our growth strategy; ● financing and strategic agreements and relationships; ● our need for substantial additional funds and uncertainties relating to financings; ● uncertainty related to timing and amounts expected to be realized from future milestone, contingent value right, royalty or similar future revenue streams, if at all; ● our ability to identify, acquire, close and integrate product candidates successfully and on a timely basis; ● our ability to attract, integrate and retain key personnel; ● the early stage of product candidates under development; ● the results of research and development activities; ● uncertainties relating to preclinical and clinical testing; ● our ability to successfully commercialize products for which we receive regulatory approval; ● the ability to secure and maintain third-party manufacturing, marketing and distribution of our and our partner companies’ products and product candidates; ● government regulation; ● patent and intellectual property matters; and ● competition.
We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this Annual Report on Form 10-K should be read as applying mutatis mutandis to every other instance of such information appearing herein. SUMMARY OF RISK FACTORS Our business is subject to risks of which you should be aware before making an investment decision.
The risks described below are a summary of the principal risks associated with an investment in us and are not the only risks we face.
You should carefully consider these risk factors, the risk factors described in Item 1A, and the other reports and documents that we have filed with the Securities and Exchange Commission (“SEC”).
As used below and throughout this filing (including in the risk factors described in Item 1A), the words “we”, “us” and “our” may refer to Fortress Biotech, Inc. individually, to one or more of its subsidiaries and/or partner companies, or to all such entities as a group, as dictated by context. Risks Inherent in Drug Development ● Many of our product candidates are in early development stages and are subject to time and cost intensive regulation and clinical testing, which may result in the identification of safety or efficacy concerns.
As a result, our product candidates may never be successfully developed or commercialized. ● Our competitors may develop treatments for our products’ target indications, which could limit our product candidates’ commercial opportunity and profitability. Risks Pertaining to the Need for and Impact of Existing and Additional Financing Activities ● We have a history of operating losses and expect such losses to continue in the future. ● We have funded our operations in part through the assumption of debt, and our applicable lending agreements may restrict our operations.
Further, the occurrence of any default event under an applicable loan document could adversely affect our business. ● Our research and development (“R&D”) programs will require substantial additional capital, which we may be unable to raise as needed and which may impede our R&D programs, commercialization efforts, or planned acquisitions. ● Our board of directors has paused payments of dividends on our preferred stock, and there can be no assurance that monthly dividend payments will be resumed in a timely manner, or at all. ● If we raise additional capital by issuing equity, equity-linked securities or securities convertible into or exercisable for equity securities, our existing stockholders will be diluted. Risks Pertaining to Our Existing Revenue Stream from Journey Medical Corporation (“Journey”) ● Our operating income derives primarily from the sale of our partner company Journey’s dermatology products, particularly Emrosi, Qbrexza, Accutane, Amzeeq, Zilxi, Targadox, Exelderm, and Luxamend.
Any issues relating to the manufacture, sale, utilization, or reimbursement of Journey’s products (including products liability claims) could significantly impact our operating results. ● A significant portion of Journey’s sales derive from products that are without patent protection and/or are or may become subject to third party generic competition, the introduction of new competitor products, or an increase in market share of existing competitor products, any of which could have a significant adverse effect on our operating income.
Four of Journey’s marketed products, Emrosi, Qbrexza, Amzeeq and Zilxi , currently have patent protection.
Four of Journey’s marketed products, Accutane, Targadox, Exelderm, and Luxamend, do not have patent protection or otherwise are not eligible for patent protection.
With respect to Journey products that are covered by valid claims of issued patents, such patents may be subject to invalidation, which would harm our operating income. ● Continued sales and coverage, including formulary inclusion without the need for a prior authorization or step edit therapy, of our products for commercial sale will depend in part on the availability of reimbursement from third-party payors, including government payors.
Third-party payors are increasingly examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and efficacy, and, accordingly, significant uncertainty exists as to the reimbursement status of current and newly approved therapeutics. ● The Company’s business may be materially adversely affected by the imposition of duties and tariffs and other trade barriers and retaliatory countermeasures implemented by the U.S. and other governments. Risks Pertaining to Our Business Strategy, Structure and Organization ● We have entered, and will likely in the future enter, into certain collaborations or divestitures which may cause a reduction in our business’ size and scope, market share and opportunities in certain markets, or our ability to compete in certain markets and therapeutic categories. ● We and our subsidiaries and partner companies have also entered into, and intend in the future to enter into, arrangements under which we and/or they have agreed to contingent dispositions of such companies and/or their assets, including an asset purchase agreement between us, Cyprium and an undisclosed buyer to purchase Cyprium’s previously-issued priority review voucher (“PRV”) for $205 million, which was announced on March 30, 2026 as closed.
The failure to consummate any such transaction may impair the value of such companies and/or assets, and we may not be able to identify or execute alternative arrangements on favorable terms, if at all.
The consummation of any such arrangements with respect to certain product candidates may also result in our eligibility to receive a lower portion of sales (if any) of resulting approved products than if we had developed and commercialized such products ourselves. ● Our growth and success depend on our acquiring or in-licensing products or product candidates and integrating such products into our businesses. ● We may act as, and are likely to continue acting as, guarantor and/or indemnitor of certain obligations of our subsidiaries and partner companies, which could require us to pay substantial amounts in certain circumstances. Risks Pertaining to Reliance on Third Parties ● We rely heavily on third parties for several aspects of our operations, including manufacturing and developing product candidates, conducting clinical trials, and producing commercial product supply.
Such reliance on third parties reduces our ability to control every aspect of the drug development process and may hinder our ability to develop and commercialize our products in a cost-effective and timely manner. Risks Pertaining to Intellectual Property and Potential Disputes with Licensors Thereof ● If we are unable to obtain and maintain patent protection for our technologies and products, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technologies and products similar or identical to ours, and our ability to successfully commercialize our technologies and products may be impaired. ● We or our licensors may be subject to costly and time-consuming litigation for infringement of third-party intellectual property rights or to enforce our or our licensors’ patents. ● Any dispute with licensors may affect our ability to develop or commercialize our product candidates. Risks Pertaining to Generic Competition and Paragraph IV Litigation ● Generic drug companies may submit applications seeking approval to market generic versions of our products. ● In connection with these applications, generic drug companies may seek to challenge the validity and enforceability of our patents through litigation and/or with the United States Patent and Trademark Office (“PTO”).
Such challenges may subject us to costly and time-consuming litigation and/or PTO proceedings. ● As a result of the loss of any patent protection from such litigation or PTO proceedings, or the “at-risk” launch by a generic competitor of our products, our products could be sold at significantly lower prices, and we could lose a significant portion of product sales in a short period of time, which could adversely affect our business, financial condition, operating results and prospects. Risks Pertaining to the Commercialization of Product Candidates, if Approved ● If our product candidates, if approved, are not broadly accepted by the healthcare community, the revenues from any such products are likely to be limited. ● We may not obtain the desired product labels or intended uses for product promotion, or favorable scheduling classifications desirable to successfully promote our products. ● Even if a product candidate is approved, it may be subject to various post-marketing requirements, including studies or clinical trials, the results of which could cause such products to later be withdrawn from the market. ● Any successful products liability claim related to any of our current or future product candidates may cause us to incur substantial liability and limit the commercialization of such products. Risks Pertaining to Legislation and Regulation Affecting the Biopharmaceutical and Other Industries ● We operate in a heavily regulated industry, and we cannot predict the impact that any future legislation or administrative or executive action may have on our operations. General and Other Risks ● We have previously failed to satisfy certain continued listing rules of The Nasdaq Stock Market LLC (“Nasdaq”), and if we again are unable to meet the continued listing requirements and/or regain compliance with such rules, our Common Stock and Preferred Stock may be subject to delisting from The Nasdaq Capital Market.
The delisting of our Securities from the Nasdaq may decrease the market liquidity and market price of our Common Stock and Preferred Stock. PART I Item 1.
Fortress works in concert with our extensive network of key opinion leaders to identify and evaluate promising products and product candidates for potential acquisition.
We have executed arrangements in partnership with some of the world’s foremost universities, research institutes and pharmaceutical companies, including City of Hope National Medical Center (“COH” or “City of Hope”), Dana-Farber Cancer Institute, Nationwide Children’s Hospital, Columbia University, the University of Pennsylvania, AstraZeneca plc, Dr.
(“DRL”), and Sun Pharmaceutical Industries Limited (“Sun Pharma”).
Following the exclusive license or other acquisition of the intellectual property underpinning a product or product candidate, Fortress leverages its business, scientific, regulatory, legal and financial expertise to help its subsidiaries and partner companies achieve their goals.
To date, three partner companies are publicly-traded, and four subsidiaries have consummated strategic partnerships with industry leaders, including AstraZeneca plc as successor-in-interest to Alexion Pharmaceuticals, Inc.
(“AstraZeneca”), Sentynl Therapeutics, Inc.
Our subsidiary and partner companies that are pursuing development and/or commercialization of biopharmaceutical products and product candidates are: Journey Medical Corporation (Nasdaq: DERM, “Journey” or “JMC”), Mustang Bio, Inc.
“Checkpoint”), previously a partner company, was acquired by Sun Pharma in May 2025 (the “Checkpoint Acquisition”).
(“Baergic”), previously a subsidiary of Avenue, was acquired by Axsome in November 2025.
Additionally, this Annual Report on Form 10-K contains references to ClinicalTrials.gov identifiers.
However, information on ClinicalTrials.gov does not constitute part of this Annual Report on Form 10-K.
Recent Developments Checkpoint and UNLOXCYT In May 2025, our former subsidiary, Checkpoint, was acquired by Sun Pharma for $4.10 per share in cash plus a contingent value right of up to $0.70 per share upon the achievement of EU approval of Checkpoint’s principal drug product candidate (the “Checkpoint Acquisition”).
Pursuant to the Checkpoint Acquisition, Fortress received $28.0 million and is eligible to receive a 2.5% royalty on net sales of UNLOXCYT (cosibelimab-ipdl) as well as up to $4.8 million upon achievement of the contingent value right.
Journey and EMROSI (Minocycline Hydrochloride Extended-Release Capsules, 40mg) In November 2024, we announced that partner company Journey received approval of Emrosi (also referred to as DFD-29), a 40mg minocycline hydrochloride extended release capsule for oral use indicated to treat inflammatory lesions (papules and pustules) of rosacea in adults.
Subsequently, Journey announced the commercial launch of Emrosi in March 2025.
Cyprium and ZYCUBO (copper histidinate, also known as CUTX-101) In January 2025, we announced that the U.S.
Food and Drug Administration (“FDA”) had accepted the New Drug Application (“NDA”) for CUTX-101, a copper histidinate injection, for priority review for the treatment of Menkes disease and had set a Prescription Drug User Fee Act (“PDUFA”) target action date of September 30, 2025.
In October 2025, we announced that the FDA had issued a Complete Response Letter (“CRL”) to our partner Sentynl for CUTX-101.
The CRL noted cGMP deficiencies had been observed at the facility where CUTX-101 is manufactured and did not cite any other approvability concerns, nor did it identify any deficiencies in CUTX-101’s efficacy and safety data.
In December 2025, we announced the FDA accepted the resubmission of the NDA for CUTX-101 as a Class 1 resubmission with a new PDUFA target action date of January 14, 2026.
On January 13, 2026, we announced the FDA approved ZYCUBO (copper histidinate, also referred to as CUTX-101) for the treatment of pediatric patients with Menkes disease.
A Rare Pediatric Disease Priority Review Voucher (“PRV”) was issued in connection with FDA approval and, pursuant to Cyprium’s previous transaction with Sentynl, was transferred to Cyprium.

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Gone since FY2024

Risk Factors—Risks Pertaining to the Need for and Impact of Existing and Additional Financing Activities.” Stock Offerings and At-The-Market Share Issuances On May 17, 2024, the Company filed a shelf registration statement (File No. 333-279516) on Form S-3, which was declared effective on May 30, 2024 (the “2024 Shelf”).
For the year ended December 31, 2024, the Company issued and sold approximately 2.0 million shares of common stock at an average price of $1.98 per share for gross proceeds of $3.9 million.
In connection with these sales, the Company paid aggregate fees of $0.1 million.
As of December 31, 2024, $ 43.1 million of securities were available for sale under the 2024 Shelf, subject to General Instruction I.B.6. of Form S-3, known as the “baby shelf rules,” which limit the number of securities that can be sold under registration statements on Form S-3.
However, on July 5, 2024, our board of directors paused the payment of dividends on our Series A Preferred Stock until further notice.
As a result, we are no longer eligible to use Form S-3 and have lost the ability to use the 2024 Shelf.
In September 2024, Fortress closed a registered direct offering of an aggregate of 3,939,394 shares of its common stock at a purchase price of $1.65 per share.
In a concurrent private placement, the Company also agreed to issue to the same investors that participated in the registered direct offering warrants to purchase up to 3,939,394 shares of common stock (the “Private Placement Warrants”).
The Private Placement Warrants have an exercise price of $ 1.84 per share, are exercisable commencing six months from the date of issuance, and will expire five and one-half years following the date of issuance.
In a separate concurrent private placement, Dr.
Rosenwald, our Chairman, President and Chief Executive Officer, purchased 763,359 shares of common stock at a price of $1.84 per share, which represented the consolidated closing bid price of the Company’s common stock on the Nasdaq Capital Market on September 19, 2024, and warrants to purchase up to 763,359 shares of common stock, purchased at a price of $0.125 per warrant (the “Concurrent Private Placement Warrants”).
The Concurrent Private Placement Warrants have an exercise price of $ 1.84 per share, are exercisable commencing six months from the date of issuance, and will expire five and one-half years following the date of issue.
Net proceeds to Fortress from the September 2024 registered direct offering and the concurrent private placements, after deducting the placement agent’s fees and other offering expenses and assuming no exercises of the Private Placement Warrants or the Concurrent Private Placement Warrants, were approximately $ 7.3 million.
The Company filed a registration statement (No. 333-282384) on Form S-1 to register the resale of the shares of Common Stock issuable upon exercise of the Private Placement Warrants and the Concurrent Private Placement Warrants, which was declared effective by the SEC on October 7, 2024.
In January 2024, Fortress closed a registered direct offering of an aggregate of 3,303,305 shares of its common stock and warrants to purchase up to 3,303,305 shares of its common stock at a combined purchase price of $3.33 per share of common stock and accompanying warrant priced at-the-market under Nasdaq rules.
The warrants have an exercise price of $ 3.21 per share, were immediately exercisable, and expire five years following the date of issue.
Net proceeds to Fortress, after deducting the placement agent’s fees and other offering expenses, were approximately $ 10.1 million.
Journey In December 2022, Journey filed a shelf registration statement on Form S-3 (File No. 333-269079 ), which was declared effective in January 2023 (the “Journey 2022 S-3”).
This shelf registration statement covers the offering, issuance and sale by Journey of up to an aggregate of $150.0 million of Journey’s common stock, preferred stock, debt securities, warrants, and units.
For the year ended December 31, 2024, Journey issued approximately 1.6 million shares of common stock at an average price of $5.19 per share for net proceeds of $7.9 million after deducting aggregate fees of $0.2 million.
At December 31, 2024, 2,586,987 shares remain available for issuance under the Journey 2022 S-3.
Checkpoint In March 2023, Checkpoint filed a registration statement on Form S-3 (File No. 333-270843), which was declared effective May 5, 2023 (the “Checkpoint 2023 S-3”).
Under the Checkpoint 2023 S-3, Checkpoint may sell up to a total of $ 150 million of its securities.
As of December 31, 2024, approximately $ 65.7 million of the securities remain available for sale through the Checkpoint 2023 S-3.
In November 2024, Checkpoint received approximately $9.2 million upon the exercise of existing Series B warrants to purchase 3,256,269 shares of Checkpoint common stock, which warrants were originally issued and sold in a registered direct offering from May 2023 with an exercise price of $2.821 per share.
The shares of common stock issuable upon the exercise of the warrants were registered under the Checkpoint 2023 S-3. In July 2024, Checkpoint closed on a registered direct offering (the “Checkpoint July 2024 Registered Direct Offering”) for the issuance and sale of an aggregate of 1,230,000 shares of its common stock at a purchase price of $ 2.05 per share.
In addition, the offering includes 4,623,659 shares of common stock in the form of pre-funded warrants at a price of $ 2.0499 .
In a concurrent private placement, Checkpoint issued and sold common warrants (the “Checkpoint July 2024 Common Stock Warrants”) to purchase up to 5,853,659 shares of common stock.
The Checkpoint July 2024 Common Stock Warrants have an exercise price of $ 2.05 per share, will be exercisable after requisite approval of Checkpoint’s stockholders is received, and have a term of exercise of five years from the issuance date.
Checkpoint also issued the placement agent warrants to purchase up to 351,220 shares of common stock with an exercise price of $ 2.5625 per share.
The total net proceeds from the Checkpoint July 2024 Registered Direct Offering, after deducting placement agent’s fees and other offering expenses, were approximately $ 11.0 million.
The shares of common stock and the shares underlying the pre-funded warrants were sold in a registered offering under the Checkpoint 2023 S-3.
In August 2024, Checkpoint filed a registration statement on Form S-3 to register the public resale of the shares of Checkpoint common stock issuable upon exercise of each of the Checkpoint July 2024 Common Stock Warrants and the placement agent warrants, which was declared effective August 30, 2024 (File No. 333-281650).
All of the pre-funded warrants from the Checkpoint July 2024 Registered Direct Offering have been exercised.
In January 2024, Checkpoint closed on a registered direct offering (the “Checkpoint January 2024 Registered Direct Offering”) for the issuance and sale of 1,275,000 shares of its common stock at a purchase price of $1.805 per share.
In addition, the offering includes pre-funded warrants to purchase 6,481,233 shares of common stock , which were sold at a price of $ 1.8049 .
In a concurrent private placement, Checkpoint issued and sold common warrants (the “Checkpoint January 2024 Common Warrants”) to purchase up to 7,756,233 shares of Checkpoint common stock.
The Checkpoint January 2024 Common Warrants are exercisable immediately upon issuance and will expire five years following the issuance date and have an exercise price of $ 1.68 per share.
Checkpoint also issued the placement agent warrants to purchase up to 465,374 shares of common stock with an exercise price of $ 2.2563 per share.
Net proceeds to Checkpoint from the Checkpoint January 2024 Registered Direct Offering were $ 12.6 million after deducting commissions and other transaction costs.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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