Fortress Biotech, Inc.
For the period ended Dec 31, 2024. Filed Mar 31, 2025.
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FY2024 · Filed Mar 31, 2025
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Notes to the Consolidated Financial Statements
- Organization and Description of Business
Fortress Biotech, Inc. (“Fortress” or the “Company”) is a biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holding and dividend and royalty revenue streams. Fortress works in concert with its extensive network of key opinion leaders to identify and evaluate promising products and product candidates for potential acquisition. The Company has executed such arrangements in partnership with some of the world’s foremost universities, research institutes and pharmaceutical companies, including City of Hope National Medical Center, Fred Hutchinson Cancer Center, Dana-Farber Cancer Institute, Nationwide Children’s Hospital, Columbia University, the University of Pennsylvania, AstraZeneca plc and Dr. Reddy’s Laboratories, Ltd.
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 finance expertise to help its subsidiaries and partner companies achieve their goals. Partner and subsidiary companies then assess a broad range of strategic arrangements to accelerate and provide additional funding to support research and development, including joint ventures, partnerships, out-licensings, sales transactions, and public and private financings. To date, four partner companies are publicly-traded, andthree subsidiaries have consummated strategic partnerships with industry leaders, including AstraZeneca plc as successor-in-interest to Alexion Pharmaceuticals, Inc. (“AstraZeneca”) and Sentynl Therapeutics, Inc. (“Sentynl”).
Our subsidiary and partner companies that are pursuing development and/or commercialization of biopharmaceutical products and product candidates are: Checkpoint Therapeutics, Inc. (Nasdaq: CKPT, “Checkpoint”), Journey Medical Corporation (Nasdaq: DERM, “Journey” or “JMC”), Mustang Bio, Inc. (Nasdaq: MBIO, “Mustang”), Avenue Therapeutics, Inc. (OTC: ATXI, “Avenue”), Baergic Bio, Inc. (“Baergic,” a subsidiary of Avenue), Cellvation, Inc. (“Cellvation”), Cyprium Therapeutics, Inc. (“Cyprium”), Helocyte, Inc. (“Helocyte”), Oncogenuity, Inc. (“Oncogenuity”) and Urica Therapeutics, Inc. (“Urica”).
As used throughout this filing, the words “we”, “us” and “our” may refer to Fortress individually, to one or more of its subsidiaries and/or partner companies, or to all such entities as a group, as dictated by context. Generally, “subsidiary” refers to a private Fortress subsidiary, “partner company” refers to a public Fortress subsidiary, and “partner” refers to an entity with whom one of the foregoing parties has a significant business relationship, such as an exclusive license or an ongoing product-related payment obligation. The context in which any such term is used throughout this document, however, may dictate a different construal from the foregoing.
Liquidity and Capital Resources
Since inception, the Company’s operations have been financed primarily through the sale of equity and debt securities, from the sale of subsidiaries/partner companies, and the proceeds from the exercise of warrants. The Company has incurred losses from operations and negative cash flows from operating activities since inception and expects to continue to incur losses from operations for the next several years as it continues to develop and commercialize its existing and new product candidates. The Company is also required to comply with the financial covenants in its loan agreement as described in Note 9. Current cash and cash equivalents of$20.9 million for Fortress and private subsidiaries primarily funded by Fortress (“Parent Entity”) are considered sufficient to fund the Parent Entity’s operations for at least 12 months following the date of filing of the Company’s Annual Report on 10-K. However, the Company will need to raise additional funding through strategic relationships, public or private equity or debt financings, sale of partner companies including Checkpoint as discussed in Note 20, grants or other arrangements to develop and prepare regulatory filings and obtain regulatory approvals for the existing and new product candidates, fund operating losses, and, if deemed appropriate, establish or secure through third parties manufacturing for the potential products, sales and marketing capabilities. If such funding is not available or not available on terms acceptable to the Company, the Company’s current development plans and plans for expansion of its general and administrative infrastructure may be curtailed. Fortress also has the ability, subject to
limitations imposed by Rule 144 of the Securities Act of 1933 and other applicable laws and regulations, to raise money from the sale of common stock of the public companies in which it has ownership positions.
- Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The Company’s consolidated financial statements have been prepared in conformity with GAAP. The Company’s consolidated financial statements include the results of the Company’s subsidiaries for which it has voting control but does not own 100% of the outstanding equity of the subsidiaries. For consolidated entities where the Company owns less than 100% of the subsidiary, but retains voting control, the Company records net loss attributable to non-controlling interests in its consolidated statements of operations and presents non-controlling interests as a component of stockholders’ equity on its consolidated balance sheets. All intercompany income and/or expense items are eliminated entirely in consolidation prior to the allocation of net gain/loss attributable to non-controlling interest, which is based on ownership interests as calculated quarterly for each subsidiary.
Reclassification
Certain prior period amounts have been reclassified to conform to the current period classification. The Company has historically included amortization of acquired intangible assets within cost of goods sold on the consolidated statement of operations. For the years ended December 31, 2024 and 2023, “Costs of goods sold – product revenue” as presented in the consolidated statement of operations was disaggregated into “Costs of goods sold – (excluding amortization of acquired intangible assets)” and “Amortization of acquired intangible assets”. This presentation has been conformed for all previous periods presented and has no impact on previously reported financial results.
Use of Estimates
The preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. The Company’s significant estimates include, but are not limited to, provisions for coupons, chargebacks, wholesaler fees, specialty pharmacy discounts, managed care rebates, product returns, inventory realization, valuation of intangible assets, useful lives assigned to long-lived assets and amortizable intangible assets, fair value of stock options and warrants, stock-based compensation, common stock issued to acquire licenses, accrued expenses and contingencies. Due to the uncertainty inherent in such estimates, actual results may differ from these estimates.
Revenue Recognition
The Company records and recognizes revenue in a manner that depicts the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The Company’s revenues primarily result from contracts with customers, which are generally short-term and have a single performance obligation – the delivery of product. The Company’s performance obligation to deliver products is satisfied at the point in time that the goods are received by the customer, which is when the customer obtains title to and has the risks and rewards of ownership of the products. The transaction price is the amount of consideration to which the Company expects to be entitled in exchange for transferring promised goods to a customer. The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both.
Many of the Company’s products sold are subject to a variety of deductions. Revenues are recorded net of provisions for variable consideration, including coupons, chargebacks, wholesaler fees, specialty pharmacy discounts, managed care rebates, product returns, and other deductions customary to the pharmaceutical industry. Accruals for these provisions are presented in the consolidated financial statements as reductions to gross sales in determining net sales and as a contra asset within accounts receivable, net (if settled via credit) and other current liabilities (if paid in cash). Amounts recorded for revenue deductions can result from a series of judgements about future events and uncertainties and can rely on estimates
and assumptions. The following section briefly describes the nature of the Company’s provisions for variable consideration and how such provisions are estimated:
Coupons — The Company offers coupons on products for qualified commercially-insured parties with prescription drug co-payments. Such product sales flow through both traditional wholesaler and specialty pharmacy channels. Coupons are processed and redeemed at the time of prescription fulfilment by the pharmacy. The majority of the coupon reserve accrual at the end of the period reflects expected redemptions for product in the distribution channel. The expected accrual reserve requires us to estimate the distribution channel inventory at period end, the expected redemption rates, and the cost per coupon claim that the Company expects to receive. The estimate of product remaining in the distribution channel is comprised of estimated inventory at the wholesaler as well as an estimate at the specialty pharmacies, which the Company estimates based upon historical ordering patterns. The estimated redemption rate is based on historical redemptions as a percentage of units sold. The cost per coupon is based on the coupon rate.
Chargebacks and Government Chargebacks —* *The Company sells a portion of its products indirectly through wholesaler distributors to contracted indirect customers and qualified government healthcare providers. The Company enters into specific agreements with or provides discounts to these indirect customers and entities to establish pricing for the Company’s products, and in turn, the indirect customers and entities independently purchase these products. The Company’s provision for chargebacks is based on expected sell-through levels by the Company’s wholesale customers to the indirect customers and estimated wholesaler inventory levels as well as historical chargeback rates. The Company continually monitors its reserve for chargebacks and adjusts the reserve accordingly when expected chargebacks differ from actual experience.
Wholesaler fees— The Company provides allowances to its wholesale customers for sales order management, data, and distribution services. The Company also pays administrative and other fees to certain wholesale customers consistent with pharmaceutical industry practices. The Company records a provision for these fees based on contracted rates. Assumptions used to establish the provision include contract sales volumes and average contract pricing. The Company regularly reviews the information related to these estimates and adjusts the provision accordingly.
Specialty Pharmacy Discounts —* *The Company has in place contractual arrangements with specialty pharmacies and provides for contractually agreed upon discounts. These discounts are recorded at the time of sale based on the customer’s contracted rate and recorded as a reduction of revenue.
Managed Care Rebates— The Company is subject to rebates in connection with its agreements with certain contracted commercial payers. The Company estimates its managed care rebates based on the Company’s estimated payer mix and the applicable contractual rebate rate. The Company’s accrual for managed care rebates is based on an estimate of future claims that the Company expects to receive, which considers an estimate for inventory in the distribution channel. The accrual is recognized at the time of sale, resulting in a reduction of gross product revenue.
Product Returns — Consistent with industry practice, the Company offers customers a right to return any unused product. The customer’s right of return commences six months prior to product expiration date and ends one year after product expiration date. Products returned for expiration are reimbursed at current wholesale acquisition cost or indirect contract price. The Company estimates the amount of its product sales that may be returned by the Company’s customers and accrues this estimate as a reduction of revenue in the period the related product revenue is recognized. The Company estimates products returns as a percentage of sales to its customers.
Collaboration Revenue
The Company’s collaboration revenue includes service revenue, license fees and future contingent milestone-based payments. Collaboration revenue is recognized for contracted R&D services performed for its customers over time. The Company measures its progress using an input method based on the effort expended or costs incurred toward the satisfaction of the Company’s performance obligation. The Company estimates the amount of effort to be expended, including the time it will take to complete the activities, or the costs that may be incurred in a given period, relative to the estimated total effort or costs to satisfy the performance obligation. This results in a percentage that is multiplied by the transaction price to determine the amount of revenue the Company recognizes each period subject to the constraint on
variable consideration. This approach requires the use of estimates and judgement. If the Company’s estimates or judgements change over the course of the collaboration, they may affect the timing and amount of revenue that is recognized in the current and future periods.
Fair Value Measurement
The Company follows accounting guidance on fair value measurements for financial assets and liabilities measured at fair value on a recurring basis. Under the accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability.
The accounting guidance requires fair value measurements be classified and disclosed in one of the following three categories:
| Level 1: | Quoted prices in active markets for identical assets or liabilities. |
| Level 2: | Observable inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace. |
| Level 3: | Unobservable inputs which are supported by little or no market activity and that are financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. |
The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.
Certain of the Company’s working capital assets and liabilities, including cash and cash equivalents, accounts receivable, accounts payable, accrued expenses, and other current liabilities, are not measured at fair value on a recurring basis but are recorded at amounts that approximate their fair value due to their liquid or short-term nature. The carrying value of our notes payable approximates their fair value as the interest rate is variable and approximates the market rate for loans with similar terms and risk characteristics.
Segment Reporting
The Company views its operations and manages its business in segments that align with the Company’s public subsidiaries with Fortress being comprised of the parent entity and the private subsidiaries, including intersegment revenue consisting of various fees paid by the subsidiaries to Fortress that are eliminated in consolidation. Each public subsidiary is a biopharmaceutical company focused on acquiring, developing, and commercializing assets in different therapeutic and disease areas. The Company’s chief operating decision maker (“CODM”) is its chief executive officer.
The CODM reviews profit and loss information for each segment to assess the performance of the Company and each of its public subsidiaries. The accounting policies of the segments are the same as those described in this Note 2. See Note 18 for segment information.
Cash and Cash Equivalents
The Company considers highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Cash and cash equivalents at December 31, 2024 and 2023, consisted of cash and certificates of deposit in institutions in the United States. The Company maintains its cash and cash equivalent balances with high-quality financial institutions and, consequently, the Company believes that such funds are currently adequately protected against credit risk. At times, portions of the Company’s cash and cash equivalents may be uninsured or in deposit accounts that exceed
Federal Deposit Insurance Corporation (“FDIC”) limits, though the Company customarily invests a significant portion of its cash in Insured Cash Sweep (“ICS”) accounts to maximize FDIC insurance coverage across its holdings. As of December 31, 2024, the Company had not experienced losses on these accounts, and management believes the Company is not exposed to significant risk on such accounts. The Company’s cash equivalents and investments may comprise money market funds that are invested in U.S. Treasury obligations, corporate debt securities, U.S. Treasury obligations and government agency securities.
Property and Equipment
Computer equipment, furniture and fixtures and machinery and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful life of each asset. Leasehold improvements are amortized over the shorter of the estimated useful lives or the term of the respective leases.
Assets Held for Sale
Assets held for sale represent assets that have met the criteria of “held for sale” accounting, as specified by Accounting Standards Codification (“ASC”) 360, “Long-lived Assets.” As of December 31, 2024, there were$1.2 million of lab and cell processing equipment, furniture and fixtures and computer equipment that are recorded as assets held for sale. The effect of suspending depreciation on the assets held for sale is immaterial to the results of operations. The assets held for sale are part of Mustang’s repurchase of assets from uBriGene (Boston) Biosciences, Inc. (“uBriGene”) (see Note 3).
Intangible Assets
The Company’s finite-lived intangible assets consist of intangible assets acquired by Journey. Intangible assets are reported at cost, less accumulated amortization and impairments. Intangible assets with finite lives are amortized over their estimated useful lives, which represents the estimated life of the product. Amortization is calculated primarily using the straight-line method.
During the ordinary course of business, the Company has entered into certain licenses and asset purchase agreements. Potential milestone payments for achieving sales targets or regulatory development milestones are recorded when it is probable of achievement. Upon a milestone being achieved, the milestone payment will be capitalized and amortized over the remaining useful life for approved products and expensed for milestones prior to FDA approval. Royalty payments for approved products are recorded as cost of goods sold as sales are recognized.
Impairment of Long-Lived Assets
The Company reviews long-lived assets, including intangible assets with finite useful lives, for impairment at least annually or whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable (a “triggering event”). Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the long-lived asset in relation to expectations, significant negative industry or economic trends, and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset group for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset group to its carrying value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset group are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset group over its fair value, determined based on discounted cash flows. During the year ended December 31, 2024, Mustang recorded an asset impairment charge of $3.7 million (see Note 5). During the year ended December 31, 2023, Journey recorded an asset impairment charge of $3.1 million (see Note 8).
Restricted Cash
The Company records cash held in trust or pledged to secure certain debt obligations as restricted cash. As of December 31, 2024 and 2023, the Company had $1.6 million and $2.4 million, respectively, of restricted cash representing
pledges to secure letters of credit in connection with certain office leases and an undertaking posted by Cyprium to secure potential damages in an injunctive proceeding.
The following table provides a reconciliation of cash, cash equivalents, and restricted cash from the consolidated balance sheets to the consolidated statements of cash flows as of the dates presented:
| · · · · · · | ||||
|---|---|---|---|---|
| · · December 31, | ||||
| | | 2024 | | 2023 |
| Cash and cash equivalents | $57,263 | $80,927 | ||
| Restricted cash | | 1,552 | | 2,438 |
| Total cash and cash equivalents and restricted cash | | $58,815 | | $83,365 |
Inventories
The Company’s inventory consists of raw materials, work-in-process and finished goods supporting Journey’s sales of dermatology products. Inventories are recorded at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis. The Company periodically reviews the composition of inventory in order to identify excess, obsolete, slow-moving or otherwise non-saleable items taking into account anticipated future sales compared with quantities on hand, and the remaining shelf life of goods on hand. If non-saleable items are observed and there are no alternate uses for the inventory, the Company records a write-down to net realizable value in the period that the decline in value is first recognized. The Company’s inventory reserves were $0.5 million and $0.3 million at December 31, 2024 and 2023, respectively.
Accounts Receivable, Net
The Company’s accounts receivable consists of amounts due from customers to Journey related to dermatological product sales and have payment terms. For certain customers, the accounts receivable for the customer are net of prompt payment or specialty pharmacy discounts. The Company monitors the financial performance and creditworthiness of its customers so that it can properly assess and respond to changes in their credit profile. The Company reserves against accounts receivable for estimated losses that may arise from a customer’s inability to pay, and any amounts determined to be uncollectible are written off against the reserve when it is probable that the receivable will not be collected. The Company has historically not experienced significant credit losses. The allowance for doubtful accounts was $0.6 million and $0.5 million at December 31, 2024 and 2023, respectively.
Research and Development
Research and development costs are expensed as incurred. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. Upfront and milestone payments due to third parties that perform research and development services on the Company’s behalf will be expensed as services are rendered or when the milestone is achieved.
Research and development costs primarily consist of personnel related expenses, including salaries, benefits, travel, and other related expenses, stock-based compensation, payments made to third parties for license and milestone costs related to in-licensed products and technology, payments made to third party contract research organizations for preclinical and clinical studies, investigative sites for clinical trials, consultants, the cost of acquiring and manufacturing clinical trial materials, and costs associated with regulatory filings, laboratory costs and other supplies.
In accordance with ASC 730-10-25-1,Research and Development, costs incurred in obtaining technology licenses are charged to research and development expense if the technology licensed has not reached commercial feasibility and has no alternative future use. Such licenses purchased by the Company require substantial completion of research and development, regulatory and marketing approval efforts in order to reach commercial feasibility and has no alternative future use. Accordingly, the total purchase price for the licenses acquired is reflected in research and development – licenses acquired in the Company’s Consolidated Statements of Operations.
Accrued Research and Development Expense
The Company records accruals for estimated costs of research, preclinical, clinical and manufacturing development within accrued expenses which are significant components of research and development expenses. A substantial portion of the Company’s ongoing research and development activities is conducted by third-party service providers. Costs incurred under agreements with these third parties are accrued based on estimates of actual work completed in accordance with the respective agreements. Estimated costs are determined through discussions with internal personnel and external service providers as to the progress, or stage of completion or actual timeline (start-date and end-date) of the services and the agreed-upon fees to be paid for such services. Payments made to third parties under these arrangements in advance of the performance of the related services are recorded as prepaid expenses until the services are rendered.
If the actual timing of the performance of services or the level of effort varies from the estimate, accrued expenses or prepaid expenses are adjusted accordingly, which impact research and development expenses. Estimates are not expected to be materially different from amounts actually incurred, understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period.
Contingencies
The Company records accruals for contingencies and legal proceedings expected to be incurred in connection with a loss contingency when it is probable that a liability has been incurred and the amount can be reasonably estimated.
If a loss contingency is not probable but is reasonably possible, or is probable but cannot be estimated, the nature of the contingent liability, together with an estimate of the range of possible loss if determinable and material, would be disclosed.
Warrants
The Company and its subsidiaries have issued freestanding warrants to purchase shares of common stock in connection with financing activities (see Note 13) and accounts for them in accordance with applicable accounting guidance as either liabilities or as equity instruments depending on the specific terms of the warrant agreements. Warrants classified as liabilities are remeasured each period they are outstanding. Any resulting gain or loss related to the change in the fair value of the warrant liability is recognized in change in fair value of warrant liabilities (see Note 6), a component of other income (loss), in the consolidated statements of operations.
Leases
The Company accounts for its leases under ASC 842,Leases. Under this guidance, arrangements meeting the definition of a lease are classified as operating or financing leases and are recorded on the consolidated balance sheet as both a right-of-use asset and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company's incremental borrowing rate. Lease liabilities are increased by interest and reduced by payments each period, and the right-of-use asset is amortized over the lease term. For operating leases, interest on the lease liability and the amortization of the right-of-use asset result in straight-line rent expense over the lease term. For finance leases, interest on the lease liability and the amortization of the right-of-use asset results in front-loaded expense over the lease term. Variable lease expenses are recorded when incurred.
In calculating the right-of-use asset and lease liability, the Company elects to combine lease and non-lease components.
Issuance of Debt and Equity
Fortress and its partner companies and subsidiaries issue complex financial instruments which include equity and/or debt features. We analyze each instrument under ASC 480,Distinguishing Liabilities from Equity, ASC 815,Derivatives and Hedging and, ASC 470,Debt, in order to establish whether such instruments should be classified as debt or equity in the financial statements, and whether they include any embedded derivatives.
We accounted for the debt with Oaktree with detachable warrants in accordance with ASC 470,Debt, and assessed the classification of the common stock purchase warrants issued in connection with such transactions and determined that such instruments met the criteria for equity classification. The note proceeds were allocated between the Oaktree note and the warrants on a relative fair value basis.
The Company recorded the related issue costs and value ascribed to the warrants as a debt discount of the 2024 Oaktree Note (see Note 9). The discount is being amortized utilizing the effective interest method over the term of the 2024 Oaktree Note, which is approximately 15.39% at December 31, 2024.
Stock-Based Compensation
The Company expenses stock-based compensation to employees and non-employees over the requisite service period based on the estimated grant-date fair value of the awards and forfeitures, which are recorded upon occurrence. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model. The assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment.
Income Taxes
The Company accounts for income taxes under ASC 740,Income Taxes (“ASC 740”). ASC 740 requires the recognition of deferred tax assets and liabilities for both the expected impact of differences between the financial statement and tax basis of assets and liabilities and for the expected future tax benefit to be derived from tax loss and tax credit carry forwards. ASC 740 additionally requires a valuation allowance to be established when it is more likely than not that all or a portion of deferred tax assets will not be realized.
ASC 740 also clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. ASC 740 also provides guidance on de-recognition, classification, interest and penalties, accounting in interim period, disclosure and transition. Based on the Company’s evaluation, as of December 31, 2024 and December 31, 2023, the Company has recorded a liability related to an uncertain tax position of $0.9 million and $0.8 million, respectively. The 2021 through 2023 tax years are the only periods subject to examination upon filing of appropriate tax returns. The Company believes that its income tax positions and deductions would be sustained on audit and does not anticipate any adjustments that would result in a material change to its financial position.
The Company’s policy for recording interest and penalties associated with audits is to record such expense as a component of income tax expense. As of December 31, 2024 and December 31, 2023, the Company accrued interest related to uncertain tax positions of $0.2 million and $0.1 million, respectively. Management is currently unaware of any issues under review that could result in significant payments, accruals or material deviations from its position.
Net Loss Per Common Share
Basic and diluted net loss per share attributed to common stockholders is calculated by dividing the net loss attributed to Fortress (less the Series A Preferred Dividend declared and paid and/or cumulated, and Fortress’ share of subsidiary deemed dividends) by the weighted-average number of shares of Common Stock outstanding during the period, not including unvested restricted stock, and without consideration for other potentially dilutive securities. Diluted net loss per share is the same as the basic loss per share due to net losses incurred in all periods.
Non-Controlling Interests
The Company records net loss attributable to non-controlling interests in its consolidated statements of operations and presents non-controlling interests as a component of stockholders’ equity on its consolidated balance sheets. All intercompany income and/or expense items are eliminated entirely in consolidation prior to the allocation of net gain/loss
attributable to non-controlling interest, which is based on a quarterly calculation of ownership interests for each relevant subsidiary.
Subsidiary preferred shares and Class A common shares, if issued, are included in the ownership calculation on a 1:1 basis consistent with how the relevant contractual agreements provide for the allocation and distribution of earnings. These shares, if any, are convertible at Fortress’ election on a 1:1 basis into common stock (with adjustments for stock splits, if any) and upon conversion would have the same voting rights as the common stock. Only preferred stock and Class A common stock held by Fortress have majority voting rights, which rights would terminate upon conversion into common stock. The Company allocates the subsidiaries’ net loss/income to the non-controlling interest on a quarterly basis, and the calculation of non-controlling interest ownership percentage is determined as the average of the prior quarter and the current quarter’s non-controlling ownership interest.
The Company continually assesses whether changes to existing relationships or future transactions may result in the consolidation or deconsolidation of subsidiaries and/or partner companies.
Comprehensive Loss
The Company’s comprehensive loss is equal to its net loss for all periods presented.
Recent Accounting Pronouncements
In November 2023, the FASB issued ASU No. 2023-07,Segment Reporting (Topic 280):* Improvements to Reportable Segment Disclosures* The amendments in ASU 2023-07 improve reportable segment disclosure requirements through enhanced disclosures about significant segment expenses. The amendments introduce a new requirement to disclose significant segment expenses regularly provided to the chief operating decision maker (“CODM”), extend certain annual disclosures to interim periods, clarify that single reportable segment entities must apply ASC 280 in its entirety, permit more than one measure of segment profit or loss to be reported under certain conditions, and require disclosure of the title and position of the CODM. This guidance is effective for fiscal years, beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The Company adopted this new standard for its consolidated financial statements for the year ended December 31, 2024. The Company’s adoption of this guidance resulted in increased disclosures in the notes to the financial statements.
In December 2023, the FASB issued ASU 2023-09,Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which expands disclosures in an entity’s income tax rate reconciliation table and disclosures regarding cash taxes paid both in the U.S. and foreign jurisdictions. The update will be effective for annual periods beginning after December 15, 2024. The Company is currently evaluating the impact of the new standard on its consolidated financial statement disclosures.
In November 2024, the FASB issued ASU No. 2024-03,Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires new financial statement disclosures in tabular format, in the notes to financial statements, of specified information about certain costs and expenses. The amendments in this update do not change or remove current expense disclosure requirements. The amendments in this update are effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The Company is currently evaluating the impact of the new standard on its financial statement disclosures.
3. Asset Purchase Agreements
Mustang
Agreements with uBriGene (Boston) Biosciences, Inc. (“uBriGene”)
On May 18, 2023, Mustang entered into an Asset Purchase Agreement (the “Original Asset Purchase Agreement”) with uBriGene, pursuant to which Mustang agreed to sell its leasehold interest in its cell processing facility located in Worcester,
Massachusetts (the “Facility”), and associated assets relating to the manufacturing and production of cell and gene therapies at the Facility to uBriGene (the “Transaction”). Mustang and uBriGene subsequently entered into Amendment No. 1 to the Original Asset Purchase Agreement, dated as of June 29, 2023 (“Amendment No. 1”), and Amendment No. 2 to the Original Asset Purchase Agreement, dated as of July 28, 2023 (“Amendment No. 2,” and together with the Original Asset Purchase Agreement and Amendment No. 1, the “Prior Asset Purchase Agreement”).
On July 28, 2023, pursuant to the Prior Asset Purchase Agreement, Mustang completed the sale of all of its assets that primarily relate to the manufacturing and production of cell and gene therapies at the Facility (such operations, the “Transferred Operations” and such assets, the “Transferred Assets”) to uBriGene for upfront consideration of $6 million cash (the “Base Amount”). The Transferred Assets included all of Mustang’s assets, except for Mustang’s lease and related leasehold improvements of the Facility and contracts that are primarily used in the Transferred Operations. Mustang recorded a gain of $1.4 million in connection with the sale of the Transferred Assets and recorded approximately $0.3 million of the base consideration as deferred income, that was to be recognized upon the transfer of the lease.
In connection with the Prior Asset Purchase Agreement, Mustang and uBriGene submitted a voluntary joint notice to the U.S. Committee on Foreign Investment in the United States (“CFIUS”). Following CFIUS’s review and subsequent investigation of the transactions related to the Prior Asset Purchase Agreement, on May 13, 2024, Mustang, together with uBriGene and CFIUS, executed a National Security Agreement (the “NSA”), pursuant to which Mustang and uBriGene agreed to abandon the transactions related to the Prior Asset Purchase Agreement and the agreements entered into in connection therewith. The NSA obligated uBriGene and Mustang to terminate agreements between the two parties, including the Manufacturing Services Agreement, Quality Services Agreement, and Subcontracting CDMO Agreement. In addition, uBriGene must sell, or otherwise dispose of, the equipment assets purchased within 180 days after the execution of the NSA.
June 2024 Repurchase of Assets
On June 27, 2024 (the “Effective Date”), Mustang entered into an Asset Purchase Agreement (the “Repurchase Agreement”) with uBriGene, pursuant to which Mustang agreed, subject to the terms and conditions set forth therein, to repurchase the Transferred Assets, primarily lab equipment and supplies (collectively, the “Repurchased Assets”). Pursuant to the terms of the Repurchase Agreement, Mustang and uBriGene also terminated existing manufacturing and services agreements.
As consideration for the Repurchase Agreement, Mustang has agreed to pay to uBriGene a total purchase price (the “Purchase Price”) of $1.4 million, consisting of (i) an upfront payment of $0.1 million due within five (5) business days of the Effective Date and a (ii) subsequent amount of $1.3 million due on the date that is twelve (12) months after the closing date (the “Deferred Amount”). In the event that as of the original (or any extended) date on which the Deferred Amount is payable, Mustang has, as of the date of the public reporting of its then-most recent quarterly audited or unaudited financial statements, net assets below $20 million, then Mustang may, upon written notice to uBriGene, elect to delay its payment obligation of the Deferred Amount by an additional six (6) months, with no limit on the number of such extensions available to Mustang. Notwithstanding the foregoing, if Mustang has not paid the Deferred Amount in full as of the date that is twelve (12) months after closing of the Repurchase Agreement, any amounts that remain outstanding will accrue interest at a rate of 5% per annum beginning on the date that is twelve (12) months after closing and until the Deferred Amount is paid in full. Additionally, in connection with the termination of the agreements described above under the Repurchase Agreement, Mustang agreed to forgive a net receivable from uBriGene of approximately $3.3 million, comprised of outstanding receivables of $6.9 million and payables of $3.6 million, resulting in total purchase consideration in the Repurchase Transactions of approximately $4.7 million. The upfront payment of $0.1 million was paid in July 2024, and as of December 31, 2024, the $1.3 million Deferred Amount was recorded in Accrued Expenses - Other (see Note 10).
Mustang allocated the total purchase consideration of $4.7 million to the Repurchased Assets on a relative fair value basis. Mustang used a third-party to perform a valuation of the repurchased equipment, which resulted in a fair value less costs to sell of approximately $2.2 million. The remaining purchase consideration of $2.5 million was allocated to the supplies repurchased. The supplies repurchased with no alternative future use were recognized as research and development expense in an amount of $2.2 million. Repurchased supplies with an alternative future use of $0.3 million were also recognized in research and development expense, as Mustang does not have plans to resume operations in the facility, and
it intends to dispose of the supplies in a single transaction with the equipment. Mustang concluded that the disposal group, which includes the repurchased equipment assets and associated supplies with an aggregate value of approximately $2.2 million, met the criteria to be classified as held for sale at the date of acquisition. As of December 31, 2024, the disposal group continues to be held for sale at an approximate value of $1.2 million (see Note 5).
Cyprium
Agreement with Sentynl
On February 24, 2021, Cyprium entered into a development and asset purchase agreement (the “Sentynl APA”) with Sentynl, a U.S.-based specialty pharmaceutical company owned by the Zydus Group. Under the Sentynl APA, Sentynl provided $8.0 million of upfront development funding for Cyprium’s CUTX-101 program, with Cyprium remaining in control of development of such program; upon approval of the NDA for CUTX-101 by the FDA, Cyprium would be obligated to assign the NDA and certain other assets pertaining to the CUTX-101 program to Sentynl, after which point Sentynl would commercialize the drug and owe Cyprium royalties and regulatory and sales milestones.
The Sentynl APA contained an alternative “Approval Deadline Transfer” mechanism pursuant to which, in the event that CUTX-101 NDA approval had not been obtained by September 30, 2023, then Sentynl could elect, during the subsequent 45-day period, to assume control over development of CUTX-101 by effecting a Closing under the Sentynl APA. Cyprium received notice of Sentynl’s election to effect the Approval Deadline Transfer during such 45-day period, and the Closing of such transfer occurred in December 2023. The Approval Deadline Transfer obligated Sentynl to pay Cyprium $4.5 million in connection with the Closing, which was received by Cyprium in December 2023 and recorded as collaboration revenue by Fortress in its consolidated statements of operations for the year ended December 31, 2023. There were no further obligations required by Cyprium in regards to the $4.5 million.
Following such Closing, Sentynl is obligated to use commercially reasonable efforts to develop and commercialize CUTX-101, including the funding of the same. Additionally, Cyprium remains eligible to receive up to $129 million in aggregate development and sales milestones under the Agreement, and royalties on net sales of CUTX-101 as follows: (i)3% of annual net sales up to $75 million; (ii)8.75% of annual net sales between $75 million and $100 million; and (iii)12.5% of annual net sales in excess of $100 million. Cyprium will retain 100% ownership over any FDA priority review voucher that may be issued at NDA approval for CUTX-101.
With respect to the $8.0 million upfront payment from Sentynl received in 2021, the Company recognized revenue over the period in which the development activities occurred using an input method based upon the costs incurred to date in relation to the total estimated costs to complete the development activities. As of the date of the Approval Deadline Transfer, the revenue related to the upfront payment has been fully recognized. For the year ended December 31, 2023, the Company recognized revenue from this arrangement of $0.7 million.
In December 2024, the NDA for CUTX-101 was accepted by the FDA. The NDA, which has been granted Priority Review, has an assigned Prescription Drug User Fee Act (“PDUFA”) target action date of September 30, 2025. Cyprium received a milestone payment of $1.5 million from Sentynl that was due upon NDA acceptance, which was recorded as collaboration revenue by Fortress in its Consolidated Statements of Operations for the year ended December 31, 2024.
Urica Therapeutics, Inc. (“Urica”)
Agreement with Crystalys Therapeutics, Inc (“Crystalys”)
On July 15, 2024, Urica entered into an asset purchase agreement (the “APA”), royalty agreement (the “Royalty Agreement”), and related agreements (collectively, the “Transaction Documents”) with Crystalys, a Delaware corporation incorporated in 2022 and seeded by life sciences institutional investors. Under the Transaction Documents, Urica sold the rights to its URAT1 inhibitor product candidate (see Note 7) in development for the treatment of gout, dotinurad, and related intellectual property, licenses and agreements to Crystalys. In return, Crystalys issued to Urica shares of its common stock equal to 35% of Crystalys’ outstanding equity. Urica’s equity position cannot be reduced below 15% of Crystalys’ fully-diluted equity capitalization until it raises $150 million in equity securities.
The Transaction Documents also grant Urica a secured three percent (3%) royalty on future net sales of dotinurad to be paid by Crystalys, as well as the right to receive $0.6 million cash reimbursement for certain clinical and development costs incurred by Urica related to dotinurad. Urica has the right to appointone director to the board of directors of Crystalys, as well as an additional board observer. Crystalys is obliged to use commercially reasonable efforts to develop and commercialize dotinurad.
The APA also gives Urica the right, but not the obligation, to repurchase the sold assets for a repurchase price not to exceed $6.4 million plus accrued interest; in the event that Crystalys has not consummated a qualified financing of at least $120 million before January 8, 2026. Urica recorded a liability for the $0.6 million received, which will be accreted up to the repurchase price over the term of the repurchase option, and will not recognize an asset for its ownership interest received in Crystalys until the expiration of the repurchase option. Accordingly, for the year ended December 31, 2024, Urica recorded accretion of $0.7 million of the repurchase option price, booked to interest expense in the condensed consolidated statement of operations.
Aevitas
Agreement with 4DMT
On April 21, 2023, Aevitas entered into an Asset Purchase Agreement (the “4DMT APA”) with 4DMT under which 4DMT acquired Aevitas’ proprietary rights to its short-form human complement factor H (“sCFH”) asset for the treatment of complement-mediated diseases. Under the terms of the 4DMT APA, 4DMT will make cash payments totaling up to$140 million if certain late-stage development, regulatory and sales milestones are met with respect to sCFH. A range of single-digit royalties on net sales are also payable. The aforementioned payments are payable solely to Aevitas, and 4DMT will be responsible for license payment obligations to the licensor of sCFH, University of Pennsylvania. 4DMT is not a related party to the Company and has assumed all ongoing and future development costs. The fair value of the interest in Aevitas retained by the Company of $2.6 million was based on the risk-adjusted present value of the aforementioned potential cash payments (see Note 6).
In connection with the 4DMT APA, the preferred shares of Aevitas held by the Company converted to Aevitas common shares, at which point the Company no longer maintained voting control of Aevitas. As a result, the Company deconsolidated its holdings in Aevitas. In connection with this transaction, the Company recorded a loss on deconsolidation of Aevitas of $3.4 million during the year ended December 31, 2023 in other expense in the Consolidated Statement of Operations.
Avenue
Agreements with InvaGen
In November 2018, Avenue entered into a Stock Purchase and Merger Agreement (the “Avenue SPMA”) with InvaGen Pharmaceuticals Inc. In November 2021, Avenue delivered InvaGen notice of termination of the Avenue SPMA and, in July 2022, Avenue entered into a Share Repurchase Agreement (the “Avenue SRA”) with InvaGen which closed in October 2022. In connection with the closing of the Avenue SRA, Avenue repurchased all the common shares of Avenue held by InvaGen, and all of the rights retained by InvaGen pursuant to the Stockholders Agreement entered into by and among Avenue, InvaGen and Fortress on November 12, 2018, were terminated. Under the Avenue SRA, Avenue agreed to pay InvaGen seven and a half percent (7.5%) of the proceeds from future financings, up to $4 million. In connection with funds raised in 2024 and 2023 (see Note 13), Avenue made payments totaling $0.7 million and $0.5 million, respectively, to InvaGen.
4. Inventory
Inventory consisted of the following:
| | | | | | |
|---|---|---|---|---|---|
| · December 31, · · December 31, | |||||
| ($ in thousands) · 2024 · · 2023 | |||||
| Raw materials | $3,196 | | $4,640 | ||
| Work-in-process | 367 | | 884 | ||
| Finished goods | 11,381 | | 4,987 | ||
| Inventory reserve | | (513) | | | (305) |
| Total inventories | $14,431 | | $10,206 | ||
- Property and Equipment
Fortress’ property and equipment consisted of the following:
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · Useful Life · December 31, · · December 31, | |||||||||
| ($ in thousands) · · (Years) · · 2024 · · 2023 | |||||||||
| Computer equipment | | 3 | | $595 | | $595 | |||
| Furniture and fixtures | | 5 | | 1,017 | | 1,017 | |||
| Leasehold improvements | | 15 | | 13,175 | | 13,175 | |||
| Buildings | | | 40 | | | 581 | | | 581 |
| Construction in progress | | N/A | | — | | 29 | |||
| Total property and equipment | | | | | 15,368 | | 15,397 | ||
| Impairment - Leasehold Improvements | | | | | | (2,176) | | | — |
| Less: Accumulated depreciation | | | | | (9,932) | | (8,892) | ||
| Property and equipment, net | | | | | $3,260 | | $6,505 | ||
Fortress’ depreciation expense for the years ended December 31, 2024 and 2023 was $1.0 million and $2.2 million, respectively, and was recorded in research and development, and selling, general and administrative expense in the Consolidated Statements of Operations.
Impairment of Long-Lived Assets
During the year ended December 31, 2024, Mustang concluded it had a triggering event requiring assessment of impairment for certain leasehold improvements and the related right-of-use asset. Mustang assessed the carrying value of the asset group consisting of the leasehold improvements and right-of-use asset in accordance with ASC 360, given the significant changes to Mustang’s operations, operating cash and the repurchase of equipment. The assessment of the recoverability of the asset group concluded that there was impairment on the carrying value of the asset group of approximately $2.6 million, which was allocated on a pro rata basis using the relative carrying amounts of the assets. Approximately $2.2 million of the impairment loss was allocated to leasehold improvements, with the remaining $0.4 million allocated to the right-of-use asset. At December 31, 2024, Mustang assessed the remaining improvements, right-of-use asset, and property, plant and equipment held for sale for impairment and concluded that the property, plant and equipment held for sale were impaired, based primarily on offers received from third parties. As such, Mustang recorded an additional impairment charge of $1.0 million for the property, plant and equipment held for sale. See Note 8 for asset impairment of $3.1 million recognized in the year ended December 31, 2023.
- Fair Value Measurements
Fair Value of Aevitas
The Company valued its retained investment in Aevitas, which is accounted for as an equity method investment for which the Company elected the fair value option, and estimated the fair value to be $2.6 million based on a per share value of $0.328. The following inputs were utilized to derive the value: risk free rate of return of 3.7%, volatility of 80% and a discount for lack of marketability of 39.7%.
Common Stock Warrant Liabilities
The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in ASC 480,Distinguishing Liabilities from Equity and ASC 815-40,* Derivatives and Hedging - Contracts in Entity’s Own Equity*. For warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded at their initial fair value on the date of issuance, and each balance sheet date thereafter.
| | | | |
|---|---|---|---|
| · · Warrants | |||
| ($ in thousands) | liabilities | ||
| Balance at December 31, 2022 | | $13,869 | |
| Avenue common stock warrants | | | 2,235 |
| Urica placement agent warrants | | | 33 |
| Change in fair value of common stock warrants - Avenue | | | (4,258) |
| Change in fair value of common stock warrants - Checkpoint | | | (7,924) |
| Change in fair value of placement agent warrants - Urica | | | 52 |
| Exercise of common stock warrants - Checkpoint | | | (3,121) |
| Balance at December 31, 2023 | | | 886 |
| Change in fair value of common stock warrants - Avenue | | | (170) |
| Change in fair value of common stock warrants - Checkpoint | | | 73 |
| Change in fair value of placement agent warrants - Urica | | | (24) |
| Exercise of common stock warrants - Avenue | | | (400) |
| Exchange of common stock warrants - Urica | | | (151) |
| Balance at December 31, 2024 | | $214 | |
Checkpoint
On December 16, 2022, Checkpoint closed on an offering for the sale of shares of its common stock and pre-funded warrants (the “Checkpoint December 2022 Registered Direct Offering”). The common stock and the pre-funded warrants were sold together with December 2022 Common Stock Warrants. Checkpoint also issued the placement agent warrants to purchase up to 104,046 shares of common stock with an exercise price of $5.406 per share (the “December 2022 Placement Agent Warrants”). Checkpoint deemed the December 2022 Common Stock Warrants and December 2022 Placement Agent Warrants to be classified as liabilities on the balance sheet as they contain terms for redemption of the underlying security that are outside its control. The December 2022 Common Warrants and December 2022 Placement Agent Warrants were recorded at the time of closing at a fair value, determined by using the Black-Scholes Model.
In October 2023, Checkpoint entered into the October 2023 Inducement with a holder of certain of its existing warrants to exercise for cash an aggregate of 6,325,354 shares of Checkpoint’s common stock at a reduced exercise price of $1.76 per share. Included in the exercise were the entirety of the December 2022 Common Stock Warrants. Checkpoint revalued the December 2022 Common Stock Warrants on October 4, 2023, resulting in a fair value of $3.1 million. Checkpoint also revalued the December 2022 Common Stock Warrants and December 2022 Placement Agent Warrants at each reporting period in 2023, and the decrease in the fair value of the common stock warrant liability throughout the year resulted in an offsetting gain on common stock warrant liabilities in the Statements of Operations. Since the December 2022 Placement Agent Warrants issued in the December 2022 Registered Direct Offering were not included in the October 2023 Inducement and have not been exercised, they will continue to be revalued at each reporting period for as long as
they remain outstanding. Checkpoint revalued the warrants at December 31, 2024 and 2023, resulting in a fair value of approximately $0.2 million and $0.1 million, respectively.
| | | | |
|---|---|---|---|
| · · Checkpoint | |||
| · · Warrant | |||
| ($ in thousands) · · Liability | |||
| Common Stock Warrant liabilities at December 31, 2022 | | $11,170 | |
| Change in fair value of common stock warrant liabilities | | | (7,924) |
| Exercise of common stock warrants | | | (3,121) |
| Common Stock Warrant liabilities at December 31, 2023 | | | 125 |
| Change in fair value of common stock warrant liabilities | | | 73 |
| Common Stock Warrant liabilities at December 31, 2024 | | $198 | |
A summary of the weighted average (in aggregate) significant unobservable inputs (Level 3 inputs) used in measuring the warrant liability that are categorized within Level 3 of the fair value hierarchy was as follows:
| | | | | | | | | |
|---|---|---|---|---|---|---|---|---|
| · · December 31, · · December 31, · · | ||||||||
| Checkpoint Warrants · · 2024 · · 2023 · · | ||||||||
| Exercise price | | $5.41 | | $5.41 | | | ||
| Volatility | | | 111.1% | | 96.4% | | ||
| Expected life in years | | | 3.0 | | | 4.0 | | |
| Risk-free rate | | | 4.3% | | 3.8% | | ||
Avenue
Avenue issued freestanding warrants to purchase shares of its common stock in connection with financing activities in October 2022 (the “October 2022 Warrants”) and January 2023 (the “January 2023 Warrants”, collectively the “Avenue Warrants”). The Avenue Warrants are classified as liabilities on the balance sheet as they contain terms for redemption of the underlying security that are outside of its control. In connection with the Avenue January 2023 Registered Direct Offering (see Note 13) in January 2023, the down-round price protection feature was triggered and the exercise price for the October 2022 Warrants was permanently adjusted to $116.25, which was the offering price for the Avenue Registered Offering in January 2023. The Black-Scholes model was used to value the October 2022 Warrants and January 2023 Warrants as of December 31, 2024 and 2023.
For the years ended December 31, 2024 and 2023, the decrease in the fair value of the Avenue Warrants resulted in a decrease in common stock warrant liabilities of $0.2 million and $4.3 million, respectively, with an offsetting gain recorded in the Statements of Operations.
| | | | |
|---|---|---|---|
| · · Avenue | |||
| · · Warrant | |||
| ($ in thousands) · · Liability | |||
| Avenue common stock warrant liabilities at December 31, 2022 | | $2,609 | |
| Issuance of common warrants | | | 2,235 |
| Change in fair value of common stock warrant liabilities | | | (4,258) |
| Avenue common stock warrant liabilities at December 31, 2023 | | | 586 |
| Exercise of Avenue common warrants | | | (400) |
| Change in fair value of common stock warrant liabilities | | | (170) |
| Avenue common stock warrant liabilities at December 31, 2024 | | $16 | |
A summary of the weighted average (in aggregate) significant unobservable inputs (Level 3 inputs) used in measuring the Avenue warrant liability that are categorized within Level 3 of the fair value hierarchy was as follows:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| | | December 31, | | | December 31 | | |
| | | 2024 | | | 2023 | | |
| Stock price | | $ 2.00 | | | $ 12.00 | | |
| Risk-free interest rate | 4.27% | | 3.84 - 4.23% | | |||
| Expected dividend yield | — | | — | | |||
| Expected term in years | 2.8 | | 2.1 - 3.8 | | |||
| Expected volatility | 155% | | 148 - 175% | |
Urica
Urica’s outstanding contingently issuable placement agent warrants were exchanged at the time of the exchange of the Urica 8% Cumulative Convertible Class B Preferred Stock on June 27, 2024 (see Note 9) for 202,834 warrants to purchase Fortress common stock at an exercise price of $1.68. The Fortress common stock warrants have afive-year life, expiring on June 27, 2029. The Company determined the placement agent warrants met the criteria for equity classification. At December 31, 2024 and 2023, the value of Urica’s contingent payment warrant wasnil and $0.2 million, respectively, and was recorded on the consolidated balance sheet.
| · · · | |
|---|---|
| · · December 31, | |
| · · 2023 | |
| Risk-free interest rate | 3.93% |
| Expected dividend yield | — |
| Expected term in years | 0.5 |
| Expected volatility | 153.6% |
- License Agreements
In accordance with ASC 730-10-25-1,Research and Development, costs incurred in obtaining technology licenses are charged to research and development expense if the technology licensed has not reached commercial feasibility and has no alternative future use. The licenses purchased by the Company require substantial completion of research and development, regulatory and marketing approval efforts in order to reach commercial feasibility and have no alternate use. The purchase prices of the licenses acquired is classified as research and development-licenses acquired in the consolidated statements of operations and for the years ended December 31, 2024 and 2023, expense recognized was $0.3 million and $4.3 million, respectively.
Journey
Emrosi (also known as DFD-29)
In June 2021, Journey entered a license, collaboration, and assignment agreement (the “Emrosi Agreement”) to obtain global rights for the development and commercialization of Emrosi TM (Minocycline Hydrochloride Extended-Release Capsules, 40mg), for the treatment of rosacea with Dr. Reddy’s Laboratories, Ltd (“DRL”); provided, that DRL retained certain rights to the program in select markets including Brazil, Russia, India and China. Pursuant to the terms and conditions of the Emrosi Agreement, Journey paid $10.0 million. In addition, Journey paid two developmental milestones in 2024. In April 2024 Journey paid a $3.0 milestone to DRL, based on FDA acceptance of the NDA application for Emrosi, and in December of 2024 Journey paid a $15.0 million milestone payment to DRL, which was triggered by the FDA marketing approval of Emrosi. Upon the $15.0 million milestone payment, the assets that had been the subject of the exclusive license related to Emrosi, including the NDA itself, the patents and other intellectual property, were assigned to Journey (see Note 8). Pursuant to the Emrosi Agreement, Journey may be required to pay additional contingent regulatory, commercial, and corporate-based milestone payments, totaling up to $150.0 million. Journey is required to pay royalties ranging from approximatelyten percent tofourteen percent on net sales of Emrosi, subject to certain possible reductions.
Qbrexza
In March 2021, Journey executed an Asset Purchase Agreement (the “Qbrexza APA”) with Dermira, Inc., a subsidiary of Eli Lilly and Company (“Dermira”). Pursuant to the terms of the Qbrexza APA, Journey acquired the rights to Qbexza® (glycopyrronium), a prescription cloth towelette to treat primary axillary hyperhidrosis in patients nine years of age or older from Dermira, Inc., Journey paid the upfront fee of $12.5 million to Dermira. In addition, Journey is obligated to pay Dermira up to $144 million in the aggregate upon the achievement of certain sales milestones. The royalty structure for the agreement is tiered with royalties for the first two years ranging approximately 40% to 30%. Thereafter for a period of eight years royalties are approximately 12% to 19%. Royalty amounts are subject to certain reductions in the event there is loss of exclusivity.
On August 31, 2023, Journey entered into a license agreement (the “New License Agreement”) with Maruho, whereby Journey agreed to grant an exclusive license to Maruho to develop and commercialize Qbrexza® for the treatment of primary axillary hyperhidrosis, in South Korea, Taiwan, Hong Kong, Macau, Thailand, Indonesia, Malaysia, Philippines, Singapore, Vietnam, Brunei, Cambodia, Myanmar and Laos (the “Territory”). Under the terms of the New License Agreement, in exchange for the exclusive rights to Qbrexza in the Territory and the amendment to the royalty payments associated with the Japanese license, Maruho paid $19.0 million to Journey as a non-refundable upfront payment. Prior to the date of the New License Agreement, Journey and Maruho were party to an existing exclusive amended and restated license agreement (the “First A&R License Agreement”), under which Maruho acquired exclusive license rights to Qbrexza® in Japan. In connection with Journey’s entry into the New License Agreement, Journey and Maruho also entered into the Second Amended and Restated Exclusive License Agreement (the “Second A&R License Agreement”), which supersedes the First A&R License Agreement. The Second A&R License Agreement contains modifications that remove Maruho’s obligation to pay Journey royalties on its net sales of Rapifort® (the Japanese equivalent of Qbrexza®) in Japan for sales occurring after October 1, 2023 and removes Maruho’s obligation to pay$10 million to Journey in the event that Maruho achieves net sales of at least ¥4 billion (yen) of Rapifort® during a single fiscal year. All other remaining potential milestone payment obligations, which aggregate to$45 million, remain in full force and effect. Journey recognized $19.0 million as other revenue in the consolidated statements of operations during the year ended December 31, 2023.
Accutane
In July 2020, Journey entered into an exclusive license and supply agreement for Accutane (the “Accutane Agreement”) with DRL. Pursuant to the Accutane Agreement, Journey paid $5.0 million. Three additional milestone payments totaling $17.0 million are contingent upon the achievement of certain net sales milestones. Journey is required to pay royalties in an amount equal to a low-double digit percentage of net sales. The term of the Accutane Agreement isten years and renewable upon mutual agreement. Each party may terminate the Accutane Agreement for an uncured material breach by the other party or for certain bankruptcy or insolvency related events. Journey may also terminate the Accutane Agreement without cause upon 180 days written notice to DRL.
Vyne
In January 2022, Journey entered into an Asset Purchase Agreement (the “Vyne APA”) with Vyne Therapeutics, Inc. (“Vyne”) to acquire Vyne’s Molecule Stabilizing Technology TM franchise (the “Acquisition”) for an upfront payment of $20.0 million and an additional $5.0 million payment on the one-year anniversary of the closing of the Acquisition. The Vyne APA also provides for contingent net sales milestone payments: in the first calendar year in which annual sales reach each of $100 million, $200 million, $300 million, $400 million and $500 million, Journey will be required to make a one-time payment of $10 million, $20 million, $30 million, $40 million and $50 million, respectively, in that year only, per product, totaling up to $450 million. In addition, Journey will pay Vyne 10% of any upfront payment received by Journey from a licensee or sublicensee of the products in any territory outside of the United States, subject to exceptions for certain jurisdictions as detailed in the Vyne APA. There are no subsequent milestone payments or royalties beyond the aforementioned payments. The Acquisition included two FDA-approved products (Amzeeq® and Zilxi®), and a development-stage dermatology program (FCD105), along with the Molecule Stabilizing Technology proprietary platform.
Part of the Vyne APA was Journey’s assumption of a license agreement with Cutia Therapeutics (HK) Limited, a Hong Kong biopharmaceutical company with experience in developing pharmaceutical products in the greater China region (the “Cutia Agreement”). Pursuant to the Cutia Agreement, Cutia was granted an exclusive license to obtain regulatory approval of and commercialize Amzeeq (topical 4% minocycline foam) and Zilxi (topical 1.5% minocycline foam) in mainland China, Taiwan, Hong Kong and Macau. Journey has agreed to supply the finished Licensed Products to Cutia for clinical and commercial use at an agreed price. On November 11, 2024, Cutia received marketing approval for topical 4% minocycline foam from the National Medical Products Administration (the “NMPA”) of the People’s Republic of China (the “PRC”). The approval triggered a $1.0 million milestone payment to Journey. The $1.0 million milestone payment was recorded as a component of other revenue in the Company’s Consolidated Statements of Operations for the year ended December 31, 2024.
Ximino
In July 2019, Journey entered into an asset purchase agreement for Ximino® (the “Ximino APA”) with Sun Pharmaceutical Industries, Inc. (“Sun”). Pursuant to the Ximino APA, total consideration was $9.4 million, with an upfront payment of $2.4 million paid in 2019. Pursuant to the terms of the Ximino APA, the remaining $7.0 million was due on the second anniversary and for the next four anniversaries of the Ximino APA thereafter. No additional licensing or milestone payments were required. Journey commenced sales of this product in August 2019, and discontinued selling Ximino in September 2023. In August 2024, Journey executed a settlement agreement with Sun for amounts owed under the Ximino APA (see Note 9).
Avenue
On February 28, 2023, Avenue entered into a license agreement with AnnJi Pharmaceutical Co. Ltd. ("AnnJi"), whereby Avenue obtained an exclusive license (the "AnnJi License Agreement") from AnnJi to the intellectual property rights pertaining to the molecule known as JM17, which activates Nrf1 and Nrf2, enhances androgen receptor degradation and underlies AJ201, a clinical product candidate currently in a Phase 1b/2a clinical trial in the U.S. for the treatment of SBMA, also known as Kennedy's Disease. Under the AnnJi License Agreement, in exchange for exclusive rights to the intellectual property underlying the AJ201 product candidates, Avenue agreed to pay $3.0 million, which was paid in the year ended December 31, 2023.
The license provided under the AnnJi License Agreement is exclusive as to all oral forms of AJ201 for use in all indications (other than androgenetic alopecia and Alzheimer’s disease) in the United States, Canada, the European Union, the United Kingdom and Israel. The AnnJi License Agreement also contains customary representations and warranties and provisions related to confidentiality, diligence, indemnification and intellectual property protection. Avenue will initially be obligated to obtain both clinical and commercial supply of AJ201 exclusively through AnnJi. AnnJi retains the manufacturing rights for AJ201 and Avenue has the option to acquire those rights from AnnJi as described in the AnnJi License Agreement.
Pursuant to the terms of the AnnJi License Agreement, Avenue was also obligated to issue two tranches of shares of its common stock and make additional payments including: reimbursement of payments up to $10.8 million in connection with the product’s Phase 1b/2a clinical trial (which AnnJi is currently administering with Joint Steering Committee Oversight before assigning the IND to Avenue upon such trial’s conclusion, and which is reflective of market pricing for the services to be received), up to $14.5 million in connection with certain development milestones pertaining to the first indication in the U.S., up to $27.5 million in connection with certain drug development milestones pertaining to additional indications and development outside the U.S., up to $165 million upon the achievement of certain net sales milestones ranging from $75 million to $750 million in annual net sales, and royalty payments based on a percentage of net sales ranging from mid-single digits to the low-double digits, which are subject to potential diminution in certain circumstances.
In connection with the signing of the AnnJi License Agreement, Avenue issued 11,089 shares of its common stock to AnnJi (“First Tranche Shares”) and recognized expense of $0.9 million; and issued 3,688 shares of common stock (“Second Tranche Shares”) and recognized expense of $0.3 million paid on September 26, 2023 upon enrollment of the eighth patient in the ongoing Phase 1b/2a SBMA clinical trial. Avenue and AnnJi entered into a Subscription Agreement, dated as of February 28, 2023, that provided for the issuance of First Tranche Shares which were issued March 30, 2023. In the event that the common stock of Avenue ceases to be traded on a national securities exchange, AnnJi has the right to
sell the common stock of Avenue back to Avenue at a price of $2.10 per share, subject to the terms of the AnnJi License Agreement.
On March 3, 2025, Avenue received a “notice of intent to terminate” letter from AnnJi with respect to the AnnJi License Agreement; Avenue believes that the grounds for termination stated in the purported termination notice are without merit and intends to avail itself of the dispute resolution procedures set forth in the AnnJi License Agreement.
Urica
In May 2021, Urica entered into an exclusive license agreement with Fuji to develop dotinurad in North America, Europe, and the UK. Dotinurad is approved for the treatment of gout and hyperuricemia in Japan. Urica paid a $3.0 million milestone payment in December 2021 upon IND submission of dotinurad. In December 2022 Urica expanded its exclusive license agreement with Fuji for the development of dotinurad to include the Middle East and North Africa (“MENA”) and Turkey territories. The amendment to the exclusive license agreement included a one-time license amendment payment of $0.3 million. In July 2024, Urica sold the rights to dotinurad to Crystalys (see Note 3).
Partner Companies and Subsidiaries
The Company’s partner companies and subsidiaries have also entered into other various license agreements with research institutions and medical centers. These license agreements include upfront payments which were expensed and various development milestone payments due upon achievement of various milestones which in the aggregate are approximately$191.3 million, of which$65.0 million relates to Mustang agreements. The license agreements also have sales-based milestone payments that total approximately$268.4 million. The agreements also include royalty payments on any future sales.
- Intangible Assets
The Company’s finite-lived intangible assets consist of intangible assets acquired by Journey. The table below provides a summary of intangible assets as of December 31, 2024 and 2023, respectively:
| | | | | | | | | |
|---|---|---|---|---|---|---|---|---|
| · · Estimated Useful · · December 31, · · December 31, | ||||||||
| ($ in thousands) · Lives (Years) · 2024 · 2023 | ||||||||
| Intangible assets – product licenses | | 3 to 15 | | $52,925 | | $37,925 | ||
| Accumulated amortization | | (17,919) | | (14,495) | ||||
| Accumulated Impairment loss | | | | | (3,143) | | | (3,143) |
| Net intangible assets | | $31,863 | | $20,287 | ||||
The Company’s amortization expense for the years ended December 31, 2024 and 2023 was approximately $3.4 million and $3.8 million, respectively. Amortization expense is recorded as a component of cost of goods sold in the Company’s consolidated statements of operations.
In the fourth quarter of 2024, the FDA approved Journey’s Emrosi for the treatment of inflammatory lesions of rosacea in adults. The approval triggered a $15.0 million milestone payment to DRL, which Journey capitalized as an acquired intangible asset. During the year ended December 31, 2023, Journey experienced lower net product revenues and gross profit levels for its Ximino products. Based on these results, Journey revised the financial outlook and plans for its Ximino products. Journey assessed the revised forecast for Ximino and determined that this constituted a triggering event and the results of the analysis indicated the carrying amount was not expected to be recovered. Journey recorded an intangible asset impairment charge of $3.1 million during the year ended December 31, 2023. This non-cash charge was recorded to operating expenses on the Consolidated Statements of Operations.
The future amortization of these intangible assets is as follows:
| | | | |
|---|---|---|---|
| · · Total | |||
| ($ in thousands) | Amortization | ||
| December 31, 2025 | | $$ 4,257 | |
| December 31, 2026 | | 3,471 | |
| December 31, 2027 | | | 2,775 |
| December 31, 2028 | | | 2,595 |
| December 31, 2029 | | | 2,595 |
| Thereafter | | | 12,228 |
| Sub-total | | $27,921 | |
| Asset not yet placed in service | | | 3,942 |
| Total | | $31,863 | |
- Debt and Interest
Debt
Total debt consists of the following:
| | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|
| · December 31, · · December 31, · Interest rate at · | ||||||||||
| ($ in thousands) · · 2024 · · 2023 · · December 31, 2024 · · Maturity | ||||||||||
| 2024 Oaktree Note | | $35,350 | | $— | 12.2% | July - 2027 | ||||
| 2020 Oaktree Note | | | — | | | 50,000 | 11.0% | August - 2025 | ||
| SWK Term Loan | | | 25,000 | | | 15,000 | | 14.8% | December - 2027 | |
| Less: Discount on notes payable | | | (2,388) | | | (4,144) | | | | |
| Total notes payable | | $57,962 | | $60,856 | ||||||
As of December 31, 2024, the carrying value of the notes payable approximates their fair value as the interest rate is variable and approximates the market rate for loans with similar terms and risk characteristics.
2024 Oaktree Note
On July 25, 2024, Fortress entered into a $50.0 million senior secured credit agreement (the “New Oaktree Agreement”) with a maturity date of July 25, 2027 with Oaktree Fund Administration, LLC and the lenders from time-to-time party thereto (collectively, “Oaktree”). The Company borrowed $35.0 million under the New Oaktree Agreement on the Closing Date (the “2024 Oaktree Note”) and is eligible to draw up to an additional $15.0 million at the lenders’ discretion to support future business development activities. The 2024 Oaktree Note replaces the 2020 Oaktree Note (as defined below) in which the remaining $50.0 million balance was repaid in full.
Under the terms of the New Oaktree Agreement, the loans have a 30-month interest-only period with a maturity date of July 25, 2027, and bear interest at an annual rate equal to the 3-month Secured Overnight Financing Rate (SOFR) plus 7.625% (subject to a 2.50% SOFR floor and a 5.75% SOFR cap). At December 31, 2024, the interest rate applicable to the 2024 Oaktree Note was 12.23%. The Company is required to make quarterly interest-only payments until the maturity date, except fifty percent of the then-outstanding principal balance of the loans is due on March 31, 2027, with the remaining principal amount due on the maturity date.
The Company may voluntarily prepay, in whole or in part, the amounts due under the New Oaktree Agreement at any time subject to a prepayment fee. Subject to prior written notice by the Company, to repay any amounts due prior to the maturity date, the Company must pay the sum of (A) the aggregate principal amount of the Loans being prepaid, (B) any accrued but unpaid interest on the principal amount of the Loans being prepaid, (C) any applicable Yield Protection Premium (as defined in the New Oaktree Agreement) and (D) if applicable, other unpaid amounts then due and owing pursuant to the New Oaktree Agreement and the other loan documents (such aggregate amount, the “Prepayment Price”); provided that each partial prepayment of the principal amount of the Loans shall be in an aggregate amount of at least $5.0 million and
integral multiples of $1.0 million in excess thereof. The Company is required to make mandatory prepayments of the Loans with net cash proceeds from (i) certain casualty events, (ii) certain monetization events, including, among other things, certain asset sales and the sale(s) of priority review vouchers by certain subsidiaries of the Company, and the receipt by the Company of any dividend or other distributions in cash from any of its subsidiaries in excess of $5.0 million other than in connection with certain monetization events, (iii) debt issuances that are not permitted, and (iv) failure to comply with certain covenants. The lenders may elect to receive warrants to purchase common stock of the Company as an alternative to cash prepayments in some situations where a mandatory prepayment would otherwise be required. No mandatory prepayments were required for the year ended December 31, 2024.
The New Oaktree Agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of other indebtedness, and dividends and other distributions, subject to certain exceptions. In addition, the New Oaktree Agreement contains certain financial covenants, including, (i) a requirement that the Company maintain a minimum liquidity of $7.0 million, which may be reduced or increased as described in the New Oaktree Agreement (“the “Liquidity Requirement”), and (ii) that product net sales of Journey meet a consolidated minimum net sales amount of $50.0 million on a trailing 12-month basis, tested quarterly, which may be reduced or increased as described in the New Oaktree Agreement (the “Minimum Net Sales Test”), subject to certain exclusions. Due to the approval of Emrosi, the minimum net sales amount will increase by $7.5 million each quarter, beginning in the third quarter of 2025, provided that the minimum net sales amount will in no event exceed $80.0 million. Both the Minimum Net Sales Test and the Liquidity Requirement will be reduced to $0 while the outstanding principal balance is less than or equal to $10.0 million. The Liquidity Requirement decreases to $5.0 million while the outstanding principal balance is between $10.0 million and $25.0 million. Failure by the Company to comply with the financial covenants will result in an event of default, subject to certain cure rights of the Company with respect to the Minimum Net Sales Test.
The New Oaktree Agreement contains events of default that are customary for financings of this type, in certain circumstances subject to customary cure periods. In addition, the Company is also required to (i) raise capital, or receive in monetizations or distributions, by the end of each calendar year prior to the maturity date, in an aggregate amount equal to the greater of $20 million or 50% of an amount set forth in an annual budget delivered to the lenders and (ii) maintain a specified minimum equity stake in Journey. The capital raise and minimum stake covenants and financial covenants, including minimum liquidity and minimum net sales, will not apply if the outstanding principal balance of the loan is less than or equal to $10 million. Following an event of default and any cure period, if applicable, the Agent will have the right upon notice to accelerate all amounts outstanding under the New Oaktree Agreement, in addition to other remedies available to the lenders as secured creditors of the Company.
In connection with the New Oaktree Agreement, the Company granted a security interest in favor of the Agent, for the benefit of the lenders, in substantially all of the Company’s assets, subject to customary exceptions, as collateral securing the Company’s obligations under the New Oaktree Agreement.
Also in connection with the New Oaktree Agreement, the Company granted warrants to the lenders to purchase up to 506,390 shares of the Company’s common stock at a purchase price of $2.0735 per share (the “Warrants”), later reduced to $1.65 per share in connection with the financing consummated by the Company in September 2024 (see note 13). The Warrants contain customary anti-dilution adjustments to the exercise price, including for share splits, share dividends, rights offerings and pro rata distributions. The exercise price of the Warrants will also be adjusted if, while the Warrants are outstanding, the Company engages in any transaction involving the issuance or sale of shares of Common Stock or equivalent securities at an effective price per share less than the exercise price of the Warrant then in effect (such lower price, the “Base Share Price”). In such case, the exercise price of the Warrants will be reduced to equal the Base Share Price. In connection with the financing consummated by the Company in September 2024, the Warrants had their exercise price reduced to $1.65 per share. The Warrants are exercisable from July 25, 2024 and will expire on July 25, 2031 and may be net exercised for no cash payment at the holder’s election. The Company filed a registration statement to register the resale of the shares of Company common stock issuable upon exercise of the Warrants (see Note 13).
The Company was in compliance with all applicable covenants under the New Oaktree Agreement as of December 31, 2024.
2020 Oaktree Note
On July 25, 2024, the Company’s $50.0 million outstanding balance of the senior secured credit agreement with Oaktree (the “Prior Oaktree Agreement”) and the debt thereunder, the “2020 Oaktree Note”) was terminated upon receipt by Oaktree of a payoff amount of $51.4 million from the Company comprised of principal, interest and the applicable final payment amount. The payoff of the 2020 Oaktree Note was treated as a debt extinguishment, as the 2024 Oaktree Note originated from a fund group different from the Prior Oaktree Agreement. The Company recorded a loss on extinguishment of debt of approximately $3.6 million, representing unamortized debt issuance costs and inclusive of a $1.0 million prepayment fee; the loss on extinguishment was recorded to interest expense in the Consolidated Statement of Operations for the year ended December 31, 2024.
The Company had entered the Prior Oaktree Agreement in August 2020. The Prior Oaktree Agreement contained customary representations and warranties and customary affirmative and negative covenants as well as certain financial covenants, including, among other things, (i) maintenance of minimum liquidity and (ii) a minimum revenue test that required Journey’s annual revenue to be equal to or to exceed annual revenue projections set forth in the Prior Oaktree Agreement. Failure by the Company or Journey, as applicable, to comply with the Prior Oaktree Agreement covenants would result in an event of default, subject to certain cure rights of the Company.
The Company was required to make quarterly interest-only payments until the fifth anniversary of the closing date of the 2020 Oaktree Note, August 27, 2025, at which point the outstanding principal amount would have been due. The Company could have voluntarily prepaid the 2020 Oaktree Note at any time subject to a prepayment fee. The Company was required to make mandatory prepayments of the 2020 Oaktree Note under various circumstances as defined in the Prior Oaktree Agreement
SWK Term Loan
On December 27, 2023 (the “SWK Closing Date”), Journey entered into a Credit Agreement with SWK Funding LLC (“SWK”). The Credit Agreement provides for a term loan facility (the “Credit Facility”) in the original principal amount of up to $20.0 million. On the SWK Closing Date, Journey drew $15 million. On June 26, 2024, Journey drew the remaining $5.0 million under the Credit Facility. On July 9, 2024, Journey entered into the Amendment to the Credit Agreement with SWK. The Amendment increased the original principal amount of the Credit Facility from $20.0 million to $25.0 million. The $5.0 million of additional principal added in the Amendment was contractually required to be drawn upon FDA approval of Emrosi, subject to Journey receiving approval on or before June 30, 2025. Journey drew on the remaining $5.0 million relating to the FDA approval of Emrosi on November 25, 2024.
Loans under the Credit Facility (the “Term Loans”) mature on December 27, 2027. The Term Loans accrue interest at a rate per annum equal to the three-month term SOFR (subject to a SOFR floor of 5%) plus 7.75% and interest is payable quarterly and resets quarterly.
Beginning in February 2026, Journey is required to repay a portion of the outstanding principal of the Term Loans quarterly in an amount equal to 7.5% of the principal amount of funded Term Loans, with any remaining principal balance due on the maturity date. If the total revenue of Journey, measured on a trailing twelve-month basis, is greater than $70.0 million as of December 31, 2025, the principal repayment start date is extended from February 2026 to February 2027, at which point Journey is required to repay a portion of the outstanding principal of the Term Loans quarterly in an amount equal to 15% of the principal amount of funded Term Loans, with any remaining principal balance due on the maturity date.
Journey may at any time prepay the outstanding principal balance of the Term Loans in whole or in part. Prepayment of the Term Loans is subject to payment of a prepayment premium equal to (i)2% of the Term Loans prepaid plus the amount of interest that would have been due through the first anniversary of the SWK Closing Date if the Term Loans are prepaid prior to the first anniversary of the SWK Closing Date, (ii)1% of the Term Loans prepaid if the Term Loans are prepaid on or after the first anniversary of the SWK Closing Date but prior to the second anniversary of the SWK Closing Date, or (iii)0% if prepaid thereafter.
Upon repayment in full of the Term Loans, Journey will pay an exit fee equal to 5% of the original principal amount of the Term Loans. Additionally, Journey paid an origination fee of$0.2 million on the SWK Closing Date and incurred issuance costs of$0.2 million, both of which have been recorded as a debt discount. Journey is accreting the carrying value of the SWK Term Loan to the original principal balance plus the exit fee over the term of the loan using the effective interest method. The amortization of the discount is accounted for as interest expense in the Consolidated Statement of Operations. The effective interest rate on the SWK Term Loan as of December 31, 2024 was 14.8%.
The SWK Credit Facility also includes both revenue and liquidity covenants, restrictions as to payment of dividends, and is secured by substantially all assets of Journey. As of December 31, 2024, Journey was in compliance with the financial covenants under the SWK Credit Facility.
East West Bank Line of Credit and Long-Term Debt (“EWB Term Loan”)
Journey was previously party to a Loan and Security Agreement, dated March 31, 2021 (as amended, the “EWB Facility”), with East West Bank (“EWB”), under which EWB made a$20.0 million term loan and a$10 million revolving line of credit available to Journey. In January 2022 and August 2022, Journey borrowed$15 million and$5 million, respectively, against the term loan. During 2023, Journey voluntarily repaid the entire $20 million outstanding term loan principal balance under the EWB Facility. The repayment satisfied all of Journey’s outstanding debt obligations under the EWB Facility. Journey has no further obligations to EWB.
Mustang Runway Growth Finance Corp. Debt Facility (“Runway Note”)
On April 11, 2023, thelong-term debt facility with Runway Growth Finance Corp. (the “Mustang Term Loan” or the “Runway Note”), wasterminated upon receipt by Runway of a payoff amount of$30.4 million from Mustang comprising of principal, interest and the applicable final payment amount. A loss on extinguishment of$2.8 million was recorded to interest expense in the Consolidated Statement of Operations for the year ended December 31, 2023.
IDB Letters of Credit
The Company has letters of credit (“LOC”) with one of its commercial banks, IDB Bank (“IDB”), of approximately $1.6 million and $2.4 million as of December 31, 2024 and 2023, respectively, securing rent deposits for lease facilities and an undertaking posted by Cyprium relating to an injunctive proceeding. The Company’s LOC’s are secured by cash, which is included in restricted cash on the Company’s Consolidated Balance Sheet. Interest paid on the letters of credit is 2% per annum.
Urica8% Cumulative Convertible Class B Preferred Offering
In December 2022 and February 2023, Urica closed private offerings of its 8% Cumulative Convertible Class B Preferred Stock (the “Urica Preferred Stock”), at a price of $25.00 per share (“Subscription Price”) pursuant to which it sold a total of 135,494 shares of Preferred Stock for gross proceeds of $3.4 million, before deducting underwriting discounts and commissions and offering expenses of approximately $0.5 million (the “Urica Offering”). A non-cash contingent warrant value of $0.1 million was also recorded in debt discount (see Note 6).
The Urica Preferred Shares have no voting rights and have liquidation rights on parity with all equity securities issued by Urica, and junior to all equity securities issued by Urica with terms outlining senior rank and current and future indebtedness.
The Company evaluated the terms of the Urica Preferred Offering under ASC 480, Distinguishing Liabilities from Equity, and determined the instrument met the criteria to be recorded as a liability. The value at conversion does not vary with the value of Urica’s common shares, therefore the settlement provision would not be considered a conversion feature. Accordingly, the Company determined liability classification is appropriate and as such, this instrument was accounted for as a liability.
Harley Capital LLC (“Harley”) was the primary placement agent for the Urica Offering and received a 10% cash fee on gross proceeds raised, plus either warrants to purchase 10% of the Urica common stock into which the Urica Preferred Stock converts (in the event of a sale of Urica or a qualified financing) or 10% of the Company common stock for which the Urica Preferred Stock is exchanged (in the event neither a sale of Urica nor a qualified financing occurs), in addition to reimbursement of legal and other expenses (see Note 6).
Dividends on the Urica Preferred Stock were payable monthly by Fortress in shares of Fortress Common Stock based upon a 7.5% discount to the average trading price over the 10-day period preceding the dividend payment date. Dividends were recorded as interest expense. For the years ended December 31, 2024 and 2023, the Company recorded expense of $0.1 million and $0.3 million, respectively, associated with the Urica dividends paid on the outstanding Urica Preferred Stock.
The shares mandatorily converted into Urica common stock upon either: (i) a qualified financing pursuant to which Urica raises at least $20 million in aggregate gross proceeds; or (ii) a sale of Urica. Additionally, in the event that neither such a qualified financing nor a sale of Urica had occurred prior to June 27, 2024, then each holder of Urica Preferred Stock was eligible to receive, at Fortress’ election, one of: (x) a cash payment equal to the product of the Subscription Price and the number of shares of Urica Preferred Stock held by such holder; (y) a number of shares of Fortress common stock equal to the Fortress Share Exchange Amount; or (z) a combination of the foregoing. On June 27, 2024, as neither a qualified financing nor a sale of Urica occurred, Fortress elected to exchange the outstanding shares of Urica Preferred Stock, which was recorded as a liability, into 2,028,345 shares of Fortress common stock.
Ximino Settlement
In August 2024, Journey executed a settlement agreement (the “Settlement Agreement”) to settle the $3.0 million of license installment payments Journey owed to Sun associated with the Ximino APA. Pursuant to the Settlement Agreement, Journey agreed to settle the total outstanding obligation owed to Sun for a total of $1.9 million, payable inthree installments: 1) $0.6 million upon execution of the Settlement Agreement, 2) $0.6 million on December 1, 2024, and 3) $0.6 million on January 15, 2025. Journey accounted for the settlement of the license installment payment as a $1.1 million gain on extinguishment of debt in the Condensed Consolidated Statements of Operations for the year ended December 31, 2024.
Interest Expense
The following table shows the details of interest expense for all debt arrangements during the periods presented. Interest expense includes contractual interest and amortization of the debt discount and amortization of fees represents fees associated with loan transaction costs, amortized over the life of the loan:
| | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Year Ended December 31, | ||||||||||||||||||
| · · 2024 · · 2023 | ||||||||||||||||||
| ($ in thousands) · Interest · Fees · Total · Interest · Fees · Total | ||||||||||||||||||
| 2024 Oaktree Note | | | 1,954 | | | 323 | | | 2,277 | | | — | | | — | | | — |
| 2020 Oaktree Note1 | | | 6,803 | | | 1,219 | | | 8,022 | | | 5,561 | | | 2,073 | | | 7,634 |
| Partner company convertible preferred shares | | | (290) | | | 90 | | | (200) | | | 1,023 | | | 503 | | | 1,526 |
| Partner company installment payments - licenses2 | | | — | | | — | | | — | | | 353 | | | — | | | 353 |
| Partner company notes payable3 | | | 2,385 | | | 307 | | | 2,692 | | | 4,856 | | | 492 | | | 5,348 |
| Partner company contingent call option accretion4 | | | 716 | | | — | | | 716 | | | — | | | — | | | — |
| Other | | 20 | | — | | 20 | | 122 | | 332 | | 454 | ||||||
| Total Interest Expense and Financing Fee | | $11,588 | | $1,939 | | $13,527 | | $11,915 | | $3,400 | | $15,315 | ||||||
| Note 1: | Includes loss on extinguishment of debt of $3.6 million related to the payoff of the 2020 Oaktree Note on July 25, 2024. |
|---|
| Note 2: | Imputed interest expense related to Ximino, Accutane, Anti-itch product license and VYNE product licenses (see Note 8) for the year ended December 31, 2023. |
|---|
| Note 3: | Includes loss on extinguishment of debt of $2.8 million recorded by Mustang related to payoff of the Runway Note on April 11, 2023. |
|---|
Note 4: Relates to Urica’s optional repurchase obligation to Crystalys (see Note 3).
10. Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses consisted of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, · · December 31, | ||||||
| ($ in thousands) · 2024 · 2023 | ||||||
| Accounts payable | | $31,636 | | $34,810 | ||
| Accrued expenses: | | | ||||
| Professional fees | | | 3,147 | | | 1,681 |
| Salaries, bonus and related benefits | | 6,596 | | 8,531 | ||
| Research and development | | 8,509 | | 11,644 | ||
| Accrued royalties payable | | 1,374 | | 2,015 | ||
| Accrued coupon and rebates | | 6,200 | | 9,987 | ||
| Return reserve | | | 3,124 | | | 4,077 |
| Other1 | | 4,915 | | 817 | ||
| Total accounts payable and accrued expenses | | $65,501 | | $73,562 | ||
| Note 1: | Other includes approximately $1.3 million of accrued consideration for the Mustang Repurchase Agreement with uBriGene, see Note 3. |
|---|
- Non-Controlling Interests
On April 21, 2023, Aevitas ceased to be a controlled Fortress entity and as such is no longer consolidated (see Note 3). Tamid was dissolved in the year ended December 31, 2023 due to inactivity.
The Company’s ownership interest in its consolidated subsidiaries in 2024 was similar to 2023, except for Avenue, which increased from 4% to 9.2% due to the acquisition of additional common shares (see Note 16); Journey, which decreased from 50% to 44.5% due to dilution from the issuance of equity securities (see Note 13) and Mustang, which decreased from 19% to 6.3% due to dilution from the issuance of equity securities (see Note 13).
- Net Loss per Common Share
Basic and diluted net loss per share attributed to common stockholders is calculated by dividing the net loss attributed to Fortress (less the Series A Preferred dividends) by the weighted-average number of shares of Common Stock outstanding during the period, not including unvested restricted stock, and without consideration for other potentially dilutive securities. Diluted net loss per share is the same as the basic loss per share due to net losses in all periods.
The Series A Preferred dividends included in the net loss per share calculation include dividends paid as well as dividends cumulated (but undeclared) (see Note 13). For the years ended December 31, 2024 and 2023, the effect on the net loss per share calculation from Series A Preferred dividends was $8.0 million and $8.0 million, respectively, and deemed dividends were $1.9 million and $0.7 million, respectively.
The following shares of potentially dilutive securities, weighted during the years ended December 31, 2024 and 2023 have been excluded from the computations of diluted weighted average shares outstanding as the effect of including such securities would be anti-dilutive:
| · · · · | ||
|---|---|---|
| | | |
| | | December 31, |
| · · 2024 · 2023 | ||
| Warrants to purchase Common Stock | 14,406,201 | 873,065 |
| Options to purchase Common Stock | 558,896 | 32,601 |
| Unvested Restricted Stock and deferred Restricted Stock | 1,900,630 | 1,514,208 |
| Unvested Restricted Stock units and deferred Restricted Stock units | 2,513,830 | 372,817 |
| Total | 19,379,557 | 2,792,691 |
- Stockholders’ Equity
Common Stock
Fortress’ Certificate of Incorporation, as amended, authorizes the Company to issue 200,000,000 shares of $0.001 par value Common Stock of which 27,908,839 and 15,093,053 shares of Common Stock were outstanding as of December 31, 2024 and 2023, respectively.
The terms, rights, preference and privileges of the Common Stock are as follows:
Voting Rights
Each holder of Common Stock is entitled to one vote per share of Common Stock held on all matters submitted to a vote of the stockholders, including the election of directors. The Company’s certificate of incorporation and bylaws do not provide for cumulative voting rights.
Subject to preferences that may be applicable to any then outstanding Preferred Stock, the holders of the Company’s outstanding shares of Common Stock are entitled to receive dividends, if any, as may be declared from time to time by the Company’s Board of Directors out of legally available funds.
Liquidation
In the event of the Company’s liquidation, dissolution or winding up, holders of Common Stock will be entitled to share ratably in the net assets legally available for distribution to stockholders after the payment of all of the Company’s debts and other liabilities, subject to the satisfaction of any liquidation preference granted to the holders of any outstanding shares of Preferred Stock.
Rights and Preference
Holders of the Company’s Common Stock have no preemptive, conversion or subscription rights, and there is no redemption or sinking fund provisions applicable to the Common Stock. The rights, preferences and privileges of the holders of Common Stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of the Company’s Preferred Stock that are or may be issued.
Series A Cumulative Redeemable Perpetual Preferred Stock
On October 26, 2017, the Company designated 5,000,000 shares of $0.001 par value preferred stock as Series A Cumulative Redeemable Perpetual Preferred Stock (the “Series A Preferred Stock”). As of December 31, 2024 and 2023,3,427,138 shares of Series A Preferred Stock were issued and outstanding.
The terms, rights, preference and privileges of the Series A Preferred Stock are as follows:
Voting Rights
Except as may be otherwise required by law, the voting rights of the holders of the Series A Preferred Stock are limited to the affirmative vote or consent of the holders of at least two-thirds of the votes entitled to be cast by the holders of the Series A Preferred Stock outstanding at the time in connection with the: (1) authorization or creation, or increase in the authorized or issued amount of, any class or series of capital stock ranking senior to the Series A Preferred Stock with respect to payment of dividends or the distribution of assets upon liquidation, dissolution or winding up or reclassification of any of the Company’s authorized capital stock into such shares, or creation, authorization or issuance of any obligation or security convertible into or evidencing the right to purchase any such shares; or (2) amendment, alteration, repeal or replacement of the Company’s certificate of incorporation, including by way of a merger, consolidation or otherwise in which the Company may or may not be the surviving entity, so as to materially and adversely affect and deprive holders of Series A Preferred Stock of any right, preference, privilege or voting power of the Series A Preferred Stock.
Dividends on Series A Preferred Stock accrue daily and will be cumulative from, and including, the date of original issue and shall be payable monthly at the rate of 9.375% per annum of its liquidation preference, which is equivalent to $2.34375 per annum per share. The first dividend on Series A Preferred Stock sold in the offering was payable on December 31, 2017 (in the amount of $0.299479 per share) to the holders of record of the Series A Preferred Stock at the close of business on December 15, 2017 and thereafter for each subsequent quarter in the amount of $0.5839375 per share.
On July 5, 2024, Fortress announced that the Company’s Board of Directors had decided to pause the monthly dividend of $0.1953125 per share of the Series A Preferred Stock. In accordance with the terms of the Series A Preferred Stock, dividends on the Series A Preferred Stock will continue to accrue and cumulate until such dividends are authorized or declared. The pausing of these dividends will defer approximately $0.7 million in cash dividend payments each month. The Board intends to revisit its decision regarding the monthly dividend regularly and will assess the profitability and cash flow of the Company to determine whether and when the pause should be lifted. The Company recorded approximately $4.0 million and $8.0 million of dividends in Additional Paid in Capital on the Consolidated Balance Sheets as of December 31, 2024 and 2023, respectively. At December 31, 2024, the Company had total undeclared dividends of approximately $4.0 million, which represents the cumulated (but undeclared) dividends due to Series A Preferred shareholders on December 31, 2024. Dividends in arrears that have not been declared by the Board of Directors are not recorded in the condensed consolidated balance sheets but are reflected in the net loss attributable to common shareholders (see Note 12).
No Maturity Date or Mandatory Redemption
The Series A Preferred Stock has no maturity date, and the Company is not required to redeem the Series A Preferred Stock. Accordingly, the Series A Preferred Stock will remain outstanding indefinitely unless the Company decides to redeem it pursuant to its optional redemption right or its special optional redemption right in connection with a Change of Control (as defined below), or under the circumstances set forth below under “Limited Conversion Rights Upon a Change of Control” and elect to convert such Series A Preferred Stock. The Company is not required to set aside funds to redeem the Series A Preferred Stock.
Optional Redemption
The Series A Preferred Stockmay be redeemed in whole or in part (at the Company’s option) any time on or after December 15, 2022, upon not less than 30 days nor more than 60 days’ written notice by mail prior to the date fixed for redemption thereof, for cash at a redemption price equal to $25.00 per share, plus any accumulated and unpaid dividends to, but not including, the redemption date. During the year ended December 31, 2024, no Series A Preferred Stock shares were redeemed.
Special Optional Redemption
Upon the occurrence a Change of Control (as defined below), the Company may redeem the shares of Series A Preferred Stock, at its option, in whole or in part, within one hundred twenty (120) days of any such Change of Control, for cash at $25.00 per share, plus accumulated and unpaid dividends (whether or not declared) to, but excluding, the redemption date. If, prior to the Change of Control conversion date, the Company has provided notice of its election to redeem some or all of the shares of Series A Preferred Stock (whether pursuant to the Company’s optional redemption right described above under “Optional Redemption” or this special optional redemption right), the holders of shares of Series A Preferred Stock will not have the Change of Control conversion right with respect to the shares of Series A Preferred Stock called for redemption. If the Company elects to redeem any shares of the Series A Preferred Stock as described in this paragraph, the Company may use any available cash to pay the redemption price.
A “Change of Control” is deemed to occur when, after the original issuance of the Series A Preferred Stock, the following have occurred and are continuing:
| ● | the acquisition by any person, including any syndicate or group deemed to be a “person” under Section 13(d)(3) of the Exchange Act of beneficial ownership, directly or indirectly, through a purchase, merger or other acquisition transaction or series of purchases, mergers or other acquisition transactions of the Company’s stock entitling that person to exercise more than 50% of the total voting power of all the Company’s stock entitled to vote generally in the election of the Company’s directors (except that such person will be deemed to have beneficial ownership of all securities that such person has the right to acquire, whether such right is currently exercisable or is exercisable only upon the occurrence of a subsequent condition); and |
| ● | following the closing of any transaction referred to in the bullet point above, neither the Company nor the acquiring or surviving entity has a class of common equity securities (or American Depositary Receipts representing such securities) listed on the NYSE, the NYSE American LLC or the Nasdaq Stock Market, or listed or quoted on an exchange or quotation system that is a successor to the NYSE, the NYSE American LLC or the Nasdaq Stock Market. |
Conversion, Exchange and Preemptive Rights
Except as described below under “Limited Conversion Rights upon a Change of Control,” the Series A Preferred Stock is not subject to preemptive rights or convertible into or exchangeable for any other securities or property at the option of the holder.
Limited Conversion Rights upon a Change of Control
Upon the occurrence of a Change of Control, each holder of shares of Series A Preferred Stock will have the right (unless, prior to the Change of Control Conversion Date, the Company has provided or provides irrevocable notice of its election to redeem the Series A Preferred Stock as described above under “Optional Redemption,” or “Special Optional Redemption”) to convert some or all of the shares of Series A Preferred Stock held by such holder on the Change of Control Conversion Date, into the Common Stock Conversion Consideration, which is equal to the lesser of:
| ● | the quotient obtained by dividing (i) the sum of the $25.00 liquidation preference per share of Series A Preferred Stock plus the amount of any accumulated and unpaid dividends (whether or not declared) to, but not including, the Change of Control Conversion Date (unless the Change of Control Conversion Date is after a record date for a Series A Preferred Stock dividend payment and prior to the corresponding Dividend Payment Date, in which case no additional amount for such accumulated and unpaid dividend will be included in this sum) by (ii) the Common Stock Price (such quotient, the “Conversion Rate”); and |
| ● | 13.05483 shares of common stock, subject to certain adjustments. |
In the case of a Change of Control pursuant to which the Company’s common stock will be converted into cash, securities or other property or assets, a holder of Series A Preferred Stock will receive upon conversion of such Series A Preferred Stock the kind and amount of Alternative Form Consideration which such holder would have owned or been entitled to receive upon the Change of Control had such holder held a number of shares of the Company’s common stock equal to the Common Stock Conversion Consideration immediately prior to the effective time of the Change of Control.
Notwithstanding the foregoing, the holders of shares of Series A Preferred Stock will not have the Change of Control Conversion Right if the acquiror has shares listed or quoted on the NYSE, the NYSE American LLC or Nasdaq Stock Market or listed or quoted on an exchange or quotation system that is a successor to the NYSE, the NYSE American LLC or Nasdaq Stock Market, and the Series A Preferred Stock becomes convertible into or exchangeable for such acquiror’s listed shares upon a subsequent Change of Control of the acquiror.
Liquidation Preference
In the event the Company liquidates, dissolves or is wound up, holders of the Series A Preferred Stock will have the right to receive $25.00 per share, plus any accumulated and unpaid dividends to, but not including, the date of payment, before any payment is made to the holders of the Company’s common stock.
Ranking
The Series A Preferred Stock will rank, with respect to rights to the payment of dividends and the distribution of assets upon the Company’s liquidation, dissolution or winding up, (1) senior to all classes or series of the Company’s common stock and to all other equity securities issued by the Company other than equity securities referred to in clauses (2) and (3); (2) on a par with all equity securities issued by the Company with terms specifically providing that those equity securities rank on a par with the Series A Preferred Stock with respect to rights to the payment of dividends and the distribution of assets upon the Company’s liquidation, dissolution or winding up; (3) junior to all equity securities issued by the Company with terms specifically providing that those equity securities rank senior to the Series A Preferred Stock with respect to rights to the payment of dividends and the distribution of assets upon the Company liquidation, dissolution or winding up; and (4) junior to all of the Company’s existing and future indebtedness.
Stock-Based Compensation
As of December 31, 2024, the Company had three equity compensation plans: the Fortress Biotech, Inc. 2013 Stock Incentive Plan, as amended, the Coronado Biosciences, Inc. 2012 Employee Stock Purchase Plan (the “ESPP”) (collectively, the “Plans”) and the Fortress Biotech, Inc. Long Term Incentive Plan (the “LTIP”). In the years ended December 31, 2024 and 2023, the Company’s Board of Directors and stockholders approved increases of 11.0 million and 0.5 million shares, respectively, to the Plans, bringing the aggregate total of authorized shares available under the Plans to 13.1 million shares. A total of 4.1 million shares have been granted under the Plans, net of cancellations, and 9.0 million shares remained available for issuance as of December 31, 2024.
Certain partner companies have their own equity compensation plan under which shares are granted to eligible employees, directors and consultants in the form of restricted stock, stock options, and other types of grants of stock of the respective partner company’s common stock. The table below provides a summary of those plans as of December 31, 2024:
| | | | | | | |
|---|---|---|---|---|---|---|
| Partner | | | | Shares | | Shares available at |
| Company · Stock Plan · Authorized · December 31, 2024 | ||||||
| Avenue | Avenue Therapeutics, Inc. 2015 Stock Plan | 5,070,223 | 4,575,701 | |||
| Cellvation | Cellvation Inc. 2016 Incentive Plan | 2,000,000 | 300,000 | |||
| Checkpoint | Checkpoint Therapeutics, Inc. Amended and Restated 2015 Incentive Plan | 18,000,000 | 8,010,406 | |||
| Cyprium | Cyprium Therapeutics, Inc. 2017 Stock Plan | 2,000,000 | 675,000 | |||
| Helocyte | DiaVax Biosciences, Inc. 2015 Incentive Plan | 2,000,000 | 341,667 | |||
| Journey | Journey Medical Corporation 2015 Stock Plan | 10,642,857 | 2,806,824 | |||
| Mustang | Mustang Bio, Inc. 2016 Incentive Plan | 14,666 | 6,946 | |||
| Oncogenuity | | FBIO Acquisition Corp. VII 2017 Incentive Plan | | 2,000,000 | | 1,200,000 |
| Urica | | FBIO Acquisition Corp. VIII 2017 Incentive Plan | | 4,000,000 | | 198,638 |
The purpose of the Company’s and its subsidiaries’ and partner companies’ equity compensation plans is to provide for equity awards as part of an overall compensation package of performance-based rewards to attract and retain qualified personnel. Such awards include, without limitation, options, stock appreciation rights, sales or bonuses of restricted stock, restricted stock units or dividend equivalent rights, and an award may consist of one such security or benefit, or two or more of them in any combination or alternative. Vesting of awards may be based upon the passage of time, the occurrence of one or more events, or the satisfaction of performance criteria or other conditions.
Incentive and non-statutory stock options are granted pursuant to option agreements adopted by the plan administrator. Options generally have 10-year contractual terms.
The Company and its subsidiaries and partner companies estimate the fair value of stock option grants using a Black-Scholes option pricing model. In applying this model, the following assumptions are used:
| ● | Risk-Free Interest Rate: The risk-free interest rate is based on the yields of United States Treasury securities with maturities similar to the expected term of the options for each option group. |
| ● | Volatility: The trading history of common stock is used to determine the expected stock price volatility. |
| ● | Expected Term: Due to the limited exercise history of the Company’s and its subsidiaries’ and partner companies’ stock options, the expected term was determined based on the Simplified Method under SAB 107 and the expected term for non-employees is the remaining contractual life for both options and warrants. |
| ● | Expected Dividend Rate: Neither the Company, nor its subsidiaries and partner companies, have paid and none anticipate paying any cash dividends in the near future on their common stock. |
The fair value of each option award was estimated on the grant date using the Black-Scholes option-pricing model and expensed under the straight-line method.
The following table summarizes the stock-based compensation expense from stock option, employee stock purchase programs, restricted stock and restricted stock unit awards for the years ended December 31, 2024 and 2023:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Year Ended December 31, | ||||||
| ($ in thousands) | | 2024 | 2023 | |||
| Fortress: | | | | | | |
| Employee and non-employee awards | | $9,026 | | $8,369 | ||
| Executive awards | | 1,047 | | 1,576 | ||
| | | | | | | |
| Partner Companies: | | | | | | |
| Avenue | | 1,236 | | 907 | ||
| Checkpoint | | 15,252 | | 2,897 | ||
| Mustang | | (450) | | 567 | ||
| Journey | | | 6,098 | | | 2,606 |
| Other | | 410 | | 107 | ||
| Total stock-based compensation expense | | $32,619 | | $17,029 | ||
For the years ended 2024 and 2023, $7.1 million and $3.2 million was included in research and development expenses, and $25.5 million and $13.8 million was included in selling, general and administrative expenses, respectively.
Options
The following table summarizes Fortress stock option activities, excluding activities related to partner companies:
| | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|
| | | | | | | | | | | Weighted average |
| · · · · · · · Total · · remaining | ||||||||||
| · · · · Weighted average · · weighted average · · contractual life | ||||||||||
| · Number of shares · exercise price · intrinsic value · (years) | ||||||||||
| Options vested and expected to vest at December 31, 2023 | 18,896 | | $20.55 | | $— | 1.76 | ||||
| Granted | | 540,000 | | | 1.68 | | | 186,300 | | 6.20 |
| Options vested and expected to vest at December 31, 2024 | 558,896 | | $2.32 | | $186,300 | 6.02 | ||||
| Options vested and exercisable at December 31, 2024 | | 18,896 | | $20.55 | | $— | 1.01 | |||
During the years ended December 31, 2024 and 2023, there wereno exercises of Fortress stock options.
The Company used the Black-Scholes option pricing model for determining the estimated fair value of stock-based compensation related to stock options. The table below summarizes the assumptions used:
| | | | | |
|---|---|---|---|---|
| | | Year Ended | | |
| · December 31, 2024 · | ||||
| Risk-free interest rate | | 4.3% | | |
| Expected dividend yield | | — | | |
| Expected term in years | | 7.0 | | |
| Expected volatility | | 90.1% | | |
As of December 31, 2024, Fortress had $0.4 million of unrecognized stock-based compensation expense related to Fortress stock options, which is expected to be recognized over a weighted-average period of 3.2 years.
As of December 31, 2024, on a consolidated basis, the Company had $1.0 million of unrecognized stock-based compensation expense related to stock options of Fortress and subsidiaries, which is expected to be recognized over a weighted-average period of 2.1 years.
Restricted Stock
Consolidated stock-based compensation expense from restricted stock awards and restricted stock units for the years ended December 31, 2024 and 2023 was $30.9 million and $16.0 million, respectively. Restricted stock awards and restricted stock unit awards are expensed under the straight-line method over the vesting period. Expense for awards with performance-based vesting criteria are measured and recorded if and when it becomes probable that the milestone will be achieved.
During 2024, the Company granted 0.5 million restricted shares of its Common Stock to executives and directors of the Company and 2.1 million restricted stock units to employees and non-employees of the Company. The fair value of the restricted stock awards issued during 2024 of $1.4 million and the fair value of the restricted stock unit awards issued during 2024 of $3.5 million were valued on the grant date using the Company’s stock price as of the grant date. The 2024 restricted stock awards and restricted stock unit awards vest upon both the passage of time as well as meeting certain performance criteria.
During 2023, the Company granted 0.2 million restricted shares of its Common Stock to executives and directors of the Company and 0.2 million restricted stock units to employees and non-employees of the Company. The fair value of the restricted stock awards issued during 2023 of $1.7 million and the fair value of the restricted stock unit awards issued during 2023 of $0.6 million were valued on the grant date using the Company’s stock price as of the grant date. The 2023 restricted stock awards and restricted stock unit awards vest upon both the passage of time as well as meeting certain performance criteria.
The following table summarizes Fortress’ restricted stock awards and restricted stock units activities, excluding activities related to Fortress subsidiaries:
| | | | | | |
|---|---|---|---|---|---|
| · · Weighted | |||||
| · · · · average grant | |||||
| · · Number of shares · · price | |||||
| Unvested balance at December 31, 2023 | | 2,066,810 | | $28.05 | |
| Restricted stock granted | | 468,357 | | | 3.01 |
| Restricted stock vested | | (17,303) | | | 34.65 |
| Restricted stock units granted | | 2,054,000 | | | 1.72 |
| Restricted stock units forfeited | | (19,485) | | | 14.56 |
| Restricted stock units vested | | (137,655) | | | 37.88 |
| Unvested balance at December 31, 2024 | | 4,414,724 | | $12.87 | |
The total fair value of restricted stock units and awards that vested during the years ended December 31, 2024 and 2023 was $5.8 million and $9.6 million, respectively. As of December 31, 2024, Fortress had unrecognized stock-based compensation expense related to all unvested Fortress restricted stock and Fortress restricted stock unit awards of $4.2 million and $4.8 million, respectively, which is expected to be recognized over the remaining weighted-average vesting period of 0.8 years and 3.4 years, respectively. As of December 31, 2024, on a consolidated basis, the Company had unrecognized stock-based compensation expense related to all unvested restricted stock and restricted stock unit awards of Fortress and subsidiaries of $9.5 million and $10.4 million, respectively, which is expected to be recognized over the remaining weighted-average vesting period of 1.3 years and 2.5 years, respectively. These amounts does not include restricted stock units which are performance-based and vest upon achievement of certain corporate milestones. Stock-based compensation for these awards will be measured and recorded if and when it is probable that the milestone will be achieved.
Deferred Compensation Plan
On March 12, 2015, the Company’s Compensation Committee approved the Deferred Compensation Plan allowing all non-employee directors the opportunity to defer all or a portion of their fees or compensation, including restricted stock and restricted stock units. During the years ended December 31, 2024 and 2023, certain non-employee directors elected to defer an aggregate of approximately 25,000 and 27,000 restricted stock awards, respectively, under this plan.
Employee Stock Purchase Plan
Eligible employees can purchase the Company’s Common Stock at the end of a predetermined offering period at 85% of the lower of the fair market value at the beginning or end of the offering period. The ESPP is compensatory and results in stock-based compensation expense.
As of December 31, 2024,0.1 million shares have been purchased and 1.0 million shares are available for future sale under the Company’s ESPP. The Company recognized share-based compensation expense of approximately $0.1 million and $0.1 million for the years ended December 31, 2024 and 2023, respectively.
Warrants
The following table summarizes Fortress warrant activities, excluding activities related to partner companies:
| | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|
| · · · · · · · Total weighted · · Weighted average | ||||||||||
| · · · · · · · average · · remaining | ||||||||||
| · · Number of · · Weighted average · · intrinsic · · contractual life | ||||||||||
| · shares · exercise price · value · (years) | ||||||||||
| Outstanding as of December 31, 2023 | 5,787,288 | | $1.88 | | $7,794,450 | 4.91 | ||||
| Issued | | 8,729,746 | | | 2.35 | | | 1,131,912 | | 4.83 |
| Exercised | | (107,500) | | | 1.67 | | | — | | — |
| Canceled | | (3,333) | | | 32.40 | | | — | | — |
| Outstanding as of December 31, 2024 | 14,406,201 | | $2.15 | | $2,933,774 | 4.46 | ||||
| Exercisable as of December 31, 2024 | 14,406,201 | | $2.15 | | $2,933,774 | 4.46 | ||||
In connection with the 2024 Oaktree Note (see Note 9), the Company issued warrants to Oaktree and certain of its affiliates to purchase up to approximately 0.5 million shares of Common Stock at a purchase price of $2.0735 per share (the “2024 Oaktree Warrants”). Oaktree is entitled to a reduction in exercise price if, at any time prior to the expiration of the 2024 Oaktree Warrants, the Company issues equity, warrants or convertible notes (collectively known as “Security Instruments”) at a price that is less than 95% of the market price of the Company’s Common Stock on the trading day prior to the issuance of the Security Instruments. As a result of the September 2024 registered direct offering (see Note 13), the exercise price on the 2024 Oaktree warrants was lowered to $1.65 per share, and approximately $20,000 was recorded to interest expense.
The Company evaluated the accounting treatment of the 2024 Oaktree Warrants and determined that the 2024 Oaktree warrants should be classified in stockholders’ equity. As such, the Company used a Black-Scholes model to value the Oaktree Warrants. Utilizing the following inputs: term of 7 years, volatility of 90.52%, risk-free rate of return of 4.18% yielding a value of $1.1 million and was recorded as a component of Stockholders’ Equity in the Company’s Condensed Consolidated Balance Sheet.
In connection with the 2020 Oaktree Note (see Note 9), in August 2020 the Company had issued warrants to Oaktree and certain of its affiliates to purchase up to approximately 0.1 million shares of Common Stock at an exercise price of $8.14 per share (the “Oaktree Warrants”). The Oaktree Warrants expire on August 27, 2030 and may be net exercised at the holder’s election. Oaktree is entitled to additional warrants if at any time prior to the expiration of the Oaktree Warrants the Company issues equity, warrants or convertible notes (collectively known as “Security Instruments”) at a price that is less than 95% of the market price of the Company’s Common Stock on the trading day prior to the issuance of the Security Instruments. As a result of the September 2024 registered direct offering (see Note 13), the Company issued an additional 14,450 warrants to Oaktree and adjusted the exercise price of the Oaktree Warrants to $7.2392, and recorded the resulting expense of $27,000 to interest expense.
The Company filed registration statement No. 333-282384 on Form S-1 to register the resale of the shares of Common Stock issuable upon exercise of the 2024 Oaktree Warrants and the additional Oaktree Warrants, which was declared effective by the SEC on October 7, 2024.
Amended and Restated Long-Term Incentive Program (“LTIP”)
On July 15, 2015, the stockholders approved the LTIP for the Company’s Chairman, President and Chief Executive Officer, Dr. Rosenwald, and Executive Vice Chairman, Strategic Development, Mr. Weiss. The LTIP consists of a program to grant equity interests in the Company and in the Company’s subsidiaries, and a performance-based bonus program that is designed to compensate LTIP participants based on their responsibilities and for their contributions to the successful achievement of certain corporate goals and objectives of the Company.
On January 1, 2024 and 2023, the Compensation Committee granted 216,465 and 81,286 shares each to Dr. Rosenwald and Mr. Weiss, respectively. These equity grants, made in accordance with the LTIP, represent 1% of total outstanding shares of the Company as of the dates of such grants. Restricted shares granted under the LTIP vest upon (i)(A) the Company achieving a specified increase in market capitalization since the grant date and (B) the participant remaining in service with the Company until (or being involuntarily terminated prior to) July 16, 2025, or (ii) a change in control of the Company, provided the eligible participant remains in service with the Company until the date of such transaction. If the restricted shares have not vested in accordance with the preceding sentence, they will be subject to a repurchase option by the Company at a nominal price for 90 days following the earlier of July 16, 2025 or the participant’s voluntary separation from service with the Company. The fair value of each grant on the grant date was approximately $0.7 million for the 2024 grant and $0.8 million for the 2023 grant. For the year ended December 31, 2024 and 2023, the Company recorded stock compensation expense related to LTIP grants of approximately $6.7 million and $5.8 million, respectively, on the Consolidated Statement of Operations.
Capital Raises
2024 Shelf
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”). 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, the board of directors paused the payment of dividends on our Series A Preferred Stock until further notices. As a result, the Company is no longer eligible to use Form S-3 and has lost the ability to use the 2024 Shelf.
Common Stock At the Market Offering
For the year ended December 31, 2024, the Company issued approximately 2.0 million shares of common stock at an average price of$1.98 per share for net proceeds of$3.8 million after deducting aggregate fees of$0.1 million. For the year ended December 31, 2023, the Company issued approximately 0.2 million shares of common stock at an average price of$9.61 per share for net proceeds of$2.2 million after deducting aggregate fees of$0.1 million.
Equity Offerings and Private Placements
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 commencingsix 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, the Company’s 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 commencingsix 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 connection with the financing consummated by the Company in September 2024, the 5,885,000 warrants issued in the November 2023 equity offering (the “November 2023 Warrants”) had their exercise price reduced to $1.65 per share. The November 2023 Warrants contained a one-time exercise price adjustment provision that reduced the exercise price upon the next equity financing at a price lower than the exercise price at issuance which was $1.70 per share.
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 2022 Shelf Registration Statement and At the Market Offering (the “Journey ATM”)
On December 30, 2022, Journey filed a shelf registration statement on Form S-3 (File No. 333-269079), which was declared effective by the SEC on January 26, 2023 (the Journey 2022 S-3”). The Journey 2022 S-3 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. In connection with the Journey 2022 S-3, Journey has entered into the Sales Agreement with B. Riley, relating to shares of the Journey’s common stock. In accordance with the terms of the Sales Agreement, Journey may offer and sell up to 4,900,000 shares of its common stock, par value $0.0001 per share, from time to time through or to B. Riley acting as Journey’s agent or principal.
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 under the Journey ATM 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 2023 Shelf Registration Statements
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.
Checkpoint Registered Direct Offerings
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 offive 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 rsale 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 fully 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. The offer and sale of the shares of common stock and the shares underlying the pre-funded warrants were registered for sale under the Checkpoint 2023 S-3. In March 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 January 2024 Common Stock Warrants and the placement agent warrants, which was declared effective April 5, 2024 (File No. 333-278397). All of the pre-funded warrants from the Checkpoint January 2024 Registered Direct Offering have been fully exercised.
Mustang 2021 Shelf Registration Statement and At-the-Market Offering
On April 23, 2021, Mustang filed a shelf registration statement on Form S-3 (File No. 333-255476) (the “Mustang 2021 S-3”), which was declared effective on May 24, 2021. Through the Mustang 2021 S-3, Mustang was able to sell up to a
total of $200 million of its securities. In 2024, Mustang sold approximately $4.4 million of securities under the Mustang 2021 S-3 until Mustang’s ability to register new offers and sales of securities under such registration statement expired on May 24, 2024.
On May 31, 2024, Mustang filed a shelf registration statement on Form S-3 (File No. 333-279891) (the “Mustang 2024 S-3”), which was declared effective on June 12, 2024. Under the Mustang 2024 S-3, Mustang may sell up to a total of $40.0 million of its securities. As of December 31, 2024, approximately $34.8 million of the Mustang 2024 S-3 remains available for sales of securities, subject to General Instruction I.B.6. of Form S-3. The ability of Mustang to register new offers and sales of securities under the Mustang 2024 S-3 expires on June 12, 2027.
On May 31, 2024, Mustang entered into an At-the-Market Offering Agreement (the “Mustang ATM”) relating to the sale of shares of common stock pursuant to the Mustang 2024 S-3. During the year ended December 31, 2024, Mustang issued approximately 0.1 million shares of common stock at an average price of $18.78 per share for net proceeds of $2.5 million under the Mustang ATM, after deducting aggregate fees of approximately $0.1 million.
During the year ended December 31, 2023, Mustang issued approximately 1,000 shares (adjusted for reverse split) of common stock at an average price of $158.07 per share for net proceeds of $0.2 million under the Mustang ATM.
Mustang Registered Direct and Equity Offerings, Warrant Inducement and Private Placement
In October 2024, Mustang entered into a definitive agreement for the exercise of certain existing warrants to purchase an aggregate of 337,552 shares of its common stock having an exercise price of $11.85 per share, originally issued in May 2024. The issuance or resale of the shares of common stock issuable upon exercise of the existing warrants are registered pursuant to an effective registration statement filed by Mustang on Form S-1 (File No. 333-278006). The net proceeds to Mustang from the exercise of the existing warrants were approximately $3.6 million, prior to deducting placement agent fees and offering expenses payable by Mustang of $0.4 million.
In consideration for the immediate exercise of the existing warrants for cash, Mustang issued two new series of unregistered warrants to purchase up to an aggregate of 675,104 shares of common stock. The new warrants have an exercise price of$13.50 per share and will be exercisable commencing on the effective date of stockholder approval of the issuance of the shares issuable upon exercise of the new warrants (the “Stockholder Approval”). One of the new series of warrants to purchase 337,552 shares of common stock has a term offive years from the Stockholder Approval, and the other new series of warrants to purchase 337,552 shares of common stock has a term oftwelve months from the Stockholder Approval.
In June 2024, Mustang closed on a registered direct offering of 60,500 shares of common stock at $20.50 per share (or common stock equivalent) priced at-the-market under Nasdaq rules and pre-funded warrants to purchase up to 62,100 shares of common stock, at a price per pre-funded warrant equal to $20.495, the price per share of common stock, less $0.005. The pre-funded warrants have an exercise price of $0.005 per share, became exercisable upon issuance and remain exercisable until exercised in full. In a concurrent private placement, Mustang also agreed to issue and sell unregistered warrants to purchase up to 62,100 shares of its common stock, with an exercise price of $20.495 per share, exercisable beginning on the effective date of stockholder approval of the issuance of the shares upon exercise of the warrants and will expire five years from the date of stockholder approval. Net proceeds were approximately $2.1 million, after placement agent’s fees and other offering expenses. All of the 62,100 pre-funded warrants have since been exercised.
In May 2024, Mustang closed on an equity offering of 23,200 shares of common stock and pre-funded warrants to purchase up to 314,352 shares of common stock (or common stock equivalents in lieu thereof), and three series of 337,552 warrants each for a total of 1,012,656 warrants with a combined equity offering price of $11.85 per share (or per share common stock equivalent in lieu thereof) and accompanying warrants with an exercise price of $11.85 per share. The Series A-1 warrants have afive-year term, the Series A-2 warrants have atwenty-four month term, and the Series A-3 warrants have anine month term. The warrants contain customary anti-dilution adjustments to the exercise price, including share splits, share dividends, rights offerings and pro rata distributions. The net proceeds of the equity offering, after deducting the fees and expenses of the placement agent and other offering expenses payable by Mustang was approximately $3.2 million. All of the 314,352 pre-funded warrants have since been exercised.
Pursuant to the terms of the Second Amended and Restated Founders Agreement, Mustang owes to Fortress 2.5% of the aggregate number of shares of Mustang common stock issued in the offerings noted above. Accordingly, Mustang issued 23,450 common shares to Fortress for the year ended December 31, 2024.
Avenue 2021 Shelf Registration Statement and At-the-Market Offering
In December 2021, Avenue filed a shelf registration statement (File No. 333-261520) on Form S-3 (the “Avenue 2021 S-3”), which was declared effective on December 10, 2021. As of December 31, 2024, approximately $2.2 million of the securities were available for sale under the Avenue 2021 S-3, subject to General Instruction I.B.6. of Form S-3.
In May 2024, Avenue entered into an At-the-Market Offering Agreement (the “Avenue ATM”) under which Avenue may offer and sell, from time to time at its sole discretion, up to $3.9 million of shares of its common stock. The offer and sale of the shares will be made pursuant to a base prospectus forming a part of the Avenue 2021 S-3, and the related prospectus supplement dated May 10, 2024. During the year ended December 31, 2024, Avenue issued 0.6 million shares through the Avenue ATM for net proceeds of $1.6 million.
Avenue 2024 Warrant Exercises and Private Placement
On January 5, 2024, Avenue entered into (i) an inducement offer letter agreement (the “January 2023 Investor Inducement Letter”) with a certain investor (the “January 2023 Investor”) in connection with certain outstanding warrants to purchase up to an aggregate of 25,871 shares of Common Stock, originally issued to the January 2023 Investor on January 31, 2023 (the “January 2023 Warrants”) and (ii) an inducement offer letter agreement (the “November 2023 Investor Inducement Letter Agreement” and, together with the January 2023 Investor Inducement Letter, the “January 2024 Warrant Inducement”) with certain investors (the “November 2023 Investors” and, together with the January 2023 Investor, the “Holders”) in connection with certain outstanding warrants to purchase up to an aggregate of 194,667 shares of Common Stock, originally issued to the November 2023 Investors on November 2, 2023 (the “November 2023 Warrants” and, together with the January 2023 Warrants, the “Existing Warrants”). The January 2023 Warrants had an exercise price of $116.25 per share, and the November 2023 Warrants had an exercise price of $22.545 per share.
Pursuant to the January 2024 Warrant Inducement, (i) the January 2023 Investor agreed to exercise its January 2023 Warrants for cash at a reduced exercise price of $22.545 per share and (ii) the November 2023 Investors agreed to exercise their November 2023 Warrants for cash at the existing exercise price of $22.545, in each case in consideration for Avenue’s agreement to issue in a private placement (x) Series A Warrants to purchase up to 220,538 shares of Avenue Common Stock and (y) Series B Warrants to purchase up to 220,538 shares of Avenue Common Stock. The net proceeds to Avenue from the exercise of the warrants was approximately $4.5 million, after deducting placement agent fees and estimated offering costs, but without giving effect to the exercise of the Series A Warrants and Series B Warrants issued in the January 2024 Warrant Inducement.
The fair value of the Series A Warrants and Series B Warrants was allocated between the January 2023 Warrants and the November 2023 Warrants on a weighted basis, with approximately $0.6 million allocated to the January 2023 Warrants and recorded to loss on common stock warrant liabilities in the condensed consolidated statement of operations, and the approximately $4.3 million allocated to the November 2023 Warrants deemed to be a dividend.
Also in April 2024, Avenue entered into definitive agreements for the immediate exercise of certain of its existing outstanding warrants to purchase an aggregate of 689,680 shares of Avenue’s common stock at a reduced exercise price of $6.20 per share (the “May 2024 Warrant Inducement”). The exercised warrants are comprised of warrants to purchase shares of common stock originally issued by Avenue on October 11, 2022, each having an exercise price of $116.25 per share, Series A and Series B warrants to purchase shares of common stock originally issued by Avenue on November 2, 2023, each having an exercise price of $22.545 per share, and warrants to purchase shares of common stock originally issued by Avenue on January 9, 2024, each having an exercise price of $22.545 per share. Total net proceeds to Avenue were approximately $3.7 million after deducting placement agent fees and other expenses payable by Avenue.
In consideration for the immediate exercise of the warrants for cash in the May 2024 Warrant Inducement, Avenue issued two new unregistered series of warrants (the “Avenue May 2024 Warrants”) to purchase up to a total of 1,379,360 shares
of Avenue common stock for a payment of $0.125 per warrant. The Avenue May 2024 Warrants have an exercise price of $6.20 per share, and terms ofeighteen months for one series andfive yearsfor the other series. The fair value of the Avenue May 2024 Warrants of approximately $4.5 million is deemed to be a dividend.
Pursuant to the Founders Agreement, Avenue issued to Fortress 2.5% of the aggregate number of shares of Avenue common stock issued in the offerings noted above. Accordingly, Avenue issued 43,772 shares to Fortress for the year ended December 31, 2024.
- Commitments and Contingencies
Leases
The Company’s lease portfolio includes leases for our corporate headquarters, office spaces, and a cell manufacturing facility. Most of the Company’s lease liabilities result from the lease of its New York City, NY office, which expires in 2031 and Mustang’s Worcester, MA cell processing facility lease, which expires in 2026 (see Note 20). Such leases do not require any contingent rental payments, impose any financial restrictions, or contain any residual value guarantees. Certain of the Company’s leases include renewal options and escalation clauses; renewal options have not been included in the calculation of the lease liabilities and right of use assets as the Company is not reasonably certain to exercise the options. The Company does not act as a lessor or have any leases classified as financing leases.
For the year ended December 31, 2024, Mustang identified triggering events that required an impairment of the asset group consisting of its right-of-use asset and associated leasehold improvements, and the impairment loss was allocated to leasehold improvements and the right-of-use assets based on the relative arrying amounts of the assets (see Note 5), with $0.4 million of the impairment allocated to the right-of-use asset group. At December 31, 2024, the Company had operating lease liabilities of $17.4 million and right of use assets of $13.9 million, which are included in the Company’s Consolidated Balance Sheet.
The Company recognizes rent expense on a straight-line basis over the non-cancellable lease term. Rent expense for the years ended December 31, 2024 and 2023 was $1.5 million and $1.9 million, respectively. The components of lease cost are as follows:
| · · · · · · · | ||||||
|---|---|---|---|---|---|---|
| | Year Ended December 31, | |||||
| ($ in thousands) · · 2024 · · 2023 · | ||||||
| Operating lease cost | | $2,758 | | $3,236 | | |
| Shared lease costs | | (2,100) | | | (2,086) | |
| Variable lease cost | | 865 | | | 761 | |
| Total lease expense | | $1,523 | | $1,911 | | |
The following tables summarize quantitative information about the Company’s operating leases:
| · · · · · · · · | ||||||
|---|---|---|---|---|---|---|
| | Year Ended December 31, | |||||
| ($ in thousands) · · 2024 · · 2023 · | ||||||
| Operating cash flows from operating leases | | $(3,647) | | $(3,549) | | |
| Right-of-use assets exchanged for new operating lease liabilities | | $188 | | $923 | | |
| Weighted-average remaining lease term – operating leases (years) | | 3.8 | | 4.2 | | |
| Weighted-average discount rate – operating leases | | 6.3% | 6.5% | | ||
| | | | |
|---|---|---|---|
| | Future Lease | ||
| ($ in thousands) · · Liability | |||
| Year Ended December 31, 2025 | | 3,533 | |
| Year Ended December 31, 2026 | | 3,272 | |
| Year Ended December 31, 2027 | | | 2,923 |
| Year Ended December 31, 2028 | | | 2,967 |
| Other | | 8,125 | |
| Total operating lease liabilities | | 20,820 | |
| Less: present value discount | | (3,447) | |
| Net operating lease liabilities, short-term and long-term | | $17,373 | |
License Agreements
The Company has undertaken to make contingent development and commercial milestone payments to the licensors of its portfolio of drug products and candidates. In addition, the Company shall pay royalties to such licensors based on a percentage of net sales of each drug candidate following regulatory marketing approval. For additional information on future milestone payments and royalties, (see Note 7).
Indemnification
In accordance with its certificate of incorporation, bylaws and indemnification agreements, the Company has indemnification obligations to its officers and directors for certain events or occurrences, subject to certain limits, while they are serving at the Company’s request in such capacity. There have been no claims to date, and the Company has director and officer insurance to address such claims. The Company and its subsidiaries and partner companies also provide indemnification of contractual counterparties (sometimes without monetary caps) to clinical sites, service providers and licensors.
Legal Proceedings
In the ordinary course of business, the Company and its subsidiaries may be subject to both insured and uninsured litigation. Suits and claims may be brought against the Company by customers, suppliers, partners and/or third parties (including tort claims for personal injury arising from clinical trials of the Company’s product candidates and property damage) alleging deficiencies in performance, breach of contract, etc., and seeking resulting alleged damages.
University of Tennessee Research Foundation v. Caelum Biosciences, Inc.
Caelum Biosciences, Inc. (“Caelum”), a former subsidiary of Fortress that was sold to AstraZeneca’s Alexion Pharmaceuticals, Inc. subsidiary (“Alexion”) in October 2021, was the defendant in a lawsuit brought by The University of Tennessee Research Foundation (“UTRF”) captioned asUniversity of Tennessee Research Foundation v. Caelum Biosciences, Inc., No. 19-cv-00508, which was formerly pending in the United States District Court for the Eastern District of Tennessee (the “UTRF Litigation”). UTRF brought claims against Caelum, for,inter alia, trade secret misappropriation. UTRF primarily alleged that Caelum unauthorizedly used non-patent trade secrets owned by UTRF in the development of Caelum’s 11-1F4 monoclonal antibody, known as CAEL-101. Under the agreement pursuant to which Alexion acquired Caelum (as amended, the “DOSPA”), Fortress had certain indemnification obligations of Caelum pertaining to the UTRF litigation and maintained a consent right over any potential settlements of the UTRF litigation by Caelum.
On September 16, 2024, Caelum and UTRF entered into a stipulation with the court pursuant to which UTRF’s claims were dismissed without prejudice; on October 16, 2024, Caelum and UTRF entered into a definitive settlement agreement (the “UTRF-Caelum Settlement Agreement”) pursuant to which UTRF’s claims were dismissed with prejudice and Caelum agreed to make an upfront payment and additional potential milestone-based payments to UTRF. Fortress and the other sellers under the DOSPA are explicit releasees and third party beneficiaries under the UTRF-Caelum Settlement Agreement. In connection with the execution of the UTRF-Caelum Settlement Agreement, Caelum, Alexion and Fortress
entered into an amendment to the DOSPA (the “DOSPA Amendment”), which,inter alia: (1) terminated any continuing indemnification by Fortress and the other sellers under the DOSPA in respect of the UTRF Litigation; (2) reduced the amounts of the potential future earn-out payments potentially owing to the sellers under the DOSPA (including Fortress) from an aggregate amount up to $350 million to an aggregate amount up to $295 million; (3) released to Caelum all amounts remaining in an escrow fund that had been established at the time of the Alexion acquisition to backstop potential indemnifiable damages, including those incurring under the UTRF Litigation (with 100% of such released amount constituting reimbursement for legal fees and other expenses incurred by Caelum in defending the UTRF Litigation); and (4) memorialized Fortress’ consent for Caelum to settle the UTRF Litigation. Neither the UTRF-Caelum Settlement Agreement nor the DOSPA Amendment implicates any out-of-pocket payment by Fortress or any other seller under the DOSPA. Fortress remains eligible to receive approximately $19 million upon regulatory approval of CAEL-101 and approximately $125 million in the aggregate across all remaining regulatory and sales milestones.
Journey Loss Recovery
In September 2021, Journey was the victim of a business email compromise cybersecurity incident, that affected its accounts payable function and led to approximately $9.5 million in wire transfers being misdirected to fraudulent accounts. Journey recorded the loss as a separate component of operating expenses in its 2021 consolidated financial statements. The FBI was able to trace and seize a portion of the fraudulently transferred cryptocurrency. Subsequently, pursuant to a stipulation and order signed by Journey on September 19, 2024, the United Stated District Court Southern District of New York through the United States Marshalls recovered funds of approximately $4.6 million on December 4, 2024. The proceeds from the recovery were recorded and classified within Journey’s Consolidated Statements of Operations as a separate component of operating expenses, consistent with the initial recognition of the loss in 2021.
- Employee Benefit Plan
On January 1, 2008, the Company adopted a defined contribution 401(k) plan which allows employees to contribute up to a percentage of their compensation, subject to IRS limitations and provides for a discretionary Company match up to a maximum of 4% of employee compensation. For the years ended December 31, 2024 and 2023, the Company paid a matching contribution of $0.8 million and $1.1 million, respectively.
- Related Party Transactions
Founders Agreement and Management Services Agreement
The Company has entered into Founders Agreements with each of the Fortress partner companies and subsidiaries listed in the table below. Pursuant to each Founders Agreement, in exchange for the time and capital expended in the formation of each partner company/subsidiary and the identification of specific assets the acquisition of which result in the formation of a viable emerging growth life science company, Fortress will loan each such partner company/subsidiary an amount representing the up-front fee required to acquire assets. Each Founders Agreement has a term of 15 years, which upon expiration automatically renews for successive one-year periods unless terminated by the Company or upon a Change in Control (as defined in the Founders Agreement) occurs. In connection with each Founders Agreement the Company received a number of either Class A Preferred shares or Class A Common Stock – see Note 20).
The Class A Preferred Stock or Class A Common Stock (such stock, the “Founders Stock”) is identical to common stock other than as to voting rights, conversion rights and the Payment-in-Kind (“PIK”) Dividend right (as described below). Each share of Founders Stock is entitled to vote the number of votes that is equal to one and one-tenth (1.1) times a fraction, the numerator of which is the sum of (A) the shares of outstanding common stock and (B) the whole shares of common stock into which the shares of outstanding Founders Stock are convertible and the denominator of which is the number of shares of outstanding Founders Stock. Thus, the Founders Stock will at all times constitute a voting majority. Each share of Founders Stock is convertible, at the holder’s option, into one fully paid and nonassessable share of common stock of such partner company/subsidiary, subject to certain adjustments.
The holders of Founders Stock, as a class, are entitled receive on each effective date or “Trigger Date” (defined as the date that the Company first acquired, whether by license or otherwise, ownership rights to a product) of each agreement (each
a “PIK Dividend Payment Date”) and on each anniversary date of such date until the date all outstanding Founders Stock is converted into common stock or redeemed (and the purchase price is paid in full), pro rata per share dividends paid in additional fully paid and nonassessable shares of common stock (“PIK Dividends”) such that the aggregate number of shares of common stock issued pursuant to such PIK Dividend is equal to two and one-half percent (2.5%) of such partner company or subsidiary’s fully-diluted outstanding capitalization on the date that is one (1) business day prior to any PIK Dividend Payment Date. The Company has reached agreements with several of the partner companies and subsidiaries to change the PIK Dividend Interest Payment Date to January 1 of each year - a change that has not and will not result in the issuance of any additional partner company/subsidiary common stock beyond that amount to which the Company would otherwise be entitled absent such change(s). The Company owns 100% of the Founders Stock of each partner company/subsidiary that has a Founders Agreement with the Company.
As additional consideration under the Founders Agreement, each partner company and subsidiary with which the Company has entered into a Founders Agreement will also: (i) pay an equity fee in shares of the common stock of such partner company/subsidiary, payable within five (5) business days of the closing of any equity or debt financing for each partner company/subsidiary or any of its respective subsidiaries that occurs after the effective date of the Founders Agreement and ending on the date when the Company no longer has majority voting control in such partner company or subsidiary’s voting equity, equal to two and one-half (2.5%) of the gross amount of any such equity or debt financing; and (ii) pay a cash fee equal to four and one-half percent (4.5%) of such partner company or subsidiary’s annual net sales, payable on an annual basis, within ninety (90) days of the end of each calendar year. In the event of a Change in Control, each such partner company/subsidiary will pay a one-time change in control fee equal to five (5x) times the product of (A) net sales for the twelve (12) months immediately preceding the change in control and (B) four and one-half percent (4.5%). In the case of Urica, however, the obligation to pay Fortress royalties under the Founders Agreement survives any such Change in Control.
The following table summarizes, by subsidiary, the PIK dividends, annual equity fees, and equity fees recorded by the Company in accordance with the terms of the Founders Agreements, Exchange Agreements and the partner companies’/subsidiaries’ certificates of incorporation for the years ended December 31, 2024 and 2023 ($ in thousands):
| | | | | | | | | |
|---|---|---|---|---|---|---|---|---|
| · · PIK Dividend · · Year Ended December 31, | ||||||||
| Partner company · Date · 2024 · 2023 | ||||||||
| Avenue | | January 1 | | | 410 | | | 444 |
| Cellvation | October 31 | | 10 | | 10 | |||
| Checkpoint | January 1 | | 8,633 | | 4,370 | |||
| Cyprium | January 1 | | 291 | | 304 | |||
| Helocyte | January 1 | | 39 | | 120 | |||
| Mustang | January 1 | | 940 | | 591 | |||
| Oncogenuity | May 8 | | 9 | | 9 | |||
| Urica | | November 25 | | | 514 | | | 502 |
| Fortress | | | | (10,846) | | (6,350) | ||
| Total | | | | $— | | $— | ||
Management Services Agreements
The Company has entered into Management Services Agreements (the “MSAs”) with certain of its partner companies and subsidiaries. Pursuant to each MSA, the Company’s management and personnel provide advisory, consulting and strategic services to each such partner company/subsidiary for an initial period of five (5) years (with such initial terms automatically renewing for successive five-year periods unless terminated by the Company or the partner company/subsidiary on at least 90 days’ notice prior to the expiration of any such five-year period). Such services may include, without limitation, (i) advice and assistance concerning any and all aspects of each such company’s operations, clinical trials, financial planning and strategic transactions and financings and (ii) conducting relations on behalf of each such company with accountants, attorneys, financial advisors and other professionals (collectively, the “Services”). Each such partner company/subsidiary is obligated to utilize clinical research services, medical education, communication and marketing services and investor relations/public relation services of companies or individuals designated by Fortress, provided those services are offered at market prices. However, such companies are not obligated to take or act upon any advice rendered from Fortress, and Fortress shall not be liable to any such partner company/subsidiary for its actions or inactions based upon Fortress’ advice. Fortress and its affiliates, including all members of Fortress’ Board of Directors, have been contractually exempted from fiduciary duties to each such partner company/subsidiary relating to corporate opportunities.
The following table summarizes, by partner company/subsidiary, the effective date of the MSA and the annual consulting fee payable by the partner company/subsidiary to Fortress in quarterly installments ($ in thousands):
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · · · · Year Ended December 31, · | |||||||||
| Partner Company/Subsidiary · Effective Date · 2024 · · 2023 | |||||||||
| Avenue1 | | February 17, 2015 | | 250 | | 500 | | ||
| Cellvation | | October 31, 2016 | | 500 | | 500 | | ||
| Checkpoint | | March 17, 2015 | | 500 | | 500 | | ||
| Cyprium | | March 13, 2017 | | 500 | | 500 | | ||
| Helocyte | | March 20, 2015 | | | 500 | | | 500 | |
| Mustang | | March 13, 2015 | | 500 | | 500 | | ||
| Oncogenuity | | February 10, 2017 | | | 500 | | | 500 | |
| Urica | | November 7, 2017 | | | 500 | | | 500 | |
| Fortress | | | | (3,750) | | (4,000) | | ||
| Consolidated (Income)/Expense | | | | $— | | $— | | ||
| Note 1: | Avenue’s MSA fee for 2024 was subject to a Subscription and Forgiveness Agreement signed in November 2024. |
|---|
Fees and Stock Issuances Received by Fortress
Fees recorded in connection with Fortress’ agreements with its subsidiaries and partner companies are eliminated in consolidation. These include management services fees, issuance of common shares of partner companies in connection with third party raises and annual stock dividend or issuances on the anniversary date of respective Founders Agreements.
Shared Services Agreement with TGTX
In July 2015, TGTX and the Company entered into an arrangement to share the cost of certain research and development employees. The Company’s Executive Vice Chairman, Strategic Development, is Executive Chairman and Interim Chief Executive Officer of TGTX. Under the terms of the Agreement, TGTX will reimburse the Company for the salary and benefit costs associated with these employees based upon actual hours worked on TGTX related projects. In connection with the shared services agreement, for the years ended December 31, 2024 and 2023, the Company invoiced TGTX $0.9 million and $0.4 million, respectively. At December 31, 2024, there was approximately $36,000 due from TGTX related to this arrangement.
Desk Share Agreement with TGTX
The Desk Share Agreement between the Company and TGTX, as amended, requires TGTX to pay 65% of the average annual rent for the Company’s New York, NY office space. Additionally, the Company has reserved the right to execute desk share agreements with other third parties and those arrangements will affect the cost of the lease actually borne by the Company. Each initial Desk Share Agreement has a term offive years. In connection with the Company’s Desk Share Agreement with TGTX for the New York, NY office space, for the years ended December 31, 2024 and 2023, the Company had paid $2.9 million and $2.8 million in rent, respectively, and invoiced TGTX approximately $1.7 million and $1.8 million respectively, for their prorated share of the rent base. At December 31, 2024, there wereno amounts due from TGTX related to this arrangement.
Avenue Subscription and Forgiveness Agreement
On November 13, 2024, the Company entered into a Subscription and Forgiveness Agreement with Avenue, whereby the Company agreed to convert 50% of a total of $0.5 million owed by Avenue under the MSA into newly issued common stock of Avenue and forgive the remaining 50% of the accrued balance. Therefore, Avenue issued a total of 122,850 shares to the Company based on the closing price of $2.035 on the day prior to the execution of the agreement.
Avenue September 2023 Private Placement
In September 2023, Avenue entered into an arrangement with Fortress and Dr. Lindsay A. Rosenwald (Dr. Rosenwald and Fortress, together, the “Avenue Private Placement Investors”), pursuant to which Avenue agreed to issue and sell 10,227 shares of Avenue common stock for an aggregate purchase price of approximately $550,000 in a private placement transaction. The Avenue common shares were purchased at a price per share of $53.775, by the Avenue Private Placement Investors, which was the “consolidated closing bid price” of the Avenue common stock on Nasdaq as of September 7, 2023, in compliance with Nasdaq Listing Rule 5365(c). The net proceeds to Avenue from the private placement were approximately $550,000.
Board Services Agreement
In December 2016, Checkpoint entered into an advisory agreement effective January 1, 2017 with Caribe BioAdvisors, LLC (“Caribe”), owned by Michael S. Weiss, to provide the advisory services of Mr. Weiss as Chairman of the Board. Pursuant to the agreement, Caribe will be paid an annual cash fee of $60,000, in addition to any and all annual equity incentive grants paid to members of the board. In June 2023, Mr. Weiss assigned the agreement with Checkpoint to Hawkins BioVentures, LLC, also owned by Michael Weiss. For the years ended December 31, 2024 and 2023, Checkpoint recognized approximately $153,000 and $110,000 in expenses related to the advisory agreement, including approximately $93,000 and $50,000 in expenses related to annual equity incentive grants.
In January 2017, Mustang entered into an advisory agreement effective January 1, 2017 with Caribe BioAdvisors, LLC, owned by Michael S. Weiss, to provide the advisory services of Mr. Weiss as Chairman of the Board. Pursuant to the agreement, Caribe will be paid an annual cash fee of $60,000, in addition to any and all annual equity incentive grants paid to members of the board. For the years ended December 31, 2024 and 2023, Mustang recognized approximately $60,000 and $110,000 in expenses related to the advisory agreement, respectively, including $50,000 in expenses related to annual equity incentive grants in 2023.
Checkpoint Collaborative Agreements with TGTX
Checkpoint previously entered into various agreements with TGTX to develop and commercialize certain assets in connection with its licenses, including a collaboration agreement for some of the Dana Farber licensed antibodies, and a sublicense agreement for the Jubilant family of patents. Effective September 30, 2023, Checkpoint and TGTX agreed to mutually terminate both the collaboration agreement and the sublicense agreement.
Shared Services Agreement with Journey
In November 2021, Journey and the Company entered into an arrangement to share the cost of certain legal, finance, regulatory, and research and development employees. The Company’s Executive Chairman and Chief Executive Officer is the Executive Chairman of Journey. Under the terms of the arrangement, Journey reimburses the Company for the salary and benefit costs associated with these employees based upon actual hours worked on Journey-related projects. In addition, Journey reimburses the Company for various payroll-related costs and selling, general and administrative costs incurred by Fortress for the benefit of Journey. For the year ended December 31, 2024 and 2023, the Company’s employees have provided services to Journey totaling approximately $38,000 and $0.1 million, respectively. At December 31, 2024, approximately $0.6 million is due from Journey, primarily related to reimbursable expenses incurred by Fortress on behalf of Journey.
Cyprium9.375% Series A Cumulative Redeemable Perpetual Preferred Stock Dividend Obligation
Pursuant to a private placement in August 2020, Cyprium sold shares of its 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock (“Cyprium PPS”); as of December 31, 2024, there are 320,000 shares of Cyprium PPS outstanding. The Cyprium PPS is fully and unconditionally guaranteed by Fortress.
Pursuant to the terms of the Cyprium PPS, shareholders on the record date are entitled to receive a monthly cash dividend of $0.19531 per share which yields an annual dividend of $2.34375 per share. The Cyprium PPS will automatically be redeemed upon the first (and only the first) bona fide, arm’s-length sale of a Priority Review Voucher (a “PRV Sale”) issued by the FDA in connection with the approval of CUTX-101, a product candidate previously developed by Cyprium. Upon the PRV Sale, each share of Cyprium PPS will be automatically redeemed in exchange for a payment equal to twice the $25.00 liquidation preference,plusaccumulated and unpaid dividends to, but excluding, the redemption date.
If a PRV Sale has not occurred by March 31, 2026 (the “Exchange Date), the Cyprium PPS will automatically be exchanged for Fortress Series A Preferred Stock or cash, at the discretion of Fortress.
- Income Taxes
Deferred income taxes reflect the net tax effects of (a) temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, and (b) operating losses and tax credit carryforwards.
The components of the income tax provision are as follows:
| · · · · · · | ||||
|---|---|---|---|---|
| · · Year Ended December 31, | ||||
| ($ in thousands) | 2024 | 2023 | ||
| Current | | | | |
| Federal | | $3 | | $33 |
| State | | 140 | | 254 |
| Deferred | | | | |
| Federal | | 136 | | 194 |
| State | | 33 | | 39 |
| Total | | $312 | | $521 |
For the years ended December 31, 2024 and 2023, income tax expense was $0.3 million and $0.5 million, respectively, resulting in an effective income tax rate of -0.2% and -0.3%. The income tax expense in 2024 is primarily due to uncovered deferred tax liabilities with respect to investments in subsidiaries, state income taxes and interest accrued related to a prior years' uncertain tax position.
The Company has incurred net operating losses since inception. The Company has not reflected any benefit of such net operating loss carryforwards (“NOL”) in the accompanying consolidated financial statements and has established a valuation allowance of $378.0 million against its net deferred tax assets. Deferred income taxes reflect the net tax effects of (a) temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, and (b) operating losses and tax credit carryforwards.
The significant components of the Company’s deferred taxes consist of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · As of December 31, | ||||||
| ($ in thousands) · · 2024 · · 2023 | ||||||
| Deferred tax assets: · · | ||||||
| Net operating loss carryforwards | | $232,740 | | $211,329 | ||
| Amortization of license fees | | 29,421 | | 33,996 | ||
| Amortization of in-process R&D | | 242 | | 315 | ||
| Stock compensation | | 12,773 | | 13,184 | ||
| Lease liability | | 4,763 | | 6,477 | ||
| Accruals and reserves | | 3,676 | | 3,897 | ||
| Tax credits | | 40,623 | | 37,894 | ||
| Startup costs | | 30 | | 40 | ||
| Unrealized gain/loss on investments | | 48 | | 55 | ||
| Section 174 R&D expenditure capitalization | | | 53,510 | | | 59,238 |
| State taxes | | | (70) | | | 33 |
| Business interest limitation | | | 4,154 | | | 2,880 |
| Reserve on Sales Return, Discount and Bad Debt | | 2,714 | | 4,556 | ||
| Total deferred tax assets | | 384,624 | | 373,895 | ||
| Less: valuation allowance | | (377,965) | | (366,375) | ||
| Net deferred tax assets | | $6,659 | | $7,520 | ||
| | | | | | | |
| Deferred tax liabilities: | | | ||||
| Section 483 imputed interest | | $— | | $(25) | ||
| Debt issuance costs | | | (42) | | | (297) |
| Right of use asset | | | (3,800) | | | (5,289) |
| Basis in subsidiary | | (3,219) | | (2,142) | ||
| Total deferred tax liabilities, net | | $(402) | | $(233) | ||
A reconciliation of the statutory tax rates and the effective tax rates is as follows:
| · · · · · | ||||
|---|---|---|---|---|
| · · For the Year Ended December 31, | ||||
| · 2024 · 2023 | ||||
| Percentage of pre-tax income: · · · | ||||
| U.S. federal statutory income tax rate | 21.0% | 21.0% | ||
| State taxes, net of federal benefit | 4.2% | 10.6% | ||
| Credits | 1.8% | 3.1 | | |
| Non-deductible items | (0.5)% | (0.9)% | ||
| Provision to return | (3.7)% | (0.7)% | ||
| Stock based compensation shortfall | (0.4)% | (2.0)% | ||
| Change in state rate | (8.2)% | 4.1% | ||
| Change in valuation allowance | (9.6)% | (31.5)% | ||
| Change in subsidiary basis | (1.0)% | (1.0)% | ||
| Deconsolidation/dissolution of subsidiaries | | —% | (2.4)% | |
| Adjustment for warrants | | (0.1)% | 0.9% | |
| Section 162(m) compensation disallowance | | (3.5)% | (1.2)% | |
| Other | (0.2)% | (0.3)% | ||
| Effective income tax rate | (0.2)% | (0.3)% | ||
The Company files a consolidated income tax return with subsidiaries for which the Company has an 80% or greater ownership interest. Subsidiaries and partner companies for which the Company does not have an 80% or more ownership are not included in the Company’s consolidated income tax group and file their own separate income tax return. As a result, certain corporate entities included in these financial statements are not able to combine or offset their taxable income or losses with other entities’ tax attributes.
ASC 740 requires a valuation allowance to reduce the deferred tax assets reported if, based on the weight of all positive and negative evidence, it is more likely than not that some portion, or all, of the deferred tax assets will not be realized. Realization of the deferred tax assets is substantially dependent on the Company’s ability to generate sufficient taxable income within certain future periods. Management has considered the Company’s history of cumulative tax and book losses incurred since inception, and the other positive and negative evidence, and has concluded that it is more likely than not that the Company will not realize the benefits of the net deferred tax assets as of December 31, 2024 and 2023. Accordingly, a full valuation allowance has been established against the net deferred tax assets as of December 31, 2024 and 2023. The valuation allowance increased by a net $11.6 million during the current year.
The Company has incurred net operating losses (“NOLs”) since inception. At December 31, 2024, the Company had federal NOLs of $802.4 million, which will begin to expire in the year 2032, state NOLs of $1,027.7 million, which will begin to expire in 2026, and federal income tax credits of $36.6 million and state income tax credits of $5.1 million, which will begin to expire in 2028. Approximately $606.9 million of the federal NOLs and $17.3 million of the state NOLs can be carried forward indefinitely. Under the provisions of Section 382 of the Internal Revenue Code, a corporation that undergoes an “ownership change”, as defined therein, is subject to limitations on its use of pre-change NOLs and income tax credits carryforwards to offset future tax liabilities. It appears the Company underwent previous ownership changes potentially limiting its use of tax attributes. The Company has recorded a full valuation allowance on all of its deferred tax assets, as it believes that it is more likely than not that the deferred tax assets will not be realized regardless of whether an “ownership change” has occurred.
In accordance with the provisions related to accounting for uncertainty in income taxes, the Company recognizes the benefit of tax position if the position is “more likely than not” to prevail upon examination by the relevant tax authority. The table below sets forth a reconciliation of the beginning and ending amount of unrecognized tax benefits:
For the year ended December 31, 2024, the company has $3.2 million of unrecognized tax benefits. If the $3.2 million of unrecognized tax benefits is recognized, approximately $0.7 million would affect the effective tax rate. It is reasonably possible that the amount of the unrecognized benefit with respect to certain of the Company’s recognized tax positions
will significantly increase or decrease within the next 12 months. At this time, the estimate of the range of the reasonably possible outcomes cannot be made.
The Company classifies interest and penalties related to uncertain tax positions as income tax expense. The Company has accrued for $0.2 million and approximately $0.1 million of such interest as of December 31, 2024 and 2023, respectively. No penalties have been accrued for. The NOLs from tax years 2010 through 2023 remain open to examination (and adjustment) by the Internal Revenue Service and state taxing authorities. In addition, federal tax years ending December 31, 2021, 2022 and 2023 are open for assessment of federal taxes. The expiration of the statute of limitations related to the various state income and franchise tax returns varies by state.
- Segment Information
The Company’s reportable segments for operating income (loss) for the years ending December 31, 2024 and 2023 consist of the following:
| | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Year Ended December 31, 2024 · Journey · · Avenue · · Checkpoint · · Mustang · · Fortress1 · · Consolidated | ||||||||||||||||||
| Product revenue, net | | $55,134 | | $— | | $— | | $— | | $— | | $55,134 | ||||||
| Collaboration revenue | | | — | | | — | | | — | | | — | | | 1,500 | | | 1,500 |
| Revenue - related party | | | — | | | — | | | 41 | | | — | | | — | | | 41 |
| Other revenue | | | 1,000 | | | — | | | — | | | — | | | — | | | 1,000 |
| Net revenue | | | 56,134 | | | — | | | 41 | | | — | | | 1,500 | | | 57,675 |
| | | | | | | | | | | | | | | | | | | |
| Cost of goods - (excluding amortization of acquired intangible assets) | | 20,879 | | | — | | | — | | | — | | | — | | 20,879 | ||
| Amortization of acquired intangible assets | | 3,424 | | | — | | | — | | | — | | | — | | 3,424 | ||
| Research and development | | | 9,857 | | | 6,645 | | | 36,152 | | | 8,418 | | | (4,443) | | | 56,629 |
| Research and development - licenses acquired | | | — | | | — | | | — | | | — | | | 252 | | | 252 |
| Selling, general and administrative | | | 40,204 | | | 4,638 | | | 20,063 | | | 4,135 | | | 18,691 | | | 87,731 |
| Loss recovery | | | (4,553) | | | — | | | — | | | — | | | — | | | (4,553) |
| Asset impairment | | | — | | | — | | | — | | | 3,692 | | | — | | | 3,692 |
| Total operating expenses | | | 69,811 | | | 11,283 | | | 56,215 | | | 16,245 | | | 14,500 | | | 168,054 |
| Loss from operations | | | (13,677) | | | (11,283) | | | (56,174) | | | (16,245) | | | (13,000) | | | (110,379) |
| | | | | | | | | | | | | | | | | | | |
| Interest Income | | | 757 | | | 176 | | | 11 | | | 184 | | | 1,555 | | | 2,683 |
| Interest expense and financing fee | | | (2,700) | | | — | | | — | | | (5) | | | (10,822) | | | (13,527) |
| (Gain) loss on common stock warrant liabilities | | | 1,125 | | | (589) | | | (73) | | | — | | | (1,101) | | | (638) |
| Other income (expense) | | | (116) | | | — | | | (4) | | | 314 | | | 1,124 | | | 1,318 |
| Total other income (expense) | | | (934) | | | (413) | | | (66) | | | 493 | | | (9,244) | | | (10,164) |
| Loss before income tax expense | | | (14,611) | | | (11,696) | | | (56,240) | | | (15,752) | | | (22,244) | | | (120,543) |
| | | | | | | | | | | | | | | | | | | |
| Income tax expense benefit | | | 61 | | | — | | | — | | | — | | | 251 | | | 312 |
| Segment net loss | | $(14,672) | | $(11,696) | | $(56,240) | | $(15,752) | | $(22,495) | | $(120,855) | ||||||
| | | | | | | | | | | | | | | | | | | |
| Net loss attributable to NCI | | | | | | | | | | | | | | | | | | 74,858 |
| | | | | | | | | | | | | | | | | | | |
| Net loss attributable to Fortress | | | | | | | | | | | | | | | | | $(45,997) | |
| | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | |
| Intersegment activity2: | | | | | | | | | | | | | | | | | | |
| Research and development | | $— | | $329 | | $7,638 | | $861 | | $(8,828) | | $— | ||||||
| Selling, general and administrative | | $— | | $331 | | $1,495 | | $579 | | $(2,405) | | $— | ||||||
| | | | | | | | | | | | | | | | | | | |
| Other Significant Items: | | | | | | | | | | | | | | | | | | |
| Depreciation expense | | $— | | $— | | $— | | $671 | | $369 | | $1,040 | ||||||
| Additions to intangible assets | | $15,000 | | $— | | $— | | $— | | $— | | $15,000 | ||||||
| Segment Assets | | $80,241 | | $2,672 | | $7,471 | | $9,308 | | $44,531 | | $144,223 | ||||||
| Stock-based compensation - research & development | | $508 | | $269 | | $5,248 | | $(650) | | $1,746 | | $7,121 | ||||||
| Stock-based compensation - Selling, general and administrative | | $5,590 | | $967 | | $10,004 | | $200 | | $8,737 | | $25,498 | ||||||
Note 1: Includes Fortress and private subsidiaries primarily funded by Fortress, including Cellvation, Cyprium, Helocyte, Oncogenuity and Urica; and intercompany eliminations.
| Note 2: | Intersegment activity consists of PIK Dividends and MSA and equity fees paid by the subsidiaries to Fortress, see Note 16. |
|---|
| | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Year Ended December 31, 2023 · Journey · · Avenue · · Checkpoint · · Mustang · · Fortress1 · · Consolidated | ||||||||||||||||||
| Product revenue, net | | $59,662 | | $— | | $— | | $— | | $— | | $59,662 | ||||||
| Collaboration revenue | | | — | | | — | | | — | | | — | | | 5,229 | | | 5,229 |
| Revenue - related party | | | — | | | — | | | 103 | | | — | | | — | | | 103 |
| Other revenue | | | 19,519 | | | — | | | — | | | — | | | — | | | 19,519 |
| Net revenue | | | 79,181 | | | — | | | 103 | | | — | | | 5,229 | | | 84,513 |
| | | | | | | | | | | | | | | | | | | |
| Cost of goods - (excluding amortization of acquired intangible assets) | | 22,893 | | | — | | | — | | | — | | | — | | 22,893 | ||
| Amortization of acquired intangible assets | | 3,767 | | | — | | | — | | | — | | | — | | 3,767 | ||
| Research and development | | | 7,541 | | | 6,131 | | | 43,566 | | | 40,513 | | | 3,996 | | | 101,747 |
| Research and development - licenses acquired | | | — | | | 4,230 | | | — | | | 527 | | | (433) | | | 4,324 |
| Selling, general and administrative | | | 43,910 | | | 4,179 | | | 8,685 | | | 8,220 | | | 25,987 | | | 90,981 |
| Asset impairment | | | 3,143 | | | — | | | — | | | — | | | — | | | 3,143 |
| Total operating expenses | | | 81,254 | | | 14,540 | | | 52,251 | | | 49,260 | | | 29,550 | | | 226,855 |
| Loss from operations | | | (2,073) | | | (14,540) | | | (52,148) | | | (49,260) | | | (24,321) | | | (142,342) |
| | | | | | | | | | | | | | | | | | | |
| Interest Income | | | 322 | | | 126 | | | 84 | | | 850 | | | 1,621 | | | 3,003 |
| Interest expense and financing fee | | | (1,698) | | | (332) | | | — | | | (4,109) | | | (9,176) | | | (15,315) |
| Gain (loss) on common stock warrant liabilities | | | — | | | 4,258 | | | 217 | | | — | | | (51) | | | 4,424 |
| Other (Income) expense | | | (183) | | | — | | | — | | | 917 | | | (4,137) | | | (3,403) |
| Total other (Income) expense | | | (1,559) | | | 4,052 | | | 301 | | | (2,342) | | | (11,743) | | | (11,291) |
| Loss before income tax expense | | | (3,632) | | | (10,488) | | | (51,847) | | | (51,602) | | | (36,064) | | | (153,633) |
| | | | | | | | | | | | | | | | | | | |
| Income tax (expense) benefit | | | 221 | | | — | | | — | | | — | | | 300 | | | 521 |
| Segment net loss | | $(3,853) | | $(10,488) | | $(51,847) | | $(51,602) | | $(36,364) | | $(154,154) | ||||||
| | | | | | | | | | | | | | | | | | | |
| Net loss attributable to NCI | | | | | | | | | | | | | | | | | | 93,517 |
| | | | | | | | | | | | | | | | | | | |
| Net loss attributable to Fortress | | | | | | | | | | | | | | | | | $(60,637) | |
| | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | |
| Intersegment Activity2: | | | | | | | | | | | | | | | | | | |
| Research and development | | $— | | $521 | | $3,419 | | $250 | | $(4,190) | | $— | ||||||
| Research and development - licenses acquired | | $— | | $— | | $— | | $477 | | $(477) | | $— | ||||||
| Selling, general and administrative | | $— | | $422 | | $1,452 | | $364 | | $(2,239) | | $— | ||||||
| | | | | | | | | | | | | | | | | | | |
| Other Significant Items: | | | | | | | | | | | | | | | | | | |
| Depreciation expense | | $— | | $— | | $— | | $1,860 | | $370 | | $2,230 | ||||||
| Segment assets | | $76,849 | | $1,850 | | $5,378 | | $17,742 | | $65,707 | | $167,526 | ||||||
| Stock-based compensation - research & development | | $110 | | $199 | | $1,169 | | $132 | | $1,624 | | $3,234 | ||||||
| Stock-based compensation - Selling, general and administrative | | $2,496 | | $707 | | $1,728 | | $436 | | $8,428 | | $13,795 | ||||||
Note 1: Includes Fortress and private subsidiaries primarily funded by Fortress: Aevitas (until April 2023), Cellvation, Cyprium, Helocyte, Oncogenuity and Urica; and intercompany eliminations.
| Note 2: | Intersegment activity consists of PIK Dividends and MSA and equity fees paid by the subsidiaries to Fortress, see Note 16. |
|---|
- Revenues from Contracts and Significant Customers
Disaggregation of Total Revenues
All of Journey’s product revenues are recorded in the U.S. During 2023, Journey received a one-time upfront license payment totaling $19.0 million from Maruho Ltd., its exclusive licensing partner in Japan (“Maruho”), under the license agreement Journey entered into with Maruho, dated August 31, 2023 (the “New License Agreement”) in which it granted Maruho exclusive rights to Qbrexza in Korea and other Asian countries. The Company’s collaboration revenue is from Cyprium’s agreement with Sentynl (see Note 3). The Company’s revenue - related party is from Checkpoint’s collaborations with TGTX (see Note 16).
The table below summarizes the Company’s revenue for the years ended December 31, 2024 and 2023:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Year Ended December 31, | ||||||
| ($ in thousands) · 2024 · 2023 | ||||||
| Qbrexza | | $25,114 | | $25,410 | ||
| Accutane | | | 19,407 | | | 20,168 |
| Amzeeq | | | 5,009 | | | 6,201 |
| Zilxi | | | 1,643 | | | 1,962 |
| Other / legacy product revenue | | | 3,961 | | | 5,921 |
| Collaboration revenue | | | 1,500 | | | 5,229 |
| Revenue – related party | | 41 | | 103 | ||
| Other revenue | | | 1,000 | | 19,519 | |
| Total net revenue | | $57,675 | | $84,513 | ||
Other revenue for the year ended December 31, 2024, reflects a $1.0 million milestone payment from Cutia triggered by the marketing approval Cutia received in the fourth quarter of 2024 for topical 4% minocycline foam in China (see Note 7). Other revenue for the year ended December 31, 2023, includes$0.5 million of royalties on sales of Rapifort in Japan from our licensing partner Maruho, from Maruho, and also reflects a net$19.0 million payment from Maruho under the New License Agreement (see Note 7).
Significant Customers
For the years ended December 31, 2024 and 2023, none of Journey’s Dermatology Products customers individually accounted for more than 10.0% of its total gross product revenue.
For the year ended December 31, 2024, one of Journey’s Dermatology Products customers accounted for more than 10% of its total accounts receivable balance at 10.3%. For the year ended December 31, 2023, one of Journey’s Dermatology Products customers accounted for more than 10% of its total accounts receivable balance at 13.0%.
- Subsequent Events
Checkpoint Merger Agreement
On March 9, 2025, Checkpoint entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Sun Pharmaceutical Industries, Inc., a Delaware corporation (“Sun Pharma” or “Parent”), and Snoopy Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Parent (“Merger Sub”). The Merger Agreement provides that, on the terms and subject to the conditions set forth in the Merger Agreement, Parent, Merger Sub and Checkpoint will effect
a merger of Merger Sub with and into Checkpoint (the “Merger”), with Checkpoint continuing as the surviving corporation of the Merger and a wholly owned subsidiary of Parent.
Pursuant to the Merger Agreement, at the effective time of the Merger (the “Effective Time”), each share of common stock and each share of Class A common stock of Checkpoint (collectively, the “Shares”) (including each unvested Checkpoint restricted share) outstanding immediately prior to the Effective Time will be canceled and cease to exist and be converted into the right to receive (i) $4.10 in cash, without interest (the “Common Cash Amount”), and (ii) one non-tradable contingent value right (a “CVR”), which will represent the right to receive a contingent cash payment of up to $0.70 upon the achievement of specified milestones, subject to and in accordance with the terms and conditions set forth in a Contingent Value Rights Agreement, substantially in the form attached as Exhibit B to the Merger Agreement (the “CVR Agreement”), as further described below (the foregoing clauses (i) and (ii), the “Merger Consideration”), in each case subject to applicable withholding taxes.
Consummation of the Merger is subject to customary closing conditions, including, but not limited to: (i) the adoption of the Merger Agreement and approval of the Merger by (a) the affirmative vote of the holders of at least a majority of the outstanding Shares beneficially owned by Checkpoint stockholders other than (1)Fortressand its controlled affiliates (other than Checkpoint), (2) the members of the Checkpoint board of directors (the “Checkpoint Board”) (and their controlled affiliates, if any) and (3) any person that Checkpointhas determined to be an “officer” of Checkpoint within the meaning of Rule 16a-1(f) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) (the “Unaffiliated Checkpoint Stockholders”), and (b) the affirmative vote of the holders of a majority in voting power of outstanding the Shares; (ii) expiration or early termination of any waiting periods applicable to the consummation of the Merger under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, without the imposition of any burdensome condition; (iii) absence of any law or order prohibiting or making illegal the consummation of the Merger; and (iv) no Checkpoint material adverse effect having occurred that is continuing. The consummation of the Merger is also conditioned upon each of the Support Agreement, the Transition Services Agreement, the Royalty Agreement, and the CVR Agreement (in each case, as defined below) being in full force and effect.
The Merger Agreement contains customary representations, warranties and covenants made by each of Parent, Checkpoint and Merger Sub, including, among others customary covenants regarding the operation of the business of Checkpoint prior to the Effective Time, and “no-shop” restrictions regarding certain alternative acquisition proposals or discussions with third parties.
The Merger Agreement includes customary termination rights for the parties, including that, subject to certain limitations, Checkpoint or Parent may terminate the Merger Agreement prior to the Effective Time if: (i) a governmental body issues or enacts a final and non-appealable order, injunction or other legal requirement prohibiting or making illegal the consummation of the Merger, (ii) if the Effective Time has not occurred on or prior to 11:59 p.m. Eastern Time on September 5, 2025 or (iii) the stockholders of Checkpoint fail to adopt the Merger Agreement by the requisite majorities at a meeting of Checkpoint’s stockholders at which a vote on the Merger is conducted.
Checkpoint may terminate the Merger Agreement in certain additional limited circumstances, including to allow Checkpoint to enter into an agreement providing for an alternative acquisition transaction that constitutes a Superior Proposal (as defined in the Merger Agreement). Parent may terminate the Merger Agreement in certain additional limited circumstances, including if the Checkpoint Board, or any committee thereof, including the Special Committee of the Checkpoint Board, withdraws, withholds, amends or qualifies or modifies, in each case, in a manner adverse to Parent or Merger Sub, its recommendation that the stockholders of Checkpoint vote to adopt the Merger Agreement and approve the Merger.
Upon termination of the Merger Agreement under certain specified circumstances, Checkpoint will be required to pay Parent a termination fee (the “Checkpoint Termination Fee”) of $12.5 million. Specifically, the Checkpoint Termination Fee is payable if (i) the Merger Agreement is terminated in certain circumstances; (ii) prior to such termination (but after the date of the Merger Agreement) a bona fide proposal for an alternative acquisition transaction has been publicly disclosed or otherwise made to the Checkpoint Board and not publicly withdrawn (if made publicly); and (iii) within one year of such termination, Checkpoint subsequently consummates an alternative acquisition transaction or enters into a definitive agreement providing for an alternative acquisition transaction and such transaction is ultimately consummated.
The Checkpoint Termination Fee will also be payable if the Merger Agreement is terminated: (a) by Parent, if Checkpoint Board, or any committee thereof, including the Special Committee of the Checkpoint Board, withdraws, withholds, amends or qualifies or modifies, in each case, in a manner adverse to Parent or Merger Sub, its recommendation that the stockholders of Checkpoint vote to adopt the Merger Agreement and approve the Merger; or (b) by Checkpoint in order to enter into an agreement providing for an alternative acquisition transaction that constitutes a Superior Proposal.
CVR Agreement
Pursuant to the Merger Agreement, as of or prior to the Effective Time, Parent and a rights agent (the “Rights Agent”) will enter into the CVR Agreement governing the terms of the CVRs issued in connection with the Merger. The Rights Agent will maintain an up-to-date register of the holders of CVRs (the “Holders”). Holders shall not be permitted to transfer the CVRs (subject to certain limited exceptions as set forth in the CVR Agreement).
Each CVR represents the right to receive one of the following contingent cash payments, without interest, subject to any applicable withholding taxes (such applicable payment, the “Milestone Payment”), conditioned upon the achievement of the corresponding milestone condition within the following specified time periods:
| (i) | $0.70, if the Milestone (as defined below) is first achieved on or prior to the date that is 12 months prior to Milestone Deadline Date (as defined below) and the applicable regulatory approval provides for a dosing schedule of once every three weeks, |
| (ii) | $0.45, if the Milestone is first achieved on or prior to the date that is 12 months prior to the Milestone Deadline Date and the applicable regulatory approval provides for a dosing schedule that is more frequent than once every three weeks, |
| (iii) | $0.45, if the Milestone is first achieved after the date that is 12 months prior to the Milestone Deadline Date but on or prior to the Milestone Deadline Date, and the applicable regulatory approval provides for a dosing schedule of once every three weeks, or |
| (iv) | $0.20, if the Milestone is first achieved after the date that is 12 months prior to the Milestone Deadline Date but on or prior to the Milestone Deadline Date, and the applicable regulatory approval provides for a dosing schedule that is more frequent than once every three weeks. |
As used in the CVR Agreement, (a) the “Milestone Deadline Date” means the date that is 36 months after the date on which a marketing authorization application or equivalent for cosibelimab receives a positive validation outcome by the European Medicines Agency (the “EMA”) and (b) the “Milestone” means the receipt of regulatory approval of (i) cosibelimab in the European Union pursuant to the centralized approval procedure or (ii) any of Germany, France, Italy, Spain or the United Kingdom.
Parent (directly or through its affiliates) is obligated to use, and to obligate its licensees to use, certain specified commercially reasonable efforts to (i) file a marketing authorization application for cosibelimab with the EMA within 12 months of the Closing Date or, to the extent any feedback or communications from, or expectations or requirements of, the EMA (including additional trial requirements) make it impracticable or inadvisable to file such marketing authorization application within such time period, as promptly thereafter as practicable, and (ii) achieve the Primary Milestone (as defined in the CVR Agreement) in its then-maximum value as promptly as practicable (including timely filing any appeals and curing any deficiencies identified in a relevant marketing authorization application by the relevant regulatory authority). Parent’s obligations to use such commercially reasonable efforts terminates on the earlier of (a) the Milestone Deadline Date and (b) the achievement of the Milestone. There can be no assurance that the Milestone will be achieved on or before the Milestone Deadline Date, or that any Milestone Payments will be made.
Support Agreement
Concurrently with the execution of the Merger Agreement, Checkpoint entered into a Support Agreement (the “Support Agreement”) with Parent and Fortress. Under the terms of the Support Agreement, Fortress has agreed to, among other
things, during the term of the Support Agreement, (i) vote its Shares in favor of the adoption of the Merger Agreement and the approval of the Merger and the other transactions contemplated by the Merger Agreement, and against any acquisition proposal or any action, proposal, agreement, transaction or arrangement that is intended, or would reasonably be expected, to result in a material breach of a covenant, representation or warranty or any obligation of Checkpoint under the Merger Agreement or any of the conditions to Checkpoint’s obligations under the Merger Agreement not being fulfilled or satisfied, (ii) not transfer its Shares (subject to certain exceptions), and (iii) waive and not to exercise any appraisal rights in respect of such Shares that may arise with respect to the Merger and not to commence or participate in, any class action or legal action (a) challenging the validity of, or seeking to enjoin or delay the operation of any provision of the Merger Agreement or (b) with respect to claims against the Checkpoint Board, or any committee thereof, Parent of Merger Sub relating to the Merger Agreement or the transactions contemplated thereby.
Under the Support Agreement, subject to the occurrence of the Effective Time, Fortress also agreed to forgo any further payment, dividend or distribution, or issuance or transfer of securities by Checkpoint on or after the date of the Support Agreement pursuant to the Amended and Restated Founders Agreement, dated as of July 11, 2016, between Fortress and Checkpoint and certain other agreements between Fortress and Checkpoint.
The Support Agreement also includes certain representations and warranties and covenants of Fortress to Parent, including certain restrictive covenants that apply to Fortress following the Effective Time.
As of March 9, 2025, Fortress beneficially owned an aggregate of approximately 11.2% of the outstanding Shares (consisting of 6,222,249 shares of common stock and 700,000 shares of Class A common stock) and controlled a majority of the outstanding voting power of Checkpoint’s capital stock through its ownership of all outstanding shares of Checkpoint’s Class A common stock. The Support Agreement will terminate upon termination of the Merger Agreement, the Effective Time and certain other specified events.
Royalty Agreement
Concurrently with the execution of the Merger Agreement, Checkpoint entered into a Royalty Agreement (the “Royalty Agreement”) with Parent and Fortress pursuant to which following, and subject to the occurrence of, the Effective Time, Fortress will receive a royalty interest right based on worldwide net sales of certain products of Checkpointand Parent. The royalty interest right represents the right to receive quarterly cash payments of 2.5% of net sales of such products during the time period set forth in the Royalty Agreement.
Transition Services Agreement
Pursuant to the Merger Agreement, as of or prior to the Effective Time, Checkpoint and Fortress will enter into a Transition Services Agreement (the “Transition Services Agreement”), pursuant to which, from and after the Effective Time, Fortress would provide Checkpoint with certain transition services as set forth in the Transition Services Agreement, for the period of time and in exchange for the compensation set forth therein.
March 2025 Warrant Exercise – Checkpoint
In March 2025, Checkpoint received approximately $36.0 million from the exercise of warrants for the issuance of 21,691,003 shares of common stock with an average exercise price of $1.66 per share.
February 2025 Public Offering - Mustang
In February 2025, Mustang closed on an equity offering of 2,657,807 shares of common stock (or common stock equivalent in lieu thereof ) and Series C-1 warrants to purchase up to 2,657,807 shares of common stock and Series C-2 warrants to purchase up to 2,657,807 shares of common stock at a combined public offering price of $3.01 per share (or per common stock equivalent in lieu thereof). The warrants have an exercise price of $3.01 per share and will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares upon exercise of the warrants. The Series C-1 warrants will expire five years from the date of stockholder approval and the Series C-2 warrants will expire twenty-four months from the date of stock holder approval. The warrants contain customary anti-dilution adjustments to the exercise price, including share splits, share dividends, rights offerings and pro rata distributions. The net proceeds of the equity offering, after deducting the fees and expenses of the placement agent and other offering expenses payable by Mustang were $6.9 million.
Lease Amendment – Mustang
In February 2025, Mustang concurrently exited the lease of its manufacturing facility in Worcester, Massachusetts, relocating their corporate headquarters to 95 Sawyer Road, Waltham, Massachusetts, and divested certain fixed assets including furniture and equipment to AbbVie Bioresearch Center, Inc. for $1.0 million.
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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| Fortress Biotech, Inc. | |||
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| March 31, 2025 | | By: | /s/ Lindsay A. Rosenwald, M.D. |
| | Lindsay A. Rosenwald, M.D. | ||
| | Chairman, President and Chief Executive Officer(Principal Executive Officer) | ||
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
| Signature | Title | Date | ||
|---|---|---|---|---|
| /s/ Lindsay A. Rosenwald, M.D. | Chairman of the Board of Directors, President and Chief | March 31, 2025 | ||
| Lindsay A. Rosenwald, M.D. | Executive Officer (Principal Executive Officer) | |||
| /s/ David Jin | Chief Financial Officer | March 31, 2025 | ||
| David Jin | (Principal Financial Officer and Principal Accounting Officer) | |||
| /s/ Michael S. Weiss | Executive Vice Chairman, Strategic Development and | March 31, 2025 | ||
| Michael S. Weiss | Director | |||
| /s/ Jimmie Harvey, Jr., M.D. | Director | March 31, 2025 | ||
| Jimmie Harvey, Jr., M.D. | ||||
| /s/ Malcolm Hoenlein | Director | March 31, 2025 | ||
| Malcolm Hoenlein | ||||
| /s/ Dov Klein | Director | March 31, 2025 | ||
| Dov Klein | ||||
| /s/ J. Jay Lobell | Director | March 31, 2025 | ||
| J. Jay Lobell | ||||
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| /s/ Kevin L. Lorenz, J.D. | Director | March 31, 2025 | ||
| Kevin Lorenz | ||||
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| /s/ Lucy Lu, M.D. | Director | March 31, 2025 | ||
| Lucy Lu, M.D. | ||||
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The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.