Fortress Biotech Inc
For the period ended Mar 31, 2024. Filed May 15, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2024 · Filed May 15, 2024
Extracted filing text, with the paragraph anchors used by the comparison.
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Item 1. Unaudited Condensed Consolidated Financial Statements
Unaudited Condensed Consolidated Balance Sheets
($ in thousands except for share and per share amounts)
| | | | | | | |
|---|---|---|---|---|---|---|
| · · March 31, · · December 31, | ||||||
| · · 2024 · · 2023 | ||||||
| · · · · | ||||||
| ASSETS · · | ||||||
| Current assets · · | ||||||
| Cash and cash equivalents | | $83,774 | | $80,927 | ||
| Accounts receivable, net | | 9,799 | | 15,222 | ||
| Inventory | | 10,580 | | 10,206 | ||
| Other receivables - related party | | 324 | | 167 | ||
| Prepaid expenses and other current assets | | 12,071 | | 10,500 | ||
| Total current assets | | 116,548 | | 117,022 | ||
| | | | | | | |
| Property, plant and equipment, net | | 6,128 | | 6,505 | ||
| Operating lease right-of-use asset, net | | 16,462 | | 16,990 | ||
| Restricted cash | | 2,063 | | 2,438 | ||
| Intangible assets, net | | 19,473 | | 20,287 | ||
| Other assets | | 3,971 | | 4,284 | ||
| Total assets | | $164,645 | | $167,526 | ||
| | | | | | | |
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | | | ||||
| Current liabilities | | | | | ||
| Accounts payable and accrued expenses | | $76,379 | | $73,562 | ||
| Income taxes payable | | | 843 | | | 843 |
| Common stock warrant liabilities | | | 689 | | | 886 |
| Operating lease liabilities, short-term | | 2,601 | | 2,523 | ||
| Partner company convertible preferred shares, short-term, net | | | 4,021 | | | 3,931 |
| Partner company installment payments - licenses, short-term, net | | | 3,000 | | | 3,000 |
| Other short-term liabilities | | | 163 | | | 163 |
| Total current liabilities | | 87,696 | | 84,908 | ||
| | | | | | | |
| Notes payable, long-term, net | | 61,420 | | 60,856 | ||
| Operating lease liabilities, long-term | | 17,619 | | 18,282 | ||
| Other long-term liabilities | | 1,847 | | 1,893 | ||
| Total liabilities | | | 168,582 | | | 165,939 |
| | | | | | ||
| Commitments and contingencies (Note 14) | | | ||||
| | | | | | | |
| Stockholders’ equity (deficit) | | | ||||
| Cumulative redeemable perpetual preferred stock, $0.001 par value, 15,000,000 authorized, 5,000,000 designated Series A shares, 3,427,138 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively, liquidation value of $25.00 per share | | 3 | | 3 | ||
| Common stock, $0.001 par value, 200,000,000 shares authorized, 19,375,343 and 15,093,053 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively | | 19 | | 15 | ||
| Additional paid-in-capital | | 733,290 | | 717,396 | ||
| Accumulated deficit | | (710,287) | | (694,870) | ||
| Total stockholders' equity attributed to the Company | | 23,025 | | 22,544 | ||
| | | | | | | |
| Non-controlling interests | | (26,962) | | (20,957) | ||
| Total stockholders' equity (deficit) | | (3,937) | | 1,587 | ||
| Total liabilities and stockholders' equity (deficit) | | $164,645 | | $167,526 | ||
Unaudited Condensed Consolidated Statements of Operations
($ in thousands except for share and per share amounts)
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · · Three Months Ended March 31, · | |||||||
| · 2024 · 2023 | |||||||
| Revenue · · | |||||||
| Product revenue, net | | $13,030 | | $12,165 | | ||
| Collaboration revenue | | | — | | 181 | | |
| Revenue - related party | | — | | 35 | | ||
| Other revenue | | | — | | | 48 | |
| Net revenue | | 13,030 | | 12,429 | | ||
| | | | | | | | |
| Operating expenses | | | | | | ||
| Cost of goods sold - product revenue | | 6,816 | | 6,449 | | ||
| Research and development | | 24,839 | | 35,276 | | ||
| Research and development - licenses acquired | | — | | 4,230 | | ||
| Selling, general and administrative | | 17,941 | | 25,341 | | ||
| Total operating expenses | | 49,596 | | 71,296 | | ||
| Loss from operations | | (36,566) | | (58,867) | | ||
| | | | | | | | |
| Other income (expense) | | | | ||||
| Interest income | | 833 | | 1,036 | | ||
| Interest expense and financing fee | | (2,602) | | (4,296) | | ||
| Gain (loss) on common stock warrant liabilities | | (667) | | 6,678 | | ||
| Other income (expense) | | | (21) | | | 304 | |
| Total other income (expense) | | (2,457) | | 3,722 | | ||
| Net loss | | (39,023) | | (55,145) | | ||
| | | | | | | | |
| Net loss attributable to non-controlling interests | | 23,606 | | 33,608 | | ||
| Net loss attributable to Fortress | | $(15,417) | | $(21,537) | | ||
| | | | | | | | |
| Net loss attributable to common stockholders | | $(17,731) | | $(23,545) | | ||
| | | | | | | | |
| Net loss per common share attributable to common stockholders - basic and diluted | | $(1.03) | | $(3.47) | | ||
| | | | | | | | |
| Weighted average common shares outstanding - basic and diluted | | 17,151,945 | | 6,792,376 | | ||
Unaudited Condensed Consolidated Statement of Changes in Stockholders’ Equity (Deficit)
($ in thousands except for share amounts)
For the Three Months Ended March 31, 2024
| | | | | | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| | | | | | | | | | | | | | | | | | | | | | | |
| · · Series A Perpetual · · · · · · · · · · · · · · Total | ||||||||||||||||||||||
| · · Preferred Stock · · Common Stock · · Paid-In · · Accumulated · · Non-Controlling · · Stockholders’ | ||||||||||||||||||||||
| · Shares · Amount · Shares · Amount · Capital · Deficit · Interests · Equity (Deficit) | ||||||||||||||||||||||
| Balance as of December 31, 2023 | 3,427,138 | $3 | 15,093,053 | $15 | $717,396 | $(694,870) | $(20,957) | $1,587 | ||||||||||||||
| Stock-based compensation expense | — | | — | — | | — | | 4,857 | | — | | — | | 4,857 | ||||||||
| Issuance of common stock related to equity plans | — | | — | 461,468 | | — | | — | | — | | — | | — | ||||||||
| Issuance of common stock for public offering, net | | | | | | | 3,303,305 | | | 4 | | | 10,115 | | | | | | | | | 10,119 |
| Issuance of common stock for at-the-market offering, net | | — | | | — | | 462,200 | | — | | | 894 | | — | | | — | | | 894 | ||
| Common shares issued for dividend on partner company's convertible preferred shares | — | | — | 37,817 | | — | | 68 | | — | | — | | 68 | ||||||||
| Preferred A dividends declared and paid | — | | — | — | | — | | (2,008) | | — | | — | | (2,008) | ||||||||
| Partner companies' offerings, net | — | | — | — | | — | | 12,636 | | — | | — | | 12,636 | ||||||||
| Partner company’s at-the-market offering, net | — | | — | — | | — | | 1,484 | | — | | — | | 1,484 | ||||||||
| Issuance of common stock under partner company’s ESPP | | — | | — | — | | — | | 133 | | — | | — | | | 133 | ||||||
| Partner company’s dividends declared and paid | — | | — | — | | — | | (176) | | — | | — | | (176) | ||||||||
| Partner companies' proceeds from options and warrants, net | — | | — | — | | — | | 5,461 | | — | | — | | 5,461 | ||||||||
| Exercise of warrants for cash | — | | — | 17,500 | | — | | 30 | | — | | — | | 30 | ||||||||
| Non-controlling interest in partner companies | | — | | — | — | | — | | (17,600) | | — | | 17,600 | | | — | ||||||
| Net loss attributable to non-controlling interest | | — | | — | — | | — | | — | | — | | (23,605) | | | (23,605) | ||||||
| Net loss attributable to common stockholders | — | | — | — | | — | | — | | (15,417) | | — | | (15,417) | ||||||||
| Balance as of March 31, 2024 | 3,427,138 | $3 | 19,375,343 | $19 | $733,290 | $(710,287) | $(26,962) | $(3,937) | ||||||||||||||
Unaudited Condensed Consolidated Statement of Changes in Stockholders’ Equity
($ in thousands except for share amounts)
For the Three Months Ended March 31, 2023
| · · · · · · · · · · · · · · · · · · · · · · | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Series A Perpetual · · · · · · · · · · · · · · · Total | ||||||||||||||||||||
| · · Preferred Stock · · Common Stock · · Paid-In · · Accumulated · · Non-Controlling · · Stockholders’ | ||||||||||||||||||||
| · Shares · Amount · Shares · Amount · Capital · Deficit · Interests · Equity | ||||||||||||||||||||
| Balance as of December 31, 2022 | 3,427,138 | $3 | 7,366,283 | $7 | | $675,944 | $(634,233) | | $8,304 | $50,025 | ||||||||||
| Stock-based compensation expense | — | | — | — | | — | | 4,731 | | — | | — | | 4,731 | ||||||
| Issuance of common stock related to equity plans | — | | — | 178,341 | | — | | — | | — | | — | | — | ||||||
| Issuance of common stock for public offering, net | — | | — | 1,109,526 | | 1 | | 13,193 | | — | | — | | 13,194 | ||||||
| Issuance of common stock for at-the-market offering, net | | — | | | — | | 40,326 | | — | | | 447 | | — | | | — | | | 447 |
| Preferred A dividends declared and paid | — | | — | — | | — | | (2,008) | | — | | — | | (2,008) | ||||||
| Partner company’s offering, net | — | | — | — | | — | | 7,518 | | — | | — | | 7,518 | ||||||
| Partner company’s dividends declared and paid | — | | — | — | | — | | (186) | | — | | — | | (186) | ||||||
| Issuance of partner company’s common shares for research and development expenses | — | | — | — | | — | | 1,230 | | — | | — | | 1,230 | ||||||
| Non-controlling interest in partner companies | | — | | — | — | | — | | (7,314) | | — | | 7,314 | | | — | ||||
| Net loss attributable to non-controlling interest | | — | | — | — | | — | | — | | — | | (33,608) | | | (33,608) | ||||
| Net loss attributable to common stockholders | — | | — | — | | — | | — | | (21,537) | | — | | (21,537) | ||||||
| Balance as of March 31, 2023 | | 3,427,138 | $3 | 8,694,476 | $8 | | $693,555 | $(655,770) | | $(17,990) | $19,806 | |||||||||
Unaudited Condensed Consolidated Statements of Cash Flows
($ in thousands)
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Three Months Ended March 31, | ||||||
| · 2024 · 2023 | ||||||
| Cash Flows from Operating Activities: · · | ||||||
| Net loss | | $(39,023) | | $(55,145) | ||
| Reconciliation of net loss to net cash used in operating activities: | | | | |||
| Depreciation expense | | 377 | | 844 | ||
| Bad debt expense | | | 6 | | 126 | |
| Amortization of debt discount | | 609 | | 644 | ||
| Accretion of partner company convertible preferred shares | | 45 | | 198 | ||
| Non-cash interest | | | — | | | 91 |
| Amortization of acquired intangible assets | | 814 | | 1,069 | ||
| Reduction in the carrying amount of operating lease right-of-use assets | | 528 | | 524 | ||
| Stock-based compensation expense | | 4,857 | | 4,731 | ||
| Loss on partner company warrant issuance | | 574 | | — | ||
| Common shares issued for dividend on partner company's convertible preferred shares | | | 68 | | | — |
| Change in fair value of partner companies' warrant liabilities | | 93 | | (6,678) | ||
| Research and development - licenses acquired, expense | | — | | 4,230 | ||
| Increase (decrease) in cash and cash equivalents resulting from changes in operating assets and liabilities: | | | | |||
| Accounts receivable | | 5,417 | | 466 | ||
| Inventory | | (374) | | 881 | ||
| Other receivables - related party | | (157) | | (498) | ||
| Prepaid expenses and other current assets | | (1,571) | | 1,199 | ||
| Other assets | | 313 | | 30 | ||
| Accounts payable and accrued expenses | | 2,668 | | 4,774 | ||
| Deferred revenue | | | — | | | (181) |
| Lease liabilities | | (585) | | (478) | ||
| Other long-term liabilities | | (46) | | (47) | ||
| Net cash used in operating activities | | (25,387) | | (43,220) | ||
| | | | | | | |
| Cash Flows from Investing Activities: | | | ||||
| Acquisition of VYNE products | | | — | | | (5,000) |
| Net cash used in investing activities | | — | | (5,000) | ||
Unaudited Condensed Consolidated Statements of Cash Flows
($ in thousands)
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Three Months Ended March 31, | ||||||
| · · 2024 · · 2023 | ||||||
| Cash Flows from Financing Activities: · · | ||||||
| Payment of Series A perpetual preferred stock dividends | $(2,008) | $(2,008) | ||||
| Proceeds from issuance of common stock for public offering, net | | | 10,119 | | | 13,325 |
| Proceeds from issuance of common stock for at-the-market offering, net | | | 894 | | | 447 |
| Exercise of warrants for cash | | | 30 | | | — |
| Proceeds from partner companies' ESPP | | | 133 | | — | |
| Partner company’s dividends declared and paid | | | (176) | | (186) | |
| Proceeds from partner companies' sale of stock and warrants, net | | | 12,786 | | | 9,905 |
| Proceeds from partner companies' at-the-market offering, net | | 1,484 | | — | ||
| Proceeds from partner company convertible preferred shares, net | | | — | | | 652 |
| Proceeds from exercise of partner companies’ options and warrants, net | | | 4,597 | | | — |
| Proceeds from partner company's line of credit | | | — | | | 28,000 |
| Repayment of partner company's line of credit | | | — | | | (27,948) |
| Net cash (used in) provided by financing activities | | 27,859 | | 22,187 | ||
| Net increase (decrease) in cash and cash equivalents and restricted cash | | 2,472 | | (26,033) | ||
| Cash and cash equivalents and restricted cash at beginning of period | | 83,365 | | 180,954 | ||
| Cash and cash equivalents and restricted cash at end of period | | $85,837 | | $154,921 | ||
| | | | | | | |
| Supplemental disclosure of cash flow information: | | | | | ||
| Cash paid for interest | | $1,658 | | $2,885 | ||
| Cash paid (refunded) for income taxes | | $— | | $(104) | ||
| | | | | | | |
| Supplemental disclosure of non-cash financing and investing activities: | | | ||||
| Settlement of restricted stock units into common stock | | $— | | $3 | ||
| Unpaid fixed assets | | $— | | $18 | ||
| Unpaid partner company’s offering cost | | $150 | | $156 | ||
| Partner company derivative warrant liability associated with partner company convertible preferred shares | | $— | | $33 | ||
| Prepaid public offering cost | | $— | | $94 | ||
| Unpaid public offering cost | | $— | | $37 | ||
- 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 (“COH” or “City of Hope”), Fred Hutchinson Cancer Center, Dana-Farber Cancer Institute, Nationwide Children’s Hospital, Cincinnati Children’s Hospital Medical Center, 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 the partners 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 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 subsidiaries and partner companies that are pursuing development and/or commercialization of biopharmaceutical products and product candidates are: Avenue Therapeutics, Inc. (Nasdaq: ATXI, “Avenue”), Baergic Bio, Inc. (“Baergic”, a subsidiary of Avenue), Cellvation, Inc. (“Cellvation”), Checkpoint Therapeutics, Inc. (Nasdaq: CKPT, “Checkpoint”), Cyprium Therapeutics, Inc. (“Cyprium”), Helocyte, Inc. (“Helocyte”), Journey Medical Corporation (Nasdaq: DERM, “Journey” or “JMC”), Mustang Bio, Inc. (Nasdaq: MBIO, “Mustang”), 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 substantial losses for the next several years as it continues to fully develop and prepare regulatory filings and obtain regulatory approvals for its existing and new product candidates. The parent Company’s current cash and cash equivalents of $43.9 million are sufficient to fund the parent entity and private subsidiary operations for at least the next 12 months. However, the Company will need to raise additional funding through strategic relationships, public or private equity or debt financings, sale of partner companies, 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 accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited interim condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results for the periods presented. Certain information and footnote disclosures normally included in the Company’s annual financial statements prepared in accordance with GAAP have been condensed or omitted. These condensed consolidated financial statement results are not necessarily indicative of results to be expected for the full fiscal year or any future period.
The unaudited condensed consolidated financial statements and related disclosures have been prepared with the presumption that users of the unaudited condensed consolidated financial statements have read or have access to the audited financial statements for the preceding fiscal year for each of Avenue, Checkpoint, Mustang and Journey. Accordingly, these unaudited condensed consolidated financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K, which was filed with the United States Securities and Exchange Commission (“SEC”) on March 28, 2024 (the “2023 Form 10-K”), from which the Company derived the balance sheet data at December 31, 2023, as well as Checkpoint’s Form 10-K, filed with the SEC on March 22, 2024, Mustang’s Form 10-K, filed with the SEC on March 11, 2024, Avenue’s Form 10-K, filed with the SEC on March 18, 2024, and Journey’s Form 10-K, filed with the SEC on March 29, 2024.
The Company’s unaudited condensed 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.
Use of Estimates
The preparation of the Company’s unaudited condensed 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 unaudited condensed 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 product returns, coupons, rebates, chargebacks, discounts, allowances and distribution fees paid by Journey to certain wholesalers, 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.
Restricted Cash
The Company records cash held in trust or pledged to secure certain debt obligations as restricted cash. As of March 31, 2024 and December 31, 2023, the Company had $2.1 million and $2.4 million, respectively, of restricted cash representing pledges to secure debt obligations and 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 unaudited condensed consolidated balance sheets to the unaudited condensed consolidated statements of cash flows as of the dates presented:
| · · · · · · | ||||
|---|---|---|---|---|
| · · March 31, | ||||
| | | 2024 | | 2023 |
| Cash and cash equivalents | $83,774 | $152,483 | ||
| Restricted cash | | 2,063 | | 2,438 |
| Total cash and cash equivalents and restricted cash | | $85,837 | | $154,921 |
Significant Accounting Policies
There have been no material changes in the Company’s significant accounting policies to those previously disclosed in the 2023 Form 10-K.
Recently Issued Accounting Pronouncements
Accounting Standards Note Yet Adopted
In November 2023, the FASB issued ASU No. 2023-07,Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires that an entity report segment information in accordance with Topic 280, Segment Reporting. The amendment in the ASU is intended to improve reportable segment disclosure requirements primarily through enhanced disclosures about significant segment expenses. The amendments in this update are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The Company is currently evaluating the impact of the new standard on its financial statements and disclosures.
In December 2023, the FASB issued ASU No. 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 that this guidance will have on its financial statements and disclosures.
- Asset Purchase Agreements
Mustang
Agreements with uBriGene (Boston) Biosciences, Inc. (“uBriGene”)
On May 18, 2023, Mustang entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) with uBriGene, as amended by a first amendment thereto, dated June 29, 2023, and further amended by a second amendment thereto, dated as of July 28, 2023 (collectively the “Amended Asset Purchase Agreement”), pursuant to which Mustang agreed, subject to the terms and conditions therein, to sell its leasehold interest in its cell processing facility located in Worcester, MA (the “Facility”) and associated assets relating to the manufacturing and production of cell and gene therapies at the Facility to uBriGene. On July 28, 2023, the closing date, pursuant to the terms and conditions of the Amended Asset Purchase Agreement, Mustang completed the sale of Mustang’s assets primarily relating to the manufacturing and production of cell and gene therapies to uBriGene for base consideration of $6.0 million. Mustang recorded a gain of $1.5 million in connection with the sale of the assets, and recorded approximately $0.3 million of the base consideration as deferred income, to be recognized upon the transfer of the lease. Certain assets, including Mustang’s lease of the Facility and related contracts did not transfer to uBriGene on the Closing date.
The Asset Purchase Agreement contemplates that Mustang will seek to procure the consent and approval of the landlord of the Facility, WCS-377 Plantation Street, Inc. (the “Landlord”), and the Landlord informed Mustang that it would not consider the lease transfer request until receipt of the final determination letter from with the U.S. Committee on Foreign Investment in the United States (“CFIUS”). In connection with the sale of its leasehold interest in the Facility and associated assets relating to the manufacturing and production of cell and gene therapies at the Facility (the “Facility Transaction”) to uBriGene and an indirect, wholly owned subsidiary of uBriGene (Jiangsu) Biosciences Co., Ltd., a Chinese contract development and manufacturing organization, Mustang and uBriGene previously submitted multiple voluntary notices to CFIUS.
As contemplated by the Amended Asset Purchase Agreement, on the Closing Date, Mustang and uBriGene entered into a Manufacturing Services Agreement (the “Manufacturing Services Agreement”). Under the Manufacturing Services Agreement, Mustang contracted uBriGene to manufacture Mustang’s lead product candidates, including MB-106, and Mustang committed to spend at least $8 million over a period oftwo years after the closing of the transaction to purchase manufacturing and related services (the “Manufacturing Services”) from uBriGene (the “Minimum Commitment”). Mustang paid uBriGene 25% of the Minimum Commitment at the time of signing of the Manufacturing Services Agreement. Mustang intends to expense manufacturing costs under the Manufacturing Services Agreement and the sub-contracting Manufacturing Services Agreement, pursuant to which uBriGene contracted with Mustang to perform the Manufacturing Services to be performed by uBriGene under the Manufacturing Services Agreement and account for reimbursed costs associated with the agreements as an offset to such expense.
In addition, as contemplated by the Asset Purchase Agreement, on the closing date, Mustang and uBriGene entered into a sub-contracting Manufacturing Services Agreement (the “Sub-Contracting CDMO Agreement”). Under the terms of the Sub-Contracting CDMO Agreement, Mustang would manufacture its lead product candidates, including MB-106, and may from time to time manufacture other products as requested by uBriGene. In addition, under the Sub-Contracting CDMO Agreement, Mustang and uBriGene agreed to establish a joint steering committee comprising two representatives from each of Mustang and uBriGene to review, discuss and decide on operational matters relating to the services to be performed by Mustang under such agreement, including matters relating to expenses.
Because the Facility was not assigned to uBriGene within 120 days following July 28, 2023, so long as the lease has not been so assigned, uBriGene may deliver a notice to Mustang indicating its intention to enter into good faith negotiations (the “Repurchase Notice”) to provide for Mustang to repurchase the associated assets relating to the manufacturing and production of cell and gene therapies at the Facility (the “Equipment”), re-assume the transferred liabilities and resume all transferred operations. Upon receipt of such Repurchase Notice, Mustang and uBriGene have agreed to use our best commercial efforts to negotiate in good faith the terms of any such Repurchase Transaction.
On May 13, 2024, Mustang, uBriGene and CFIUS executed a National Security Agreement (the “NSA”), pursuant to which Mustang and uBriGene agreed to abandon the Facility Transaction and all other transactions contemplated by the Amended Asset Purchase Agreement and the agreements entered into in connection therewith. The NSA imposes certain conditions on the Company and uBriGene and its affiliates. Most significantly, Mustang agreed (i) not to effect the Facility Transaction with uBriGene or any of its affiliates; and (ii) to appoint a Point of Contact representative with whom CFIUS and uBriGene’s designated contact person may interact as needed. The NSA also obligates uBriGene to sell, or otherwise dispose of, the equipment assets purchased within 180 days after execution of the NSA, with uBriGene able to eliminate some of its obligations under the NSA if it is able to sell the equipment assets purchased back to Mustang within 45 days after signing.
Avenue
InvaGen Pharmaceuticals Inc. (“InvaGen”) Share Repurchase
Under the Share Repurchase Agreement between Avenue and InvaGen Pharmaceuticals, Inc. (“InvaGen”) under which Avenue repurchased all of InvaGen’s shares in Avenue, Avenue agreed to pay InvaGen an additional amount as a contingent fee, payable in the form of seven and a half percent (7.5%) of the proceeds of future financings, until $4.0 million in the aggregate is paid to InvaGen. In connection with the closing of the January 2024 Warrant Inducement (as defined below, see Note 6), Avenue made a payment of $0.3 million to InvaGen. In connection with the May 2024 Warrant Inducement (as defined below, see Note 19), Avenue made a payment of $0.3 million to InvaGen.
4. Inventory
| | | | | | |
|---|---|---|---|---|---|
| · March 31, · · December 31, | |||||
| ($ in thousands) · 2024 · · 2023 | |||||
| Raw materials | $4,180 | | $4,640 | ||
| Work-in-process | 805 | | 884 | ||
| Finished goods | 5,865 | | 4,987 | ||
| Inventory reserve | | (270) | | | (305) |
| Total inventories | $10,580 | | $10,206 | ||
- Property and Equipment
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · Useful Life · March 31, · · December 31, | |||||||||
| ($ in thousands) · · (Years) · · 2024 · · 2023 | |||||||||
| · · | |||||||||
| Computer equipment | | 3 | | $595 | | $595 | |||
| Furniture and fixtures | | 5 | | 1,017 | | 1,017 | |||
| Machinery & equipment | | 5 | | — | | — | |||
| Leasehold improvements | | 15 | | 13,175 | | 13,175 | |||
| Buildings | | | 40 | | | 581 | | | 581 |
| Construction in progress | | N/A | | 29 | | 29 | |||
| Total property and equipment | | | | | 15,397 | | 15,397 | ||
| Less: Accumulated depreciation | | | | | (9,269) | | (8,892) | ||
| Property and equipment, net | | | | | $6,128 | | $6,505 | ||
Fortress' depreciation expense for the three months ended March 31, 2024 and 2023 was approximately $0.4 million and $0.8 million, respectively. Fortress’ depreciation expense is recorded in both research and development expense and general and administrative expense in the condensed consolidated statement of operations.
- Fair Value Measurements
Common Stock Warrant Liabilities
| | | | |
|---|---|---|---|
| · · Warrants | |||
| ($ in thousands) | liabilities | ||
| Balance at December 31, 2023 | | $886 | |
| Change in fair value of common stock warrants - Avenue | | | 116 |
| Change in fair value of common stock warrants - Checkpoint | | | — |
| Change in fair value of placement agent warrants - Urica | | | (24) |
| Exercise of common stock warrants - Avenue | | | (289) |
| Balance at March 31, 2024 | | $689 | |
Checkpoint
At March 31, 2024 and December 31, 2023, the Checkpoint warrant liability relates to the placement agent warrants from a registered direct offering completed in December 2022 (the “December 2022 Placement Agent Warrants”). Checkpoint deemed the 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 Placement Agent Warrants were recorded at the time of closing at a fair value determined by using the Black-Scholes model. Checkpoint will revalue the December 2022 Placement Agent Warrants at each reporting period thereafter for as long as they remain outstanding. At March 31, 2024 and December 31, 2023, the liability associated with the December 2022 Placement Agent Warrants was $0.1 million.
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:
| | | | | | | | | |
|---|---|---|---|---|---|---|---|---|
| · · March 31, · · December 31, · · | ||||||||
| Checkpoint Warrants · · 2024 · · 2023 · · | ||||||||
| Exercise price | | $5.41 | | $5.41 | | | ||
| Volatility | | | 107.5% | | 96.4% | | ||
| Expected life | | | 3.7 | | | 4.0 | | |
| Risk-free rate | | | 4.2% | | 3.8% | | ||
Avenue
Avenue had previously 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”, and together with the October 2022 Warrants, 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. The Black-Scholes model was used to value the Avenue Warrants, at the time of issuance and when re-measured at each financial reporting date, up to exercise or expiration of the warrants, with any changes in fair value being recognized in change in fair value of warrant liabilities, a component of other income (expense) in the unaudited condensed consolidated statements of operations.
In January 2024, Avenue entered in a warrant inducement for the immediate exercise of certain outstanding warrants, including the January 2023 Warrants (see Note 13). Avenue revalued the January 2023 Warrants on January 5, 2024, resulting in a fair value of $0.3 million. Since no October 2022 Warrants were exercised or amended in the January 2024 warrant inducement transaction, they were revalued at March 31, 2024, and the $0.1 million increase in the fair value of the common stock warrant liability resulted in an offsetting loss on common stock warrant liabilities in the unaudited condensed consolidated statements of operations.
| | | | |
|---|---|---|---|
| · · Avenue | |||
| · · Warrant | |||
| ($ in thousands) · · Liability | |||
| Common Stock Warrant liabilities at December 31, 2023 | | $586 | |
| Exercise of Avenue common warrants | | | (289) |
| Change in fair value of common stock warrant liabilities | | | 116 |
| Common Stock Warrant liabilities at March 31, 2024 | | $413 | |
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:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| | | March 31, | | | December 31 | | |
| | | 2024 | | | 2023 | | |
| Stock price | | $ 11.10 | | | $ 12.00 | | |
| Risk-free interest rate | 4.21% | | 3.84% | | |||
| Expected dividend yield | — | | — | | |||
| Expected term in years | 3.50 | | 3.80 | | |||
| Expected volatility | 162% | | 148% | |
Urica
The fair value of Urica’s contingently issuable placement agent warrants in connection with Urica’s first close of its preferred offering in December 2022 was measured using a Monte Carlo simulation valuation methodology. A summary of the weighted average (in aggregate) significant unobservable inputs (Level 3 inputs) used in measuring Urica’s warrant liability that are categorized within Level 3 of the fair value hierarchy was as follows:
| · · · · · · | ||
|---|---|---|
| · · March 31, · · December 31, | ||
| · · 2024 · · 2023 | ||
| Risk-free interest rate | 4.33% | 3.93% |
| Expected dividend yield | — | — |
| Expected term in years | 0.25 | 0.5 |
| Expected volatility | 102.3% | 153.6% |
At March 31, 2024 and December 31, 2023 the value of Urica’s contingent payment warrant was approximately $0.2 million.
- Intangible Assets, net
The Company’s finite-lived intangible assets consist of intangible assets acquired by Journey. The table below provides a summary of the Journey intangible assets as of March 31, 2024 and December 31, 2023, respectively:
| | | | | | | | | |
|---|---|---|---|---|---|---|---|---|
| · · Estimated Useful · · March 31, · · December 31, | ||||||||
| ($ in thousands) · Lives (Years) · 2024 · 2023 | ||||||||
| · · · · · · · | ||||||||
| Intangible assets – product licenses | | 3 to 9 | | $37,925 | | $37,925 | ||
| Accumulated amortization | | (15,309) | | (14,495) | ||||
| Accumulated Impairment loss | | | | | (3,143) | | | (3,143) |
| Net intangible assets | | $19,473 | | $20,287 | ||||
For the three months ended March 31, 2024 and 2023, Journey’s amortization expense related to its product licenses was $0.8 million and $1.1 million, respectively. Journey records amortization expense related to its product licenses as a component of cost of goods sold on the unaudited condensed consolidated statement of operations.
The future amortization of these intangible assets is as follows:
| | | | |
|---|---|---|---|
| · · Total | |||
| ($ in thousands) | Amortization | ||
| Remainder of 2024 | | $2,443 | |
| December 31, 2025 | | 3,257 | |
| December 31, 2026 | | 2,471 | |
| December 31, 2027 | | | 1,775 |
| December 31, 2028 | | | 1,595 |
| Thereafter | | | 3,990 |
| Sub-total | | $15,531 | |
| Asset not yet placed in service | | | 3,942 |
| Total | | $19,473 | |
- License Agreements
In accordance with ASC 730-10-25-1, Research and Development, costs incurred in obtaining technology licenses are charged to research and development expense if the technology licensed has not reached technological feasibility and has no alternative future use. The licenses purchased by Fortress and its subsidiaries and partner companies require substantial completion of research and development, and regulatory and marketing approval efforts, in order to reach technological feasibility. As such, for the three months ended March 31, 2024 and 2023, the purchase price of the license acquired was classified as research and development-licenses acquired in the unaudited condensed consolidated statement of operations.
- Debt and Interest
Debt
Total debt consists of the following:
| | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|
| · March 31, · · December 31, · · | ||||||||||
| ($ in thousands) · · 2024 · · 2023 · · Interest rate · · Maturity | ||||||||||
| · · · · · · · · · | ||||||||||
| Oaktree Note | | $50,000 | | $50,000 | 11.0% | August - 2025 | ||||
| SWK Term Loan | | | 15,000 | | | 15,000 | | 15.1% | December - 2027 | |
| Less: Discount on notes payable | | | (3,580) | | | (4,144) | | | | |
| Total notes payable | | $61,420 | | $60,856 | ||||||
Oaktree Note
In August 2020, Fortress, as borrower, entered into a $60.0 million senior secured credit agreement with Oaktree Fund Administration, LLC and the lenders from time-to-time thereto (collectively, “Oaktree”) (the “Oaktree Agreement” and the debt thereunder, the “Oaktree Note”). The Oaktree Agreement contains 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 requires Journey’s annual revenue to be equal to or to exceed annual revenue projections set forth in the Oaktree Agreement. Failure by the Company or Journey, as applicable, to comply with the Oaktree Agreement covenants will result in an event of default, subject to certain cure rights of the Company. The Company was in compliance with all applicable covenants under the Oaktree Agreement as of March 31, 2024.
The Company is required to make quarterly interest-only payments until the fifth anniversary of the closing date, August 27, 2025, the “Maturity Date,” at which point the outstanding principal amount is due. The Company may voluntarily prepay the Oaktree Note at any time subject to a prepayment fee. The Company is required to make mandatory prepayments of the Oaktree Note under various circumstances as defined in the Oaktree Agreement. No mandatory prepayments were required in the three months ended March 31, 2024.
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. The remaining $5.0 million may be drawn upon request by Journey within 12 months after the SWK Closing Date. Loans under the Credit Facility (the “Term Loans”) mature on December 27, 2027. The Term Loans accrue interest which is payable quarterly in arrears. The Term Loans bear interest at a rate per annum equal to the three-month term SOFR (subject to a SOFR floor of 5%) plus 7.75%. The interest rate 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. If the total revenue of Journey, measured on a trailing twelve-month basis, is greater than $70.0 million as of December 31, 2025, principal repayment is not required until 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.
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 for the quarter ended March 31, 2024 was 15.1%.
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 March 31, 2024, Journey was in compliance with the financial covenants under the SWK Credit Facility.
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 Urica 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, Fair Value Measurements).
Dividends on the Urica Preferred Stock are 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 are recorded as interest expense. For the three month periods ended March 31, 2024 and 2023, the Company recorded expense of $0.1 million and $0.1 million associated with the Urica dividends owed on the outstanding Urica Preferred Stock.
Interest Expense
The following table shows the details of interest expense for all debt arrangements during the periods presented. Interest expense includes contractual interest, and fees include amortization of the debt discount and amortization of fees associated with loan transaction costs, amortized over the life of the loan:
| | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended March 31, | ||||||||||||||||||
| · · 2024 · · 2023 | ||||||||||||||||||
| ($ in thousands) · Interest · Fees · Total · Interest · Fees · Total | ||||||||||||||||||
| Oaktree Note | | | 1,390 | | | 502 | | | 1,892 | | | 1,390 | | | 424 | | | 1,814 |
| Partner company convertible preferred shares | | | 113 | | | 45 | | | 158 | | | 260 | | | 60 | | | 320 |
| Partner company installment payments - licenses | | | — | | | — | | | — | | | 91 | | | — | | | 91 |
| Partner company notes payable | | | 486 | | | 62 | | | 548 | | | 1,500 | | | 160 | | | 1,660 |
| Other | | 4 | | — | | 4 | | 79 | | 332 | | | 411 | |||||
| Total Interest Expense and Financing Fee | | $1,993 | | $609 | | $2,602 | | $3,320 | | $976 | | $4,296 | ||||||
- Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses consisted of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · March 31, · · December 31, | ||||||
| ($ in thousands) · 2024 · 2023 | ||||||
| · · · · · | ||||||
| Accounts payable | | $41,803 | | $34,810 | ||
| Accrued expenses: | | | ||||
| Professional fees | | | 1,963 | | | 1,681 |
| Salaries, bonus and related benefits | | 6,586 | | 8,531 | ||
| Research and development | | 5,222 | | 11,644 | ||
| Research and development - milestones | | 7,000 | | — | ||
| Accrued royalties payable | | 1,382 | | 2,015 | ||
| Accrued coupon and rebates | | 7,169 | | 9,987 | ||
| Return reserve | | | 2,806 | | | 4,077 |
| Other | | 2,448 | | 817 | ||
| Total accounts payable and accrued expenses | | $76,379 | | $73,562 | ||
- Non-Controlling Interests
The Company’s ownership interests in its consolidated subsidiaries at March 31, 2024 was similar to December 31, 2023.
- 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 and adjusted for 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 Common Stock equivalents. Diluted net loss per share is the same as the basic loss per share due to net losses in all periods. For the three months ended March 31, 2024, the effect on the net loss per share calculation from Series A Preferred dividends was $2.0 million and partner company deemed dividends was $0.3 million (see Note 13).
The following shares of potentially dilutive securities, weighted during the quarters ended March 31, 2024 and 2023, have been excluded from the computation of diluted weighted average shares outstanding, as the effect of including such securities would be anti-dilutive:
| · · · · | ||
|---|---|---|
| | | |
| | | Three Months Ended March 31, |
| · · 2024 · 2023 | ||
| Warrants to purchase Common Stock | 5,769,788 | 127,296 |
| Options to purchase Common Stock | 18,896 | 41,508 |
| Unvested Restricted Stock | 1,725,726 | 1,379,934 |
| Unvested Restricted Stock Units | 1,267 | 71 |
| Total | 7,515,677 | 1,548,809 |
- Stockholders’ Equity
Stock-based Compensation
As of March 31, 2024, the Company had the following equity compensation plans: the Fortress Biotech, Inc. 2013 Stock Incentive Plan, as amended (the “2013 Plan”), the Fortress Biotech, Inc. 2012 Employee Stock Purchase Plan (the “ESPP”) and the Fortress Biotech, Inc. Long Term Incentive Plan (“LTIP”). As of March 31, 2024, approximately 38,000 shares were available for issuance under the 2013 Plan.
The following table summarizes the stock-based compensation expense from stock option, employee stock purchase programs and restricted Common Stock awards and warrants for the three months ended March 31, 2024 and 2023:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · · Three Months Ended March 31, · | |||||||
| ($ in thousands) · 2024 · 2023 · | |||||||
| Fortress: | | | | | | | |
| Employee and non-employee awards | | $2,193 | | $2,437 | | ||
| Executive awards | | 224 | | 407 | | ||
| | | | | | | | |
| Partner Companies: | | | | | | | |
| Avenue | | 191 | | 11 | | ||
| Checkpoint | | 709 | | 969 | | ||
| Mustang | | 77 | | 235 | | ||
| Journey | | | 1,406 | | | 646 | |
| Other | | 57 | | 26 | | ||
| Total stock-based compensation expense | | $4,857 | | $4,731 | | ||
For the three months ended March 31, 2024 and 2023, approximately $1.1 million and $0.9 million, respectively, of stock-based compensation expense was included in research and development expenses in connection with equity grants made to employees and consultants and approximately $3.7 million and $3.8 million, respectively, was included in general and administrative expenses in connection with grants made to employees, members of the board of directors and consultants.
Stock Options
The following table summarizes Fortress stock option activities excluding activity related to Fortress subsidiaries and 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 | | | 216,000 | | |
| Options vested and expected to vest at March 31, 2024 | 558,896 | | $2.32 | | $216,000 | 6.77 | ||||
| Options vested and exercisable at March 31, 2024 | | 18,896 | | $20.55 | | $— | 1.76 | |||
| | | | | | | | | | | |
As of March 31, 2024, Fortress had $0.4 million in unrecognized stock-based compensation expense related to options which is expected to be recognized over the remaining weighted-average vesting period of 3.8 years.
Restricted Stock and Restricted Stock Units
The following table summarizes Fortress restricted stock awards and restricted stock units activities, excluding activities related to Fortress subsidiaries and partner companies:
| | | | | | |
|---|---|---|---|---|---|
| · · Weighted | |||||
| · · · · average grant | |||||
| · · Number of shares · · price | |||||
| Unvested balance at December 31, 2023 | | 1,458,700 | | $28.05 | |
| Restricted stock granted | | 444,261 | | | 3.01 |
| Restricted stock vested | | 607 | | | 36.89 |
| Restricted stock units vested | | (17,206) | | | 46.74 |
| Unvested balance at March 31, 2024 | | 1,886,362 | | $21.99 | |
As of March 31, 2024 and 2023, the Company had unrecognized stock-based compensation expense related to restricted stock and restricted stock unit awards of approximately $13.2 million and $19.6 million, respectively, which is expected to be recognized over the remaining weighted-average vesting period of 1.4 years and 2.1 years, respectively.
Warrants
The following table summarizes Fortress warrant activities, excluding activities related to Fortress subsidiaries and 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 | ||||
| Exercised | | (17,500) | | | 1.70 | | | | | |
| Outstanding as of March 31, 2024 | 5,769,788 | | $1.88 | | $1,692,750 | 4.66 | ||||
| Exercisable as of March 31, 2024 | 5,769,788 | | $1.88 | | $1,692,750 | 4.66 | ||||
Long-Term Incentive Program (“LTIP”)
On July 15, 2015, the Company’s stockholders approved the LTIP for the Company’s Chairman, President and Chief Executive Officer, Dr. Rosenwald, and Executive Vice Chairman, Strategic Development, Mr. Weiss (amended and restated with stockholder approval on June 7, 2017). 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 result in performance-based compensation that is deductible without limit under Section 162(m) of the Internal Revenue Code of 1986, as amended.
On January 1, 2024 and 2023, the Compensation Committee granted 216,465 shares each to Dr. Rosenwald and Mr. Weiss. These equity grants were made in accordance with the LTIP, and each award represents 1% of total outstanding shares of the Company as of the dates of such grants. The shares will vest in full if the employee is either in the service of the Company as an employee, Board member or consultant (or any combination of the foregoing) on the tenth anniversary of the LTIP, or the eligible employee has had an involuntary Separation from Service (as defined in the LTIP). The only other vesting condition – one based on achievement of an increase in the Company’s market capitalization – has already been achieved, with respect to each annual award under the LTIP. The shares awarded under the LTIP will also vest in full (and the Company’s repurchase option on each tranche of shares granted thereunder will accordingly lapse) upon the occurrence of a Corporate Transaction (as defined in the LTIP), if the eligible employee is in service to the Company on the date of such Corporate Transaction. 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 three months ended March 31, 2024 and 2023, the Company recorded stock compensation expense related to LTIP grants of approximately $1.7 million and $1.4 million, respectively, and for the three months ended March 31, 2024 and 2023, respectively, on the unaudited condensed consolidated statement of operations.
Capital Raises
2021 Shelf
On July 23, 2021, the Company filed a shelf registration statement (File No. 333-258145) on Form S-3, which was declared effective on July 30, 2021 (the "2021 Shelf"). Approximately $88.2 million of securities remain available for sale under the 2021 Shelf as of March 31, 2024.
At the Market Offering
During the three-month period ended March 31, 2024, the Company issued and sold approximately 0.5 million shares at an average price of $1.99 for gross proceeds of $0.9 million. During the three-month period ended March 31, 2023 the Company issued and sold approximately 40,000 shares at an average price of $11.43 for gross proceeds of $0.5 million.
Registered Direct Offering
In January 2024, Fortress closed on 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, are immediately exercisable, and will 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 $10.2 million.
Checkpoint 2023 Shelf Registration Statement
In March 2023, Checkpoint filed a shelf registration statement (File No. 333-270843) on Form S-3 (the “Checkpoint 2023 S-3”), which was declared effective May 5, 2023. Under the Checkpoint 2023 S-3, Checkpoint may sell up to a total of $150 million of its securities. As of March 31, 2024, approximately $77.7 million of the securities remains available for sale through the Checkpoint 2023 S-3.
Checkpoint Registered Direct Offering
In January 2024, Checkpoint closed on a registered direct offering (the “Checkpoint January 2024 Registered Direct Offering”) with a single institutional investor for the issuance and sale of 1,275,000 shares of its common stock and 6,481,233 pre-funded warrants. Each pre-funded warrant was exercisable forone share of Checkpoint common stock. The Checkpoint common stock and the pre-funded warrants were sold together with common stock warrants (the “Checkpoint January 2024 Common Warrants”) to purchase up to 7,756,233 shares of Checkpoint common stock, at a purchase price of $1.805 per share of common stock and $1.8049 per pre-funded warrant. The pre-funded warrants were funded in full at closing except for a nominal exercise price of $0.0001 and are exercisable commencing on the closing date and will terminate when such pre-funded warrants are exercised in full. 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 $12.8 million after deducting commissions and other transaction costs. As of May 7, 2024,3,825,233 pre-funded warrants from the Checkpoint January 2024 Registered Direct Offering were fully exercised.
Pursuant to the Company’s Founders Agreement with Checkpoint, Checkpoint issued to Fortress 2.5% of the aggregate number of shares of common stock issued in the registered direct offering noted above. Accordingly, Checkpoint issued 193,905 shares of common stock to Fortress at a weighted average price of $2.04 per share for the three months ended March 31, 2024.
Avenue 2021 Shelf Registration Statement
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 March 31, 2024, approximately $24.9 million of the securities remains available for sale through the Avenue 2021 S-3, subject to General Instruction I.B.6. of Form S-3.
Avenue 2024 Warrant Exercise 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 such that it was included in net loss attributable to common stockholders in the calculation of net loss per share in the condensed consolidated statement of operations (see Note 12).
Pursuant to the Company’s Founders Agreement with Avenue, Avenue issued to Fortress 2.5% of the aggregate number of shares of common stock issued in the warrant exercise noted above. Accordingly, Avenue recorded 5,513 shares of common stock as issuable to Fortress at a weighted average price of $14.25 per share for the three months ended March 31, 2024.
Mustang 2021 Shelf Registration Statement and At-the-Market Offering (the “Mustang ATM”)
On April 23, 2021, Mustang filed a shelf registration statement (File No. 333-255476) on Form S-3 (the “Mustang 2021 S-3”), which was declared effective on May 24, 2021. Under the Mustang 2021 S-3, Mustang may sell up to a total of$200 million of its securities. As of March 31, 2024, approximately $195.6 million of the Mustang 2021 S-3 remained available for sales of securities. The Mustang 2021 S-3 expires on May 24, 2024.
On July 2018, Mustang entered into an At-the-Market Issuance Sales Agreement (the “Mustang ATM”) relating to the sale of shares of common stock pursuant to the Mustang 2021 S-3. Under the Mustang ATM, Mustang pays the sales agents for the program a commission rate of up to 3.0% of the gross proceeds from the sale of any shares of common stock. On April 14, 2023, the Mustang ATM was amended to add the limitations imposed by General Instruction I.B.6 to Form S-3. During the three months ended March 31, 2024 and 2023, Mustang issuedno shares through the Mustang ATM.
Journey 2022 Shelf Registration Statement and At-the-Market Offering
On December 30, 2022, Journey filed a shelf registration statement on Form S-3 (File No. 333-269079) (the “Journey 2022 S-3”), which was declared effective on January 26, 2023. 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 entered into a sales agreement relating to the sale of shares of Journey’s common stock in an at-the-market offering (the “Journey ATM Sales Agreement”). In accordance with the terms of the Journey ATM 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. For the three months ended March 31, 2024, Journey issued and sold approximately 0.3 million shares of common stock at an average price of $5.28 per share for gross proceeds of $1.5 million under the Journey ATM Sales Agreement. At March 31, 2024,3,861,553 shares remain available for issuance under the Journey 2022 S-3.
- Commitments and Contingencies
During three months ended March 31, 2024 and 2023, the Company recorded the following as lease costs for the periods presented:
| · · · · · · · | ||||||
|---|---|---|---|---|---|---|
| | Three Months Ended March 31, | |||||
| ($ in thousands) · · 2024 · · 2023 · | ||||||
| Operating lease cost | | $640 | | $1,019 | | |
| Shared lease costs | | (523) | | | (515) | |
| Variable lease cost | | 216 | | | 201 | |
| Total lease expense | | $333 | | $705 | | |
The following tables summarize quantitative information about the Company’s operating leases, under the adoption of ASC Topic 842*, Leases*:
| · · · · · · · · | ||||||
|---|---|---|---|---|---|---|
| | Three Months Ended March 31, | |||||
| ($ in thousands) · · 2024 · · 2023 · | ||||||
| Operating cash flows from operating leases | | $(920) | | $(876) | | |
| Right-of-use assets exchanged for new operating lease liabilities | | $— | | $— | | |
| Weighted-average remaining lease term – operating leases (years) | | 4.1 | | 4.6 | | |
| Weighted-average discount rate – operating leases | | 6.5% | 6.6% | | ||
| | | | |
|---|---|---|---|
| | Future Lease | ||
| ($ in thousands) · · Liability | |||
| Nine Months Ended December 31, 2024 | | $2,876 | |
| Year Ended December 31, 2025 | | 3,799 | |
| Year Ended December 31, 2026 | | 3,535 | |
| Year Ended December 31, 2027 | | | 3,191 |
| Year Ended December 31, 2028 | | | 3,241 |
| Other | | 8,428 | |
| Total operating lease liabilities | | 25,070 | |
| Less: present value discount | | (4,850) | |
| Net operating lease liabilities, short-term and long-term | | $20,220 | |
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 and partner companies 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 seeing 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 (“Alexion”) in October 2021, is 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 is pending in the United States District Court for the Eastern District of Tennessee (the “UTRF Litigation”). UTRF brought claims against Caelum, for,inter alia, tortious interference and trade secret misappropriation. UTRF primarily alleges 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 has indemnification obligations of Caelum under certain circumstances, including for certain of Caelum’s legal expenses and potential damages arising out of the UTRF Litigation (with such indemnification capped in the aggregate as to Fortress at the amount of Caelum acquisition proceeds received by Fortress – approximately $57 million to date - and which, at Caelum’s election, may be satisfiable in the form of offsets against future amounts that Caelum may owe Fortress under the DOSPA). Caelum is defending the UTRF Litigation, with Fortress participating in such defense and maintaining a consent right over any potential settlements. Caelum’s legal fees and costs in defending the UTRF Litigation are being reimbursed by Fortress by distribution from a $15 million escrow account established concurrently with the acquisition of Caelum; Fortress considers the amount remaining in escrow to be in excess of the amount of its anticipated out-of-pocket indemnifiable costs and damages in the UTRF Litigation and therefore has not accrued any liability pertaining to this indemnity. Caelum and Fortress both believe the UTRF Litigation is without merit and intend to continue defending it vigorously (including exhausting all appeals if applicable). Caelum’s motion for summary judgment is currently pending, and a trial is scheduled for September 2024 with respect to any of UTRF’s claims that may survive summary judgment.
- Related Party Transactions
Founders Agreement
The Company has entered into Founders Agreements and, in some cases, exchange agreements with certain of its subsidiaries as described in the 2023 Form 10-K. The following table summarizes, by partner company/subsidiary, the effective date of the Founders Agreements and Payment-in-Kind (“PIK”) dividend or equity fee payable to the Company in accordance with the terms of the Founders Agreements, exchange agreements, and the subsidiaries' certificates of incorporation:
| | | | | | | |
|---|---|---|---|---|---|---|
| | | | | PIK Dividend as | | |
| | | | | a % of fully | | |
| | | | | diluted | | |
| | | | | outstanding | | Class of Stock |
| Partner Company/Subsidiary · Effective Date 1 · capitalization · Issued | ||||||
| Avenue | | February 17, 2015 | 2.5% | Common Stock | ||
| Baergic | | December 17, 2019 4 | | - | %2 | Common Stock |
| Cellvation | | October 31, 2016 | 2.5% | Common Stock | ||
| Checkpoint | | March 17, 2015 | - | %3 | Common Stock | |
| Cyprium | | March 13, 2017 | 2.5% | Common Stock | ||
| Helocyte | | March 20, 2015 | 2.5% | Common Stock | ||
| Mustang | | March 13, 2015 | 2.5% | Common Stock | ||
| Oncogenuity | | April 22, 2020 4 | | 2.5% | Common Stock | |
| Urica | | November 7, 2017 4 | 2.5% | Common Stock | ||
| Note 1: | Represents the effective date of each subsidiary’s Founders Agreement. Each PIK dividend and equity fee is payable on the annual anniversary of the effective date of the original Founders Agreement or has since been amended to January 1 of each calendar year. |
|---|
| Note 2: | Due to the November 2022 consummation of the Contribution Agreement between the Company and Avenue, Avenue is now eligible to receive the PIK dividend and equity fee payable by Baergic. |
|---|
| Note 3: | Instead of a PIK dividend, Checkpoint pays the Company an annual equity fee in shares of Checkpoint’s common stock equal to 2.5% of Checkpoint’s fully diluted outstanding capitalization. |
|---|
| Note 4: | Represents the Trigger Date, the date that the Fortress partner company/subsidiary first acquires, whether by license or otherwise, ownership rights in a product. |
|---|
Management Services Agreements
The Company has entered into Management Services Agreements (the “MSAs”) with certain of its partner companies/subsidiaries as described in the 2023 Form 10-K. The following table summarizes the effective date of each MSA and the annual consulting fee payable by the partner company/subsidiary to the Company in quarterly installments:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · · · Annual MSA Fee · | ||||||
| Partner Company/Subsidiary · Effective Date · (Income)/Expense · | ||||||
| Avenue | | February 17, 2015 | | 500 | | |
| Baergic1 | | March 9, 2017 | | — | | |
| Cellvation | | October 31, 2016 | | 500 | | |
| Checkpoint | | March 17, 2015 | | 500 | | |
| Cyprium | | March 13, 2017 | | 500 | | |
| Helocyte | | March 20, 2015 | | | 500 | |
| Mustang | | March 13, 2015 | | 500 | | |
| Oncogenuity | | February 10, 2017 | | | 500 | |
| Urica | | November 7, 2017 | | | 500 | |
| Fortress | | | | (4,000) | | |
| Consolidated (Income)/Expense | | | | $— | | |
| Note 1: | Pursuant to the Share Contribution Agreement between Fortress and Avenue, under which Baergic became a majority-controlled and owned subsidiary of Avenue, Fortress also assigned to Avenue the Founders Agreement previously between Fortress and Baergic, such that Baergic’s annual MSA is now payable to Avenue. |
|---|
Fees and Stock Grants 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 TG Therapeutics, Inc. (“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 also Executive Chairman and Chief Executive Officer of TGTX. Under the terms of the Agreement, TGTX reimburses 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 three months ended March 31, 2024 and 2023 the Company invoiced TGTX$0.6 million and$0.1 million, respectively. At March 31, 2024, approximately$36,000 is due from TGTX related to this arrangement.
Shared Services Agreement with Journey
On November 12, 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 also the Executive Chairman of Journey. Under the terms of the arrangement, Journey began reimbursing the Company for the salary and benefit costs associated with these employees based upon actual hours worked on Journey related projects following the completion of their initial public offering in November 2021. 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 three months ended March 31, 2024 and 2023, the Company’s employees have provided services to Journey totaling approximately $9,000 and $15,000, respectively. At March 31, 2024, the total related party receivable was $0.2 million, and primarily relates to reimbursable expenses incurred by Fortress on behalf of Journey.
Desk Share Agreement with TGTX
The Desk Share Agreement with TGTX, as amended, requires TGTX to pay its share of the average annual rent for office space in New York, NY, based on the actual percentage of the office space occupied by TGTX on a month-by-month basis. For the three months ended March 31, 2024 and 2023, the Company had paid $0.7 million and $0.8 million in rent, respectively, and in connection with the Company’s Desk Share Agreement with TGTX, has invoiced TGTX approximately $0.5 million and $0.5 million, respectively, for its prorated share of the rent base. At March 31, 2024, $0.2 million is due from TGTX related to this arrangement.
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 March 31, 2024, there are 300,600 shares of Cyprium PPS outstanding.
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, Cyprium’s copper histidinate product candidate. Upon the PRV Sale, each share of Cyprium PPS will be automatically redeemed in exchange for a payment equal to twice (2x) the $25.00 liquidation preference, plus* *accumulated and unpaid dividends to, but excluding, the redemption date.
An optional exchange to Fortress Series A Preferred Stock is available after 24 months from the issuance date so long as a sale of the PRV has not occurred. Additionally, if a PRV Sale has not occurred by September 30, 2024 the Cyprium PPS will either be automatically exchanged for Fortress Series A Preferred Stock or cash at the discretion of Fortress. The Cyprium PPS is fully and unconditionally guaranteed by Fortress.
- Segment Information
The Company operates intwo reportable segments, Dermatology Product Sales and Pharmaceutical and Biotechnology Product Development. The accounting policies of the Company are consistently applied to all segments. The following tables summarize, for the periods indicated, operating results from continued operations by reportable segment:
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · · · · · Pharmaceutical · · | |||||||||
| · · · · · and · · · | |||||||||
| · · Dermatology · · Biotechnology · · · | |||||||||
| · · Products · · Product · · · | |||||||||
| Three Months Ended March 31, 2024 · Sales · Development · Consolidated | |||||||||
| Net revenue | | $13,030 | | $— | | $13,030 | |||
| Cost of goods - product revenue | | (6,816) | | — | | (6,816) | |||
| Research and development | | (7,884) | | (16,955) | | (24,839) | |||
| Selling, general and administrative | | | (8,420) | | | (9,521) | | | (17,941) |
| Other expense | | (352) | | (2,105) | | (2,457) | |||
| Segment loss | | $(10,442) | | $(28,581) | | $(39,023) | |||
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · · · · · Pharmaceutical · · · | |||||||||
| · · · · · and · · · | |||||||||
| · · Dermatology · · Biotechnology · · · | |||||||||
| · · Products · · Product · · · | |||||||||
| Three Months Ended March 31, 2023 · Sales · Development · Consolidated | |||||||||
| Net revenue | | $12,213 | | $216 | | $12,429 | |||
| Cost of goods - product revenue | | (6,449) | | — | | (6,449) | |||
| Research and development | | (2,033) | | (37,473) | | (39,506) | |||
| Selling, general and administrative | | (13,291) | | | (12,050) | | | (25,341) | |
| Other expense | | | (575) | | 4,297 | | 3,722 | ||
| Segment loss | | $(10,135) | | $(45,010) | | $(55,145) | |||
The following tables summarize, for the periods indicated, total assets by reportable segment:
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · · · · · Pharmaceutical · · | |||||||||
| · · · · · and · · · | |||||||||
| ($ in thousands) · · Dermatology · · Biotechnology · · · | |||||||||
| · · Products · · Product · · · | |||||||||
| March 31, 2024 · Sales · Development · Total Assets | |||||||||
| Intangible assets, net | | $19,473 | | $— | | $19,473 | |||
| Tangible assets | | | 47,098 | | | 98,074 | | | 145,172 |
| Total segment assets | | $66,571 | | $98,074 | | $164,645 | |||
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · · · · · Pharmaceutical · · | |||||||||
| · · · · · and · · · | |||||||||
| ($ in thousands) · · Dermatology · · Biotechnology · · · | |||||||||
| · · Products · · Product · · · | |||||||||
| December 31, 2023 · Sales · Development · Total Assets | |||||||||
| Intangible assets, net | | $20,287 | | $— | | $20,287 | |||
| Tangible assets | | | 56,561 | | | 90,678 | | | 147,239 |
| Total segment assets | | $76,848 | | $90,678 | | $167,526 | |||
- Revenues from Contracts and Significant Customers
Disaggregation of Total Revenue
Journey has the following actively marketed products, Qbrexza, Accutane, Targadox, Ximino (until September 2023), Exelderm, Amzeeq, Luxamend and Zilxi. All of Journey’s product revenues are recorded in the U.S.
The table below summarizes the Company’s revenue for the periods presented:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Three Months Ended March 31, | ||||||
| | 2024 | 2023 | ||||
| Revenue | | | | | | |
| Qbrexza | | $5,017 | | $4,094 | ||
| Accutane | | | 5,819 | | | 4,648 |
| Amzeeq | | | 755 | | | 1,193 |
| Zilxi | | | 273 | | | 314 |
| Other / legacy product revenue | | | 1,166 | | | 1,916 |
| Collaboration revenue | | | — | | | 181 |
| Revenue – related party | | — | | 35 | ||
| Other revenue | | | — | | 48 | |
| Total net revenue | | $13,030 | | $12,429 | ||
Significant Customers
For the three-month periods ending March 31, 2024 and 2023, none of Journey’s dermatology products customers accounted for more than 10% of its total gross product revenue.
At March 31, 2024, one of Journey’s dermatology products customers accounted for more than 10% of its total accounts receivable balance at 14%. At December 31, 2023, one of the Company’s dermatology products customers accounted for more than 10% of its total accounts receivable balance at 13%.
- Income taxes
The Company and its subsidiaries are subject to US federal and state income taxes. Income tax expense is the total of the current year income tax due or refundable and the change in deferred tax assets and liabilities. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry-forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion, or all, of the deferred tax asset will not be realized.
The Company files a consolidated income tax return with subsidiaries for which the Company has an 80% or greater ownership interest. Subsidiaries 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.
Income tax expense for the three months ended March 31, 2024 and 2023 is based on the estimated annual effective tax rate, and includes interest related to unrecognized tax benefits. The Company expects a net deferred tax asset with a full valuation allowance and 0% estimated annual effective tax rate for 2024. No income tax expense was recognized for the three months ended March 31, 2024 or 2023.
19. Subsequent Events
Avenue
In April 2024, Avenue filed a Certificate of Amendment to its Third Amended and Restated Certificate of Incorporation (the “Amendment”) with the Secretary of State of the State of Delaware to effect a 1-for-75 reverse stock split (the “Reverse Stock Split”) of Avenue’s shares of common stock, $0.0001 par value. As a result of the Reverse Stock Split, every 75 shares of Avenue’s pre-reverse split common stock was combined and reclassified as one share of common stock. The Reverse Stock Split became effective on April 26, 2024, and Avenue’s common stock was quoted on the Nasdaq Stock Market on a post-split basis at the open of business on April 26, 2024. Avenue’s post-reverse split common stock has a new CUSIP number, 05360L403, but the par value and other terms of Avenue’s common stock were not affected by the Reverse Stock Split.
Also in April 2024, Avenue entered into definitive agreements for the immediate exercise of certain of its existing outstanding warrants to exercise for cash an aggregate of 689,680 warrants for 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.
In consideration for the immediate exercise of the warrants for cash, Avenue issued two new unregistered series of 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 warrants will have an exercise price of $6.20 per share, and terms ranging from eighteen months tofive years. Total gross proceeds to Avenue were approximately $4.4 million before deducting placement agent fees and other expenses payable by Avenue.
In May 2024, Avenue entered into an At-the-Market Offering Agreement (the "Offering Agreement") with H.C. Wainwright & Co. LLC ("Wainwright") under which Avenue may offer and sell, from time to time at its sole discretion, up to $3,850,000 of shares of its common stock, par value $0.0001 per share (the "Shares"), through or to Wainwright. The offer and sale of the Shares will be made pursuant to the base prospectus forming a part of the 2021 Shelf, and the related prospectus supplement dated May 10, 2024 (the "Registration Statement") filed with the SEC on such date pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the "Securities Act").
Mustang
In April 2024, Mustang’s board of directors approved a reduction in its workforce by approximately 81% of its employee base in order to reduce costs and preserve capital; the reduction occurred primarily in April and is expected to be substantially complete in the second quarter of 2024.
In May 2024, Mustang closed on a public offering of 16,877,638 shares of common stock (or common stock equivalents in lieu thereof), and 50,632,914 warrants with a combined public offering price of $0.237 per share (or per share common stock equivalent in lieu thereof) and accompanying warrants with an exercise price of $0.237 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. Total gross proceeds were $4.0 million. The net proceeds of the public offering, after deducting the fees and expenses of the placement agent and other offering expenses payable by Mustang, but excluding the net proceeds, if any, from the exercise of the warrants, was approximately $3.3 million.
Mustang also amended certain existing warrants to purchase up to 2,588,236 shares of common stock previously issued in October 2023 with an exercise price of $1.58 per share such that the amended warrants have a reduced exercise price of $0.237 per share, and have afive-year term from date of shareholder approval.
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