Fortress Biotech Inc
For the period ended Jun 30, 2024. Filed Aug 13, 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.
Jun 30, 2024 · Filed Aug 13, 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)
| | | | | | | |
|---|---|---|---|---|---|---|
| · · June 30, · · December 31, | ||||||
| · · 2024 · · 2023 | ||||||
| · · · · | ||||||
| ASSETS · · | ||||||
| Current assets · · | ||||||
| Cash and cash equivalents | | $76,201 | | $80,927 | ||
| Accounts receivable, net | | 10,465 | | 15,222 | ||
| Inventory | | 9,687 | | 10,206 | ||
| Other receivables - related party | | 224 | | 167 | ||
| Prepaid expenses and other current assets | | 4,649 | | 10,500 | ||
| Assets held for sale | | 2,209 | | — | ||
| Total current assets | | 103,435 | | 117,022 | ||
| | | | | | | |
| Property, plant and equipment, net | | 3,546 | | 6,505 | ||
| Operating lease right-of-use asset, net | | 14,626 | | 16,990 | ||
| Restricted cash | | 2,063 | | 2,438 | ||
| Intangible assets, net | | 18,658 | | 20,287 | ||
| Other assets | | 3,357 | | 4,284 | ||
| Total assets | | $145,685 | | $167,526 | ||
| | | | | | | |
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | | | ||||
| Current liabilities | | | | | ||
| Accounts payable and accrued expenses | | $68,921 | | $73,562 | ||
| Income taxes payable | | | 806 | | | 843 |
| Common stock warrant liabilities | | | 172 | | | 886 |
| Operating lease liabilities, short-term | | 2,481 | | 2,523 | ||
| Partner company convertible preferred shares, short-term, net | | | — | | | 3,931 |
| Partner company installment payments - licenses, short-term, net | | | 3,000 | | | 3,000 |
| Other short-term liabilities | | | 163 | | | 163 |
| Total current liabilities | | 75,543 | | 84,908 | ||
| | | | | | | |
| Notes payable, long-term, net | | 67,007 | | 60,856 | ||
| Operating lease liabilities, long-term | | 15,934 | | 18,282 | ||
| Other long-term liabilities | | 1,799 | | 1,893 | ||
| Total liabilities | | | 160,283 | | | 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 June 30, 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, 22,587,038 and 15,093,053 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | | 23 | | 15 | ||
| Additional paid-in-capital | | 739,086 | | 717,396 | ||
| Accumulated deficit | | (721,235) | | (694,870) | ||
| Total stockholders' equity attributed to the Company | | 17,877 | | 22,544 | ||
| | | | | | | |
| Non-controlling interests | | (32,475) | | (20,957) | ||
| Total stockholders' equity (deficit) | | (14,598) | | 1,587 | ||
| Total liabilities and stockholders' equity (deficit) | | $145,685 | | $167,526 | ||
Unaudited Condensed Consolidated Statements of Operations
($ in thousands except for share and per share amounts)
| | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended June 30, · · Six Months Ended June 30, · | |||||||||||||
| · 2024 · 2023 · 2024 · 2023 | |||||||||||||
| Revenue · · · · | |||||||||||||
| Product revenue, net | | $14,855 | | $16,961 | | $27,885 | | $29,126 | | ||||
| Collaboration revenue | | | — | | 183 | | | — | | | 364 | | |
| Revenue - related party | | 41 | | 31 | | 41 | | 66 | | ||||
| Other revenue | | | — | | | 211 | | | — | | | 259 | |
| Net revenue | | 14,896 | | 17,386 | | 27,926 | | 29,815 | | ||||
| | | | | | | | | | | | | | |
| Operating expenses | | | | | | | | | | ||||
| Cost of goods sold - product revenue | | 6,541 | | 7,767 | | 13,357 | | 14,216 | | ||||
| Research and development | | 12,671 | | 32,139 | | 37,495 | | 67,415 | | ||||
| Research and development - licenses acquired | | — | | 3 | | — | | 4,233 | | ||||
| Selling, general and administrative | | 20,823 | | 24,439 | | 38,777 | | 49,780 | | ||||
| Asset impairment | | | 2,649 | | | 3,143 | | | 2,649 | | | 3,143 | |
| Total operating expenses | | 42,684 | | 67,491 | | 92,278 | | 138,787 | | ||||
| Loss from operations | | (27,788) | | (50,105) | | (64,352) | | (108,972) | | ||||
| | | | | | | | | | | | | | |
| Other income (expense) | | | | | | ||||||||
| Interest income | | 734 | | 715 | | 1,567 | | 1,751 | | ||||
| Interest expense and financing fee | | (2,122) | | (6,425) | | (4,724) | | (10,721) | | ||||
| Change in fair value of warrant liabilities | | | — | | | (512) | | | — | | | 6,166 | |
| Gain (loss) on common stock warrant liabilities | | 70 | | — | | (597) | | — | | ||||
| Loss from deconsolidation of subsidiaries | | | — | | | (3,369) | | | — | | | (3,369) | |
| Other income (expense) | | | 282 | | | 395 | | | 260 | | | 699 | |
| Total other income (expense) | | (1,036) | | (9,196) | | (3,494) | | (5,474) | | ||||
| Net loss | | (28,824) | | (59,301) | | (67,846) | | (114,446) | | ||||
| | | | | | | | | | | | | | |
| Net loss attributable to non-controlling interests | | 17,876 | | 34,525 | | 41,481 | | 68,133 | | ||||
| Net loss attributable to Fortress | | $(10,948) | | $(24,776) | | $(26,365) | | $(46,313) | | ||||
| | | | | | | | | | | | | | |
| Net loss attributable to common stockholders | | $(13,339) | | $(26,917) | | $(31,199) | | $(50,595) | | ||||
| | | | | | | | | | | | | | |
| Net loss per common share attributable to common stockholders - basic and diluted | | $(0.73) | | $(3.65) | | $(1.76) | | $(7.14) | | ||||
| | | | | | | | | | | | | | |
| Weighted average common shares outstanding - basic and diluted | | 18,316,874 | | 7,377,332 | | 17,736,299 | | 7,086,482 | | ||||
For the Three Months Ended June 30, 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 March 31, 2024 | 3,427,138 | $3 | 19,375,343 | $19 | $733,290 | $(710,287) | $(26,962) | $(3,937) | ||||||||||||||
| Stock-based compensation expense | — | | — | — | | — | | 4,998 | | — | | — | | 4,998 | ||||||||
| Issuance of common stock related to equity plans | — | | — | 34,293 | | — | | — | | — | | — | | — | ||||||||
| Issuance of common stock under ESPP | — | | — | 29,844 | | — | | 51 | | — | | — | | 51 | ||||||||
| Issuance of common stock for at-the-market offering, net | | — | | | — | | 1,092,283 | | 1 | | | 1,930 | | — | | | — | | | 1,931 | ||
| Common shares issued for dividend on partner company's convertible preferred shares | — | | — | 26,930 | | — | | 46 | | — | | — | | 46 | ||||||||
| Common shares issued for exchange of partner company's convertible preferred shares | — | | — | 2,028,345 | | 3 | | 3,406 | | — | | — | | 3,409 | ||||||||
| Warrants issued in conjunction with exchange of partner company's convertible preferred shares | | | | | | | | | | | | | 341 | | | | | | | | | 341 |
| Preferred A dividends declared and paid | — | | — | — | | — | | (2,008) | | — | | — | | (2,008) | ||||||||
| Partner companies' offerings, net | — | | — | — | | — | | 5,265 | | — | | — | | 5,265 | ||||||||
| Partner company’s at-the-market offering, net | — | | — | — | | — | | 295 | | — | | — | | 295 | ||||||||
| Partner company’s dividends declared and paid | — | | — | — | | — | | (176) | | — | | — | | (176) | ||||||||
| Partner companies' proceeds from options and warrants, net | — | | — | — | | — | | 4,010 | | — | | — | | 4,010 | ||||||||
| Non-controlling interest in partner companies | | — | | — | — | | — | | (12,363) | | — | | 12,363 | | | — | ||||||
| Net loss attributable to non-controlling interest | | — | | — | — | | — | | — | | — | | (17,876) | | | (17,876) | ||||||
| Net loss attributable to common stockholders | — | | — | — | | — | | — | | (10,948) | | — | | (10,948) | ||||||||
| Balance as of June 30, 2024 | 3,427,138 | $3 | 22,587,038 | $23 | $739,086 | $(721,235) | $(32,475) | $(14,598) | ||||||||||||||
For the Three Months Ended June 30, 2023
| | | | | | | | | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Series A Perpetual · · · · · · · Common · · · · · · · · · · Total | |||||||||||||||||||||||||
| · · Preferred Stock · · Common Stock · · Shares · · Paid-In · · Accumulated · · Non-Controlling · · Stockholders’ | |||||||||||||||||||||||||
| · Shares · Amount · Shares · Amount · Issuable · Capital · Deficit · Interests · Equity | |||||||||||||||||||||||||
| Balance as of March 31, 2023 | 3,427,138 | $3 | 8,694,477 | $9 | | $— | | $693,554 | $(655,770) | | $(17,990) | $19,806 | |||||||||||||
| Stock-based compensation expense | — | | — | — | | — | | — | | 4,217 | | — | | — | | 4,217 | |||||||||
| Issuance of common stock related to equity plans | — | | — | 5,515 | | — | | — | | — | | — | | — | | — | |||||||||
| Issuance of common stock for public offering, net | — | | — | — | | — | | — | | (41) | | — | | — | | (41) | |||||||||
| Issuance of common stock for at-the-market offering, net | | — | | | — | | 66,098 | | — | | | — | | | 721 | | — | | | — | | | 721 | ||
| Common shares issued for dividend on partner company's convertible preferred shares | | — | | | — | | 11,066 | | | — | | | 23 | | | 108 | | | — | | | — | | | 131 |
| Preferred A dividends declared and paid | — | | — | — | | — | | — | | (2,008) | | — | | — | | (2,008) | |||||||||
| Partner company’s offering, net | — | | — | — | | — | | — | | 14,460 | | — | | — | | 14,460 | |||||||||
| Issuance of common stock under partner company’s ESPP | | — | | — | — | | — | | — | | 88 | | — | | — | | | 88 | |||||||
| Partner company’s dividends declared and paid | — | | — | — | | — | | — | | (185) | | — | | — | | (185) | |||||||||
| Issuance of partner company’s common shares for research and development expenses | — | | — | — | | — | | — | | 3 | | — | | — | | 3 | |||||||||
| Partner company’s exercise of options for cash | — | | — | — | | — | | — | | 3 | | — | | — | | 3 | |||||||||
| Partner company’s warrants issued in conjunction with debt | — | | — | — | | — | | — | | 272 | | — | | — | | 272 | |||||||||
| Deconsolidation of Aevitas non-controlling interest | | | | | | | | | | | | | | | | | | | | | | 5,891 | | | 5,891 |
| Non-controlling interest in partner companies | | — | | — | — | | — | | — | | (12,172) | | — | | 12,172 | | | — | |||||||
| Net loss attributable to non-controlling interest | | — | | — | — | | — | | — | | — | | — | | (34,525) | | | (34,525) | |||||||
| Net loss attributable to common stockholders | — | | — | — | | — | | — | | — | | (24,776) | | — | | (24,776) | |||||||||
| Balance as of June 30, 2023 | | 3,427,138 | $3 | 8,777,156 | $9 | | $23 | | $699,020 | $(680,546) | | $(34,452) | $(15,943) | ||||||||||||
For the Six Months Ended June 30, 2024
| | | | | | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Series A · · · · · · · · · · · · · 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 | — | | — | — | | — | | | 9,856 | | — | | — | | 9,856 | |||||||
| Issuance of common stock related to equity plans | — | | — | 495,761 | | — | | | — | | — | | — | | — | |||||||
| Issuance of common stock under ESPP | | — | | — | 29,844 | | — | | | 51 | | — | | — | | 51 | ||||||
| Issuance of common stock for public offering, net | | — | | — | 3,303,305 | | 3 | | | 10,115 | | — | | — | | 10,118 | ||||||
| Issuance of common stock for at-the-market offering, net | | — | | | — | | 1,554,483 | | | 2 | | | 2,824 | | | — | | | — | | | 2,826 |
| Common shares issued for dividend on partner company's convertible preferred shares | — | | — | 64,747 | | — | | 114 | | — | | — | | 114 | ||||||||
| Common shares issued for exchange of partner company's convertible preferred shares | — | | — | 2,028,345 | | 3 | | 3,406 | | — | | — | | 3,409 | ||||||||
| Warrants issued in conjunction with exchange of partner company's convertible preferred shares | | | | | | | | | | | | | 341 | | | | | | | | | 341 |
| Preferred A dividends declared and paid | — | | — | — | | — | | | (4,016) | | — | | — | | (4,016) | |||||||
| Partner companies' offerings, net | — | | — | — | | — | | | 18,002 | | — | | — | | 18,002 | |||||||
| Partner companies' at-the-market offering, net | — | | — | — | | — | | | 1,779 | | — | | — | | 1,779 | |||||||
| Issuance of common stock under partner company’s ESPP | — | | — | — | | — | | | 133 | | — | | | — | | 133 | ||||||
| Partner company’s dividends declared and paid | — | | — | — | | — | | | (352) | | — | | — | | (352) | |||||||
| Exercise of warrants for cash | — | | — | 17,500 | | — | | 30 | | — | | — | | 30 | ||||||||
| Exercise of partner company options and warrants for cash, net | | — | | | — | | — | | | — | | | 9,370 | | | — | | | — | | | 9,370 |
| Non-controlling interest in partner companies | | — | | | — | | — | | | — | | | (29,963) | | | — | | | 29,963 | | | — |
| Net loss attributable to non-controlling interest | | — | | | — | | — | | | — | | | — | | | — | | | (41,481) | | | (41,481) |
| Net loss attributable to common stockholders | | — | | | — | | — | | | — | | | — | | | (26,365) | | | — | | | (26,365) |
| Balance as of June 30, 2024 | 3,427,138 | | $3 | 22,587,038 | | $23 | | $739,086 | | $(721,235) | | $(32,475) | | $(14,598) | ||||||||
Unaudited Condensed Consolidated Statement of Changes in Stockholders’ Equity
For the Six Months Ended June 30, 2023
| | | | | | | | | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Series A · · · · · · · Common · · · · · Additional · · · · · Total | |||||||||||||||||||||||||
| · · Preferred Stock · · Common Stock · · Shares · · Paid-In · · Accumulated · · Non-Controlling · · Stockholders’ | |||||||||||||||||||||||||
| · · Shares · · Amount · · Shares · · Amount · · Issuable · · 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 | — | | — | — | | — | | — | | | 8,948 | | — | | — | | 8,948 | ||||||||
| Issuance of common stock related to equity plans | — | | — | 183,856 | | — | | | — | | | — | | — | | — | | — | |||||||
| Issuance of common stock for public offering, net | | — | | — | 1,109,526 | | 2 | | | — | | | 13,152 | | — | | — | | 13,154 | ||||||
| Issuance of common stock for at-the-market offering, net | | — | | — | 106,425 | | — | | | — | | | 1,168 | | — | | — | | 1,168 | ||||||
| Common shares issued for dividend on partner company's convertible preferred shares | | — | | — | 11,066 | | — | | | 23 | | | 108 | | — | | — | | 131 | ||||||
| Preferred A dividends declared and paid | | — | | — | — | | — | | | — | | | (4,016) | | — | | — | | (4,016) | ||||||
| Partner company’s offering, net | | — | | — | — | | — | | | — | | | 21,977 | | — | | — | | 21,977 | ||||||
| Partner company’s exercise of options for cash | | — | | — | — | | — | | | — | | | 3 | | — | | — | | 3 | ||||||
| Issuance of common stock under partner company’s ESPP | | — | | — | — | | — | | | — | | | 88 | | — | | — | | 88 | ||||||
| Partner company’s dividends declared and paid | | — | | | — | | — | | | — | | | — | | | (371) | | | — | | | — | | | (371) |
| Issuance of partner company’s common shares for research and development expenses | — | | — | — | | — | | | — | | | 1,233 | | — | | — | | 1,233 | |||||||
| Warrants | | — | | — | | — | | — | | | — | | | 272 | | | — | | — | | 272 | ||||
| Deconsolidation of Aevitas non-controlling interest | | — | | — | | — | | — | | | — | | | — | | | — | | 5,891 | | 5,891 | ||||
| Non-controlling interest in partner companies | — | | — | — | | — | | | — | | | (19,486) | | — | | | 19,486 | | — | ||||||
| Net loss attributable to non-controlling interest | — | | — | — | | — | | | — | | — | | — | | (68,133) | | (68,133) | ||||||||
| Net loss attributable to common stockholders | | — | | | — | | — | | | — | | | — | | | — | | | (46,313) | | | — | | | (46,313) |
| Balance as of June 30, 2023 | 3,427,138 | | $3 | 8,777,156 | | $9 | | $23 | | $699,020 | | $(680,546) | | $(34,452) | | $(15,943) | |||||||||
Unaudited Condensed Consolidated Statements of Cash Flows
($ in thousands)
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Six Months Ended June 30, | ||||||
| · 2024 · 2023 | ||||||
| Cash Flows from Operating Activities: · · | ||||||
| Net loss | | $(67,846) | | $(114,446) | ||
| Reconciliation of net loss to net cash used in operating activities: | | | | |||
| Depreciation expense | | 753 | | 1,476 | ||
| Loss on disposal of property and equipment | | | 29 | | | — |
| Bad debt expense | | | 152 | | 574 | |
| Amortization of debt discount | | 1,365 | | 1,867 | ||
| Accretion of partner company convertible preferred shares | | (737) | | 521 | ||
| Non-cash interest | | | — | | | 176 |
| Loss on extinguishment of debt | | — | | 2,796 | ||
| Amortization of acquired intangible assets | | 1,629 | | 2,138 | ||
| Reduction in the carrying amount of operating lease right-of-use assets | | 1,893 | | 1,052 | ||
| Stock-based compensation expense | | 9,856 | | 8,948 | ||
| Issuance of partner company’s common shares for research and development expenses | | — | | 1,233 | ||
| Expense (income) associated with partner company warrant liabilities | | 445 | | (6,166) | ||
| Common shares issued for dividend on partner company's convertible preferred shares | | | 114 | | | 131 |
| Research and development - licenses acquired, expense | | — | | 3,000 | ||
| Loss from deconsolidation/dissolution of subsidiaries | | | — | | | 3,369 |
| Asset impairment loss | | | 2,649 | | | 2,923 |
| Increase (decrease) in cash and cash equivalents resulting from changes in operating assets and liabilities: | | | | |||
| Accounts receivable | | 4,605 | | 10,897 | ||
| Inventory | | 519 | | 1,993 | ||
| Other receivables - related party | | (57) | | (135) | ||
| Prepaid expenses and other current assets | | 1,837 | | 2,243 | ||
| Other assets | | 927 | | (97) | ||
| Accounts payable and accrued expenses | | (2,837) | | 433 | ||
| Deferred revenue | | | — | | | (364) |
| Income taxes payable | | | (37) | | | 1 |
| Lease liabilities | | (2,390) | | (980) | ||
| Other long-term liabilities | | (94) | | (94) | ||
| Net cash used in operating activities | | (47,225) | | (76,511) | ||
| | | | | | | |
| Cash Flows from Investing Activities: | | | ||||
| Purchase of research and development licenses | | — | | (2,000) | ||
| Purchase of property and equipment | | — | | (34) | ||
| Other | | | — | | | (5) |
| Acquisition of VYNE products | | | — | | | (5,000) |
| Net cash used in investing activities | | — | | (7,039) | ||
Unaudited Condensed Consolidated Statements of Cash Flows
($ in thousands)
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Six Months Ended June 30, | ||||||
| · · 2024 · · 2023 | ||||||
| Cash Flows from Financing Activities: · · | ||||||
| Payment of Series A perpetual preferred stock dividends | $(4,016) | $(4,016) | ||||
| Proceeds from issuance of common stock for public offering, net | | | 10,118 | | | 13,248 |
| Proceeds from issuance of common stock for at-the-market offering, net | | | 2,826 | | | 1,168 |
| Proceeds from issuance of common stock under ESPP | | | 51 | | | — |
| Exercise of warrants for cash | | | 30 | | | — |
| Proceeds from partner companies' ESPP | | | 133 | | 88 | |
| Partner company’s dividends declared and paid | | | (352) | | (371) | |
| Proceeds from partner companies' sale of stock, options and warrants, net | | | 26,214 | | | 24,455 |
| Proceeds from partner companies' at-the-market offering, net | | 1,779 | | — | ||
| Proceeds from exercise of partner companies’ equity grants | | | — | | | 3 |
| Proceeds from partner company convertible preferred shares | | | — | | | 854 |
| Stock and warrants issued for exchange of partner company preferred shares | | | 341 | | | — |
| Payment of debt issuance costs associated with partner company convertible preferred shares | | | — | | | (210) |
| Proceeds from partner company's long-term debt, net | | | 5,000 | | | (90) |
| Repayment of partner companies' long-term debt | | | — | | | (40,375) |
| Proceeds from partner company's line of credit | | | — | | | 28,000 |
| Repayment of partner company's line of credit | | | — | | | (30,948) |
| Net cash (used in) provided by financing activities | | 42,124 | | (8,194) | ||
| Net increase (decrease) in cash and cash equivalents and restricted cash | | (5,101) | | (91,744) | ||
| 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 | | $78,264 | | $89,210 | ||
| | | | | | | |
| Supplemental disclosure of cash flow information: | | | | | ||
| Cash paid for interest | | $3,536 | | $5,131 | ||
| Cash paid (refunded) for income taxes | | $115 | | $(52) | ||
| | | | | | | |
| Supplemental disclosure of non-cash financing and investing activities: | | | ||||
| Exchange of partner company convertible preferred shares for common shares | | $3,408 | | $— | ||
| Fair value of assets received by partner company in repurchase transaction | | $2,209 | | | — | |
| Fair value of supplies received by partner company expensed to research and development | | $2,509 | | | — | |
| Partner company accounts receivable write-off related to repurchase transaction | | $(6,967) | | | — | |
| Partner company accounts payable write-off related to repurchase transaction | | $3,644 | | | — | |
| Partner company's net purchase consideration of assets recorded to accrued other | | $(1,395) | | | — | |
| Transfer of assets classified as held for sale | | $— | | $4,348 | ||
| Settlement of restricted stock units into common stock | | $— | | $3 | ||
| Unpaid partner company’s offering cost | | $— | | $246 | ||
| Partner company derivative warrant liability associated with partner company convertible preferred shares | | $— | | $33 | ||
| Prepaid public offering cost | | $— | | $94 | ||
| | | | | | | |
- 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”) and Oncogenuity, Inc. (“Oncogenuity”).
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 $38.2 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 8 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 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.
Restricted Cash
The Company records cash held in trust or pledged to secure certain debt obligations as restricted cash. As of June 30, 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:
| · · · · · · | ||||
|---|---|---|---|---|
| · · June 30, | ||||
| | | 2024 | | 2023 |
| Cash and cash equivalents | $76,201 | $78,022 | ||
| Restricted cash | | 2,063 | | 11,188 |
| Total cash and cash equivalents and restricted cash | | $78,264 | | $89,210 |
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 other than the following:
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 June 30, 2024, there are $2.2 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).
Recently Issued Accounting Pronouncements
Accounting Standards Not 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 statement 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 statement disclosures.
- Asset Purchase Agreements
Mustang
Agreements with 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. As of June 30, 2024, the $1.4 million Purchase Price 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.
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 net proceeds of future financings, until $4.0 million in the aggregate is paid to InvaGen. In connection with equity financings in the first half of 2024, Avenue made payments totaling $0.6 million to InvaGen.
4. Inventory
| | | | | | |
|---|---|---|---|---|---|
| · June 30, · · December 31, | |||||
| ($ in thousands) · 2024 · · 2023 | |||||
| Raw materials | $3,583 | | $4,640 | ||
| Work-in-process | 296 | | 884 | ||
| Finished goods | 6,213 | | 4,987 | ||
| Inventory reserve | | (405) | | | (305) |
| Total inventories | $9,687 | | $10,206 | ||
- Property and Equipment
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · Useful Life · June 30, · · December 31, | |||||||||
| ($ 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 | | | | | | (2,177) | | | — |
| Less: Accumulated depreciation | | | | | (9,645) | | (8,892) | ||
| Property and equipment, net | | | | | $3,546 | | $6,505 | ||
Fortress' depreciation expense for the three months ended June 30, 2024 and 2023 was approximately $0.4 million and $0.8 million, respectively, and for the six months ended June 30, 2024 and 2023 was approximately $0.8 million and $1.5 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.
Impairment of Long-Lived Assets
During the three months ended June 30, 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 $0.4 million allocated to the right-of-use asset.
- Fair Value Measurements
Common Stock Warrant Liabilities
| | | | |
|---|---|---|---|
| · · Warrants | |||
| ($ in thousands) | liabilities | ||
| Balance at December 31, 2023 | | $886 | |
| Change in fair value of common stock warrants - Avenue | | | (139) |
| 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 | | | (400) |
| Exchange of common stock warrants - Urica | | | (151) |
| Balance at June 30, 2024 | | $172 | |
Checkpoint
Checkpoint deemed the placement agent warrants it issued in connection with its registered direct offering (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 June 30, 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:
| | | | | | | | | |
|---|---|---|---|---|---|---|---|---|
| · · June 30, · · December 31, · · | ||||||||
| Checkpoint Warrants · · 2024 · · 2023 · · | ||||||||
| Exercise price | | $5.41 | | $5.41 | | | ||
| Volatility | | | 106.9% | | 96.4% | | ||
| Expected life in years | | | 3.5 | | | 4.0 | | |
| Risk-free rate | | | 4.5% | | 3.8% | | ||
Avenue
Certain of Avenue’s outstanding warrants to purchase shares of its common stock are classified as liabilities on the balance sheet as they contain terms for redemption of the underlying security that are outside of its control. The Black-Scholes model was used to value these Avenue warrants, at the time of issuance and when re-measured at each financial reporting date, up to exercise or expiration of the warrants, with any changes in fair value being recognized in change in fair value of warrant liabilities, a component of other income (expense) in the unaudited condensed consolidated statements of operations.
| | | | |
|---|---|---|---|
| · · Avenue | |||
| · · Warrant | |||
| ($ in thousands) · · Liability | |||
| 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 | | | (139) |
| Avenue common stock warrant liabilities at June 30, 2024 | | $47 | |
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:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| | | June 30, | | | December 31 | | |
| | | 2024 | | | 2023 | | |
| Stock price | | $ 3.50 | | | $ 12.00 | | |
| Risk-free interest rate | 4.52% | | 3.84% | | |||
| Expected dividend yield | — | | — | | |||
| Expected term in years | 3.3 | | 3.8 | | |||
| Expected volatility | 160% | | 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:
| · · · | |
|---|---|
| · · December 31, | |
| · · 2023 | |
| Risk-free interest rate | 3.93% |
| Expected dividend yield | — |
| Expected term in years | 0.5 |
| Expected volatility | 153.6% |
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 $1.68. The Fortress common stock warrants have afive-year life, expiring on June 27, 2029.
- Intangible Assets, net
The Company’s finite-lived intangible assets consist of intangible assets acquired by Journey. The table below provides a summary of the Journey intangible assets for the periods presented:
| | | | | | | | | |
|---|---|---|---|---|---|---|---|---|
| · · Estimated Useful · · June 30, · · December 31, | ||||||||
| ($ in thousands) · Lives (Years) · 2024 · 2023 | ||||||||
| · · · · · · · | ||||||||
| Intangible assets – product licenses | | 3 to 9 | | $37,925 | | $37,925 | ||
| Accumulated amortization | | (16,124) | | (14,495) | ||||
| Accumulated Impairment loss | | | | | (3,143) | | | (3,143) |
| Net intangible assets | | $18,658 | | $20,287 | ||||
For the three months ended June 30, 2024 and 2023, Journey’s amortization expense related to its product licenses was $0.8 million and $1.1 million, respectively. For the six months ended June 30, 2024 and 2023, Journey’s amortization expense related to its product licenses was $1.6 million and $2.1 million, respectively. Journey records amortization expense related to its product licenses as a component of cost of goods sold on the unaudited condensed consolidated statement of operations.
The future amortization of these intangible assets is as follows:
| | | | |
|---|---|---|---|
| · · Total | |||
| ($ in thousands) | Amortization | ||
| Remainder of 2024 | | $1,628 | |
| 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 | | $14,716 | |
| Asset not yet placed in service | | | 3,942 |
| Total | | $18,658 | |
- License Agreements
In accordance with ASC 730-10-25-1, Research and Development, costs incurred in obtaining technology licenses are charged to research and development expense if the technology licensed has not reached technological feasibility and has no alternative future use. The licenses purchased by Fortress and its subsidiaries and partner companies require substantial completion of research and development, and regulatory and marketing approval efforts, in order to reach technological feasibility. As such, the purchase price of any licenses acquired is classified as research and development-licenses acquired in the unaudited condensed consolidated statement of operations.
- Debt and Interest
Debt
Total debt consists of the following:
| | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|
| · June 30, · · December 31, · · | ||||||||||
| ($ in thousands) · · 2024 · · 2023 · · Interest rate · · Maturity | ||||||||||
| · · · · · · · · · | ||||||||||
| Oaktree Note | | $50,000 | | $50,000 | 11.0% | August - 2025 | ||||
| SWK Term Loan | | | 20,000 | | | 15,000 | | 14.9% | December - 2027 | |
| Less: Discount on notes payable | | | (2,993) | | | (4,144) | | | | |
| Total notes payable | | $67,007 | | $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 “Prior Oaktree Agreement” and the debt thereunder, the “Oaktree Note”). 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 in compliance with all applicable covenants under the Prior Oaktree Agreement as of June 30, 2024.
The Company was required to make quarterly interest-only payments until the fifth anniversary of the closing date of the Oaktree Note, August 27, 2025, at which point the outstanding principal amount would have been due. The Company could have voluntarily prepaid the Oaktree Note at any time subject to a prepayment fee. The Company was required to make mandatory prepayments of the Oaktree Note under various circumstances as defined in the Prior Oaktree Agreement. No mandatory prepayments were required in the six months ended June 30, 2024.
On July 25, 2024, Fortress entered into a $50.0 million senior secured credit agreement with a maturity date of July 25, 2027 (the “Agreement”) with Oaktree. The Company borrowed $35.0 million under the Agreement on the Closing Date and is eligible to draw up to an additional $15.0 million at the lenders’ discretion to support future business development activities. The Agreement replaces the Prior Oaktree Agreement in which the remaining $50.0 million balance was repaid in full (see Note 19).
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. 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 thethree-month term SOFR (subject to a SOFR floor of 5%)plus 7.75%. The interest rate resets quarterly. Interest payments began in February 2024 and are paid quarterly.
On July 9, 2024, Journey entered into an amendment (the “SWK Amendment”) to the Credit Facility. The SWK Amendment increased the total amount available under the Credit Facility from $20.0 million to $25.0 million. The $5.0 million available under the SWK Amendment is contractually required to be drawn upon FDA approval of Journey’s DFD-29 product candidate, subject to Journey receiving such approval on or before June 30, 2025 (See Note 19).
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 June 30, 2024 was 14.9%.
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 June 30, 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).
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 closing price over the 10-day period preceding the dividend payment date. Dividends were recorded as interest expense. For the three month periods ended June 30, 2024 and 2023, the Company recorded expense of $0.1 million and $0.1 million associated with the Urica dividends and for the six month periods ended June 30, 2024 and 2023, the Company recorded expense of $0.1 million and $0.1 million associated with the Urica dividends.
The shares mandatorily converted into Urica common stock upon either: (i) a qualified financing pursuant to which Urica raises at least $20 million in aggregate gross proceeds; or (ii) a sale of Urica. Additionally, in the event that neither such a qualified financing nor a sale of Urica had occurred prior to June 27, 2024, then each holder of Urica Preferred Stock was eligible to receive, at Fortress’ election, one of: (x) a cash payment equal to the product of the Subscription Price and the number of shares of Urica Preferred Stock held by such holder; (y) a number of shares of Fortress common stock equal to the Fortress Share Exchange Amount; or (z) a combination of the foregoing. On June 27, 2024, as neither a qualified financing nor a sale of Urica occurred, Fortress elected to exchange the outstanding shares of Urica Preferred Stock, which was recorded as a liability, into 2,028,345 shares of Fortress common stock.
Interest Expense
Interest expense includes contractual interest, and fees include amortization of the debt discount and amortization of fees associated with loan transaction costs, amortized over the life of the loan. The following table shows the components of interest expense for all debt arrangements during the periods presented:
| | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended June 30, | ||||||||||||||||||
| · · 2024 · · 2023 | ||||||||||||||||||
| ($ in thousands) · Interest · Fees · Total · Interest · Fees · Total | ||||||||||||||||||
| Oaktree Note | | | 1,390 | | | 522 | | | 1,912 | | | 1,391 | | | 712 | | | 2,103 |
| Partner company convertible preferred shares | | | (403) | | | 45 | | | (358) | | | 391 | | | 239 | | | 630 |
| Partner company installment payments - licenses | | | — | | | — | | | — | | | 85 | | | — | | | 85 |
| Partner company notes payable | | | 499 | | | 64 | | | 563 | | | 3,301 | | | 272 | | | 3,573 |
| Other | | 5 | | — | | 5 | | 34 | | | — | | | 34 | ||||
| Total Interest Expense and Financing Fee | | $1,491 | | $631 | | $2,122 | | $5,202 | | $1,223 | | $6,425 | ||||||
| | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Six Months Ended June 30, | ||||||||||||||||||
| · · 2024 · · 2023 | ||||||||||||||||||
| ($ in thousands) · Interest · Fees · Total · Interest · Fees · Total | ||||||||||||||||||
| Oaktree Note | | | 2,781 | | | 1,024 | | | 3,805 | | | 2,781 | | | 1,136 | | | 3,917 |
| Partner company convertible preferred shares | | | (290) | | | 90 | | | (200) | | | 651 | | | 299 | | | 950 |
| Partner company installment payments - licenses | | | — | | | — | | | — | | | 176 | | | — | | | 176 |
| Partner company notes payable | | | 985 | | | 126 | | | 1,111 | | | 4,801 | | | 432 | | | 5,233 |
| Other | | 8 | | — | | 8 | | 113 | | 332 | | | 445 | |||||
| Total Interest Expense and Financing Fee | | $3,484 | | $1,240 | | $4,724 | | $8,522 | | $2,199 | | $10,721 | ||||||
- Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses consisted of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · June 30, · · December 31, | ||||||
| ($ in thousands) · 2024 · 2023 | ||||||
| · · · · · | ||||||
| Accounts payable | | $37,957 | | $34,810 | ||
| Accrued expenses: | | | ||||
| Professional fees | | | 2,260 | | | 1,681 |
| Salaries, bonus and related benefits | | 4,903 | | 8,531 | ||
| Research and development | | 8,547 | | 11,644 | ||
| Accrued royalties payable | | 1,656 | | 2,015 | ||
| Accrued coupon and rebates | | 6,596 | | 9,987 | ||
| Return reserve | | | 3,214 | | | 4,077 |
| Other1 | | 3,788 | | 817 | ||
| Total accounts payable and accrued expenses | | $68,921 | | $73,562 | ||
Note 1: Includes approximately $1.4 million of accrued consideration related to Mustang’s Asset Purchase Agreement with uBriGene (see Note 3) as of June 30, 2024.
- Non-Controlling Interests
The Company’s ownership interests in its consolidated subsidiaries at June 30, 2024 was similar to December 31, 2023, except for Mustang which decreased from 19% to 7.2%.
- 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 and six months ended June 30, 2024, the effect on the net loss per share calculation from Series A Preferred dividends was $2.0 million and $4.0 million, respectively, and partner company deemed dividends were $0.4 million and $0.8 million, respectively. For the three and six months ended June 30, 2023, the effect on the net loss per share calculation from Series A Preferred dividends was $2.0 million and $4.0 million, respectively, and partner company deemed dividends were $0.1 million and $0.3 million, respectively.
The following shares of potentially dilutive securities, weighted during the six months ended June 30, 2024 and 2023, have been excluded from the computation of diluted weighted average shares outstanding, as the effect of including such securities would be anti-dilutive:
| · · · · | ||
|---|---|---|
| | | |
| | | Six Months Ended June 30, |
| · · 2024 · 2023 | ||
| Warrants to purchase Common Stock | 5,769,787 | 127,296 |
| Options to purchase Common Stock | 18,896 | 36,423 |
| Unvested Restricted Stock | 1,693,684 | 1,374,116 |
| Unvested Restricted Stock Units | 273 | 73 |
| Total | 7,482,640 | 1,537,908 |
- Stockholders’ Equity
Stock-based Compensation
As of June 30, 2024, the Company had the following equity compensation plans: the Fortress Biotech, Inc. 2013 Stock Incentive Plan, as amended (the “2013 Plan”), the Fortress Biotech, Inc. 2012 Employee Stock Purchase Plan (the “ESPP”) and the Fortress Biotech, Inc. Long Term Incentive Plan (“LTIP”). In May 2024, the Company’s Board of Directors and stockholders approved an amendment to the 2013 Plan to increase the number of authorized shares issuable by 10.0 million shares, and approved an amendment to the ESPP to increase the number of shares issuable by 1.0 million. As of June 30, 2024, approximately 10.0 million shares were available for issuance under the 2013 Plan.
The following table summarizes the stock-based compensation expense from stock option, employee stock purchase programs and restricted Common Stock awards and warrants for the periods presented:
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended June 30, · · Six Months Ended June 30, | ||||||||||||
| ($ in thousands) · 2024 · 2023 · · 2024 · 2023 | ||||||||||||
| Fortress: | | | | | | | | | | | | |
| Employee and non-employee awards | | $2,249 | | $2,271 | | $4,442 | | $4,708 | ||||
| Executive awards | | 273 | | 410 | | 497 | | 817 | ||||
| | | | | | | | | | | | | |
| Partner Companies: | | | | | | | | | | | | |
| Avenue | | 192 | | 27 | | 383 | | 38 | ||||
| Checkpoint | | 1,171 | | 567 | | 1,881 | | 1,536 | ||||
| Mustang | | (619) | | 45 | | (542) | | 280 | ||||
| Journey | | | 1,674 | | | 873 | | | 3,080 | | | 1,519 |
| Other | | 58 | | 24 | | 115 | | 50 | ||||
| Total stock-based compensation expense | | $4,998 | | $4,217 | | $9,856 | | $8,948 | ||||
For the three months ended June 30, 2024 and 2023, approximately $0.7 million and $0.5 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 $4.3 million and $3.7 million, respectively, was included in general and administrative expenses in connection with grants made to employees, members of the board of directors and consultants.
For the six months ended June 30, 2024 and 2023, approximately $1.7 million and $1.5 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 $8.1 million and $7.5 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 | | | 16,200 | | 6.71 |
| Options vested and expected to vest at June 30, 2024 | 558,896 | | $2.32 | | $16,200 | 6.52 | ||||
| Options vested and exercisable at June 30, 2024 | | 18,896 | | $20.55 | | $— | 1.26 | |||
As of June 30, 2024 and 2023, Fortress had $0.6 million and $0.6 million, respectively, in unrecognized stock-based compensation expense related to options which is expected to be recognized over the remaining weighted-average vesting period of 3.6 years and 5.7 years, respectively.
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 | | 443,024 | | | 3.01 |
| Restricted stock vested | | (17,303) | | | 35.76 |
| Restricted stock units granted | | 37,500 | | | 1.84 |
| Restricted stock units forfeited | | (10,582) | | | 11.43 |
| Restricted stock units vested | | (49,684) | | | 39.61 |
| Unvested balance at June 30, 2024 | | 1,861,655 | | $21.27 | |
As of June 30, 2024 and 2023, the Company had unrecognized stock-based compensation expense related to restricted stock and restricted stock unit awards of approximately $11.5 million and $16.0 million, respectively, which is expected to be recognized over the remaining weighted-average vesting period of 1.3 years and 2.0 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 | 5,787,289 | | $1.88 | | $7,794,450 | 4.91 | ||||
| Issued | | 3,506,140 | | | 3.12 | | | 8,113 | | — |
| Exercised | | (17,500) | | | 1.70 | | | — | | — |
| Outstanding as of June 30, 2024 | 9,275,929 | | $2.35 | | $64,538 | 4.46 | ||||
| Exercisable as of June 30, 2024 | 9,275,929 | | $2.35 | | $64,538 | 4.46 | ||||
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 and May 23, 2024). 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’ original vesting terms includes vesting in full if the employee was 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 an involuntary Separation from Service (as defined in the LTIP). The only other vesting condition – one based on the 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 June 30, 2024 and 2023, the Company recorded stock compensation expense related to LTIP grants of approximately $1.7 million and $1.5 million, respectively, and for the six months ended June 30, 2024 and 2023, the Company recorded stock compensation expense related to LTIP grants of approximately $3.3 million and $2.9 million, 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 $86.2 million of securities were available for sale under the 2021 Shelf as of June 30, 2024, subject to General Instruction I.B.6. of Form S-3. 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”). All $50.0 million of securities were available for sale under the 2024 Shelf as of June 30, 2024, subject to General Instruction I.B.6. of Form S-3.
At the Market Offering
During the six months ended June 30, 2024, the Company issued and sold approximately 1.6 million shares at an average price of $1.87 per share for gross proceeds of $2.9 million. During the six months ended June 30, 2023, the Company issued and sold approximately 0.1 million shares at an average price of $11.31 for gross proceeds of $1.2 million.
Registered Direct Offering
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 $10.2 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 June 30, 2024, approximately $77.7 million of the securities remains available for sale through the Checkpoint 2023 S-3, subject to General Instruction I.B.6 of Form 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 $12.6 million after deducting commissions and other transaction costs. As of July 2024, all of the pre-funded warrants from the Checkpoint January 2024 Registered Direct Offering were fully exercised (see Note 19).
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 for the six months ended June 30, 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 June 30, 2024, approximately $24.6 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.
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 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).
Also in April 2024, Avenue entered into definitive agreements for the immediate exercise of certain of its existing outstanding warrants 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 in the May 2024 Warrant Inducement, 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 have an exercise price of $6.20 per share, and terms ofeighteen months for one series andfive years for the other series. Total net proceeds to Avenue were approximately $3.7 million after deducting placement agent fees and other expenses payable by Avenue.
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 2021 Avenue S-3, and the related prospectus supplement dated May 10, 2024. During the six months ended June 30, 2024, Avenue issued 87,683 shares through the Avenue ATM for net proceeds of $0.3 million.
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 exercises noted above. Accordingly, Avenue issued 25,567 shares of common stock to Fortress for the six-month period ended June 30, 2024.
Mustang 2021 Shelf Registration Statement and At-the-Market Offering (the “Mustang ATM”)
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. Under the Mustang 2021 S-3, Mustang was able to sell up to a total of $200.0 million of its securities. In the six months ended June 30, 2024, Mustang sold approximately $4.4 million of securities under the Mustang 2021 S-3 until its expiration 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 June 30, 2024, approximately $37.5 million of the Mustang 2024 S-3 remains available for sales of securities, subject to General Instruction I.B.6. of Form S-3.
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 six months ended June 30, 2024, Mustang issuedno shares through the Mustang ATM.
Mustang Public Offering
In May 2024, Mustang closed on a public offering of 1,160,000 shares of common stock and pre-funded warrants to purchase up to 15,717,638 shares of common stock (or common stock equivalents in lieu thereof), and three series of 16,877,638 warrants each for a total of 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. 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 public offering, after deducting the fees and expenses of the placement agent and other offering expenses payable by Mustang was approximately $3.3 million. All of the 15,717,638 pre-funded warrants were exercised as of June 30, 2024.
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.
Mustang Registered Direct Offering
In June 2024, Mustang closed on a registered direct offering of 3,025,000 shares of common stock at $0.41 per share (or common stock equivalent) priced at-the-market under Nasdaq rules and pre-funded warrants to purchase up to 3,105,000 shares of common stock, at a price per pre-funded warrant equal to $0.4099, the price per share of common stock, less $0.001. The pre-funded warrants have an exercise price of $0.001 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 6,130,000 shares of its common stock, with an exercise price of $0.41 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 $2.2 million, after placement agent’s fees and other offering expenses of approximately $0.3 million. All of the 3,105,000 pre-funded warrants were exercised as of June 30, 2024.
Pursuant to the Company’s Founders Agreement with Mustang, Mustang issued to Fortress 2.5% of the aggregate number of shares of common stock issued in the financings noted above. Accordingly, Mustang issued 575,191 shares of common stock to Fortress for the six-month period ended June 30, 2024.
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 six months ended June 30, 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 $1.5 million under the Journey ATM Sales Agreement. At June 30, 2024,3,861,553 shares remain available for issuance under the Journey ATM Sales Agreement.
- Commitments and Contingencies
Leases
At June 30, 2024, Mustang identified triggering events that required an impairment of the asset group consisting of its’ right-of-use asset and associated leasehold improvements. The assessment concluded that impairment existed as of June 30, 2024, and the impairment loss was allocated to the leasehold improvements and right-of-use assets based on the relative carrying amounts of the assets (see Note 3).
During three and six months ended June 30, 2024 and 2023, the Company recorded the following as lease costs for the periods presented:
| · · · · · · · · · · · · · | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| · Three Months Ended June 30, · Six Months Ended June 30, | |||||||||||
| ($ in thousands) · · 2024 · · 2023 · · 2024 · · 2023 · | |||||||||||
| Operating lease cost | | $595 | | $950 | | $1,235 | | $1,969 | | ||
| Shared lease costs | | (519) | | | (519) | | (1,042) | | | (1,034) | |
| Variable lease cost | | 174 | | | 199 | | 390 | | | 400 | |
| Total lease expense | | $250 | | $630 | | $583 | | $1,335 | | ||
The following tables summarize quantitative information about the Company’s operating leases, under the adoption of ASC Topic 842*, Leases*:
| · · · · · · · · | ||||||
|---|---|---|---|---|---|---|
| | Six Months Ended June 30, | |||||
| ($ in thousands) · · 2024 · · 2023 · | ||||||
| Operating cash flows from operating leases | | $(1,850) | | $(1,762) | | |
| Right-of-use assets exchanged for new operating lease liabilities | | $— | | $— | | |
| Weighted-average remaining lease term – operating leases (years) | | 4.0 | | 4.4 | | |
| Weighted-average discount rate – operating leases | | 6.0% | 6.5% | | ||
| | | | |
|---|---|---|---|
| | Future Lease | ||
| ($ in thousands) · · Liability | |||
| Nine Months Ended December 31, 2024 | | $1,819 | |
| Year Ended December 31, 2025 | | 3,542 | |
| 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 | | 22,648 | |
| Less: present value discount | | (4,233) | |
| Net operating lease liabilities, short-term and long-term | | $18,415 | |
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). A jury trial is scheduled for September 2024 in Knoxville, TN.
- 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 June 30, 2024 and 2023 the Company invoiced TGTX$0.1 million and$0.1 million, respectively; for the six months ended June 30, 2024 and 2023 invoiced TGTX$0.7 million and$0.2 million, respectively. At June 30, 2024, approximately$0.1 million 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 June 30, 2024 and 2023, the Company’s employees have provided services to Journey totaling approximately $8,000 and $21,000, respectively. For the six months ended June 30, 2024 and 2023, the Company’s employees have provided services to Journey totaling approximately $18,000 and $36,000, respectively. At June 30, 2024, the total related party receivable was $0.3 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 June 30, 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. For the six months ended June 30, 2024 and 2023, the Company had paid $1.4 million and $1.4 million in rent, respectively, and in connection with the Company’s Desk Share Agreement with TGTX, has invoiced TGTX approximately $1.0 million and $1.0 million, respectively, for its prorated share of the rent base. At June 30, 2024, there wasno balance 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 June 30, 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 $25.00 liquidation preference, plus* *accumulated and unpaid dividends to, but excluding, the redemption date.
An optional exchange to Fortress Series A Preferred Stock is available after 24 months from the issuance date so long as a sale of the PRV has not occurred. Additionally, if a PRV Sale has not occurred by September 30, 2024 the Cyprium PPS will either be automatically exchanged for Fortress Series A Preferred Stock or cash at the discretion of Fortress. The Cyprium PPS is fully and unconditionally guaranteed by Fortress.
- Segment Information
The Company operates intwo reportable segments, Dermatology Product Sales and Pharmaceutical and Biotechnology Product Development. The accounting policies of the Company are consistently applied to all segments. The following tables summarize, for the periods indicated, operating results from continued operations by reportable segment ($ in thousands):
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · · · · · Pharmaceutical · · | |||||||||
| · · · · · and · · · | |||||||||
| · · Dermatology · · Biotechnology · · · | |||||||||
| · · Products · · Product · · · | |||||||||
| Three Months Ended June 30, 2024 · Sales · Development · Consolidated | |||||||||
| Net revenue | | $14,855 | | $41 | | $14,896 | |||
| Cost of goods - product revenue | | (6,541) | | — | | (6,541) | |||
| Research and development | | (913) | | (11,758) | | (12,671) | |||
| Selling, general and administrative | | | (10,328) | | | (10,495) | | | (20,823) |
| Asset impairment | | | — | | | (2,649) | | | (2,649) |
| Other expense | | | (434) | | (602) | | | (1,036) | |
| Segment loss | | $(3,361) | | | (25,463) | | $(28,824) | ||
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · · · · · Pharmaceutical · · | |||||||||
| · · · · · and · · · | |||||||||
| · · Dermatology · · Biotechnology · · · | |||||||||
| · · Products · · Product · · · | |||||||||
| Six Months Ended June 30, 2024 · Sales · Development · Consolidated | |||||||||
| Net revenue | | $27,885 | | $41 | | $27,926 | |||
| Cost of goods - product revenue | | (13,357) | | (0) | | (13,357) | |||
| Research and development | | (8,797) | | (28,698) | | (37,495) | |||
| Selling, general and administrative | | | (18,748) | | | (20,029) | | | (38,777) |
| Asset impairment | | | — | | | (2,649) | | | (2,649) |
| Other expense | | (786) | | (2,708) | | (3,494) | |||
| Segment loss | | $(13,803) | | $(54,043) | | $(67,846) | |||
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · · · · · Pharmaceutical · · · | |||||||||
| · · · · · and · · · | |||||||||
| · · Dermatology · · Biotechnology · · · | |||||||||
| · · Products · · Product · · · | |||||||||
| Three Months Ended June 30, 2023 · Sales · Development · Consolidated | |||||||||
| Net revenue | | $17,172 | | $214 | | $17,386 | |||
| Cost of goods - product revenue | | (7,767) | | — | | (7,767) | |||
| Research and development | | (1,774) | | (30,368) | | | (32,142) | ||
| Selling, general and administrative | | (12,141) | | (12,298) | | | (24,439) | ||
| Asset impairment | | | (3,143) | | | — | | | (3,143) |
| Other expense | | | (710) | | (8,486) | | | (9,196) | |
| Segment loss | | $(8,363) | | $(50,938) | | $(59,301) | |||
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · · · · · Pharmaceutical · · · | |||||||||
| · · · · · and · · · | |||||||||
| · · Dermatology · · Biotechnology · · · | |||||||||
| · · Products · · Product · · · | |||||||||
| Six Months Ended June 30, 2023 · Sales · Development · Consolidated | |||||||||
| Net revenue | | $29,385 | | $430 | | $29,815 | |||
| Cost of goods - product revenue | | (14,216) | | — | | (14,216) | |||
| Research and development | | (3,807) | | (67,841) | | (71,648) | |||
| Selling, general and administrative | | (25,433) | | | (24,347) | | | (49,780) | |
| Asset impairment | | | (3,143) | | | — | | | (3,143) |
| Other expense | | | (1,285) | | (4,189) | | (5,474) | ||
| Segment loss | | $(18,499) | | $(95,947) | | $(114,446) | |||
The following tables summarize, for the periods indicated, total assets by reportable segment ($ in thousands):
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · · · · · Pharmaceutical · · | |||||||||
| · · · · · and · · · | |||||||||
| · · Dermatology · · Biotechnology · · · | |||||||||
| · · Products · · Product · · · | |||||||||
| June 30, 2024 · Sales · Development · Total Assets | |||||||||
| Intangible assets, net | | $18,658 | | $— | | $18,658 | |||
| Tangible assets | | | 46,531 | | | 80,496 | | | 127,027 |
| Total segment assets | | $65,189 | | $80,496 | | $145,685 | |||
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · · · · · Pharmaceutical · · | |||||||||
| · · · · · and · · · | |||||||||
| · · Dermatology · · Biotechnology · · · | |||||||||
| · · Products · · Product · · · | |||||||||
| December 31, 2023 · Sales · Development · Total Assets | |||||||||
| Intangible assets, net | | $20,287 | | $— | | $20,287 | |||
| Tangible assets | | | 56,562 | | | 90,677 | | | 147,239 |
| Total segment assets | | $76,849 | | $90,677 | | $167,526 | |||
- Revenues from Contracts and Significant Customers
Disaggregation of Total Revenue
Journey has the following actively marketed products, Qbrexza, Accutane, Amzeeq, Zilxi, Exelderm, Luxamend, Targadox, and Ximino (until September 2023). All of Journey’s product revenues are recorded in the U.S.
The table below summarizes the Company’s revenue for the periods presented ($ in thousands):
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three months ended June 30, · · Six Months Ended June 30, | ||||||||||||
| | 2024 | 2023 | 2024 | 2023 | ||||||||
| Revenue | | | | | | | | | | | | |
| Qbrexza | | $6,836 | | $8,079 | | $11,853 | | $12,173 | ||||
| Accutane | | | 5,719 | | | 5,579 | | | 11,538 | | | 10,227 |
| Amzeeq | | | 1,205 | | | 1,374 | | | 1,960 | | | 2,568 |
| Zilxi | | | 369 | | | 572 | | | 642 | | | 886 |
| Other / legacy product revenue | | | 726 | | | 1,357 | | | 1,892 | | | 3,272 |
| Collaboration revenue | | | — | | | 183 | | | — | | | 364 |
| Revenue – related party | | 41 | | 31 | | 41 | | 66 | ||||
| Other revenue | | | — | | | 211 | | | — | | 259 | |
| Total net revenue | | $14,896 | | $17,386 | | $27,926 | | $29,815 | ||||
Significant Customers
For the three and six-month periods ending June 30, 2024 and 2023, none of Journey’s dermatology products customers accounted for more than 10% of its total gross product revenue.
At June 30, 2024, two of Journey’s dermatology products customers accounted for more than 10% of its total accounts receivable balance at 18% and 10.8%. 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 and six months ended June 30, 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 and six months ended June 30, 2024 or 2023.
19. Subsequent Events
Fortress
On July 25, 2024, Fortress entered into the $50.0 million senior secured credit agreement with a maturity date of July 25, 2027 with Oaktree (the “New Oaktree Agreement”). The Company borrowed $35.0 million under the New Oaktree Agreement on the Closing Date and is eligible to draw up to an additional $15.0 million at the lenders’ discretion to support future business development activities. The New Oaktree Agreement replaces the Prior Oaktree Agreement 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). 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.
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. Both the Minimum Net Sales Test and the Liquidity Requirement will be reduced to $0 while theoutstanding principal balance is less than or equal to $10.0 million. The Liquidity Requirement is subject to a decrease to $5.0 million while the outstanding principal balance is between $10.0 million and $25.0 million, and also subject to an increase of $3.75 million in each instance if DFD-29 is not approved by the FDA by either March 31, 2025 or December 31, 2025 with a reversion of the approval-related increases upon approval. 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 common equity, 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 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.
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”). 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. The Warrants are immediately exercisable and will expire on July 25, 2031 and may be net exercised for no cash payment at the holder’s election. The Company also agreed to file a registration statement to register the resale of the shares of Company common stock issuable upon exercise of the Warrants.
Fortress Dividends
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 Company’s 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock (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.
Journey
On July 9, 2024, Journey entered into the SWK Amendment. The SWK Amendment increased the total amount of the Credit Facility from $20.0 million to $25.0 million. The $5.0 million of additional availability added in the Amendment will be drawn upon FDA approval of DFD-29, subject to Journey receiving approval on or before June 30, 2025.
Urica
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 Therapeutics, Inc. (“Crystalys”). Crystalys is a Delaware corporation incorporated in 2022 and seeded by leading life sciences institutional investors. Under the Transaction Documents, Urica sold the rights to its URAT1 inhibitor product candidate 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 securitized three percent (3%) royalty on future net sales of dotinurad to be paid by Crystalys, as well as the right to receive nominal cash reimbursement payments 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. Urica has committed to providing transition support to Crystalys for 90 days, and Crystalys is obliged to use commercially reasonable efforts to develop and commercialize dotinurad.
Checkpoint
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 of common stock. 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 will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares upon exercise of the Checkpoint July 2024 Common Stock Warrants with an exercise price of $2.05 per share and will expire five years following the issuance date. The total gross proceeds from the July 2024 Registered Direct Offering were approximately $12.0 million.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.