UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Fiscal Year Ended
or
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Transition Period from ____ to _____.
Commission File No.
(Exact Name of Registrant as Specified in its Charter)
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(State or Other Jurisdiction of Incorporation or Organization) |
| (I.R.S. Employer Identification No.) |
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| 10014 | |
(Address of Principal Executive Offices) |
| (Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
Title of Class |
| Trading Symbol(s) |
| Exchange Name |
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Securities registered pursuant to section 12(g) of the Act: None.
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ | Accelerated filer ☐ |
Smaller reporting company | |
| Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes
The aggregate market value of the voting stock held by non-affiliates of the registrant as of the last business day of the registrant’s most recently completed second fiscal quarter: $
Class of Stock |
| Outstanding Shares as of March 18, 2021 |
Common Stock, $0.001 par value |
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9.375% Series A Cumulative Redeemable Perpetual Preferred Stock, $0.001 par value |
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DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrant’s definitive proxy statement for its 2020 Annual Meeting of Stockholders are incorporated by reference into Part III hereof.
EXPLANATORY NOTE
Fortress Biotech, Inc., a Delaware corporation (the “Company”), is filing this Amendment No. 1 on Form 10-K/A (the “10-K/A”) to amend the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 (the “10-K”), originally filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2021, solely to correct the date of the independent auditor opinion. No other amendments have been made to the 10-K or to the audited financial statements for the fiscal year ending December 31, 2020.
This 10-K/A does not reflect events that may have occurred subsequent to the initial filing of the 10-K and does not modify or update the disclosure contained therein in any way, other than as required to reflect the amendments discussed above.
1
Item 8. Financial Statements and Supplementary Data.
The information required by this Item is set forth in the consolidated financial statements and notes thereto beginning at page F-1 of this Annual Report on Form 10-K/A.
2
PART IV
Item 15. Exhibits, Financial Statement Schedules.
The following financial statements are filed as part of this report:
F-2 | |
F-4 | |
F-5 | |
F-6 | |
F-8 | |
F-11 – F-77 |
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Report of Independent Registered Public Accounting Firm
Shareholders and Board of Directors
Fortress Biotech, Inc. and subsidiaries
New York, New York
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of Fortress Biotech, Inc. and subsidiaries (the “Company”) as of December 31, 2020 and 2019, the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the two years in the period ended December 31, 2020, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2020 and 2019, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2020, in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to the consolidated financial statements and (ii) involved especially challenging, subjective, or complex judgments. The communication of a critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Accounting for Oaktree Note
As described in Note 2 and Note 10 to the consolidated financial statements, in August 2020, the Company entered into a $60.0 million senior secured credit agreement with Oaktree (“Note”). In connection with the Oaktree Note, the Company issued warrants to Oaktree and certain of its affiliates to purchase up to 1,749,450 shares of common stock (see Note 14)
F-2
with a relative fair value of $4.4 million. In accounting for the Oaktree Note, the Company analyzed the Note and warrants and their related features for the appropriate accounting of the arrangement, including assessment of potential embedded derivatives.
We identified the accounting for the Oaktree Note as a critical audit matter. The principal considerations that led us to determine this matter was a critical audit matter included the inherent complexity in assessing the accounting for the Note and related embedded derivatives. Auditing these elements required complex auditor judgment and an increased level of audit effort, including the need for specialized knowledge and skill in assessing these elements.
The procedures we performed to address this critical audit matter included:
management’s evaluation of various terms and conditions in the debt agreement, and assessment of embedded derivatives.
● | Inspecting the underlying agreements and testing management’s evaluation and application of the relevant accounting guidance to the terms of the agreements. |
● | Utilizing personnel with specialized knowledge and skill with complex debt instruments to assist in assessing the analysis and accounting for the Note and its features including the warrants. |
We have served as the Company’s auditor since 2016.
/s/ BDO USA, LLP
Boston, Massachusetts
March 31, 2021
F-3
FORTRESS BIOTECH, INC. AND SUBSIDIARIES
Consolidated Balance Sheets
($ in thousands except for share and per share amounts)
December 31, | ||||||
2020 | 2019 | |||||
ASSETS |
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Current assets |
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Cash and cash equivalents | $ | | $ | | ||
Accounts receivable, net |
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Inventory |
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Other receivables - related party |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Operating lease right-of-use asset, net |
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Restricted cash |
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Long-term investment, at fair value |
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Intangible asset, net |
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Other assets |
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Total assets | $ | | $ | | ||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities |
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Accounts payable and accrued expenses | $ | | $ | | ||
Interest payable |
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Interest payable - related party |
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Income taxes payable | | | ||||
Notes payable, short-term |
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Operating lease liabilities, short-term |
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Derivative warrant liability |
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Partner company note payable, short-term | | | ||||
Total current liabilities |
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Notes payable, long-term (net of debt discount of $ |
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Operating lease liabilities, long-term |
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Partner company note payable, long-term |
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Other long-term liabilities |
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Total liabilities | | | ||||
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Commitments and contingencies |
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Stockholders’ equity |
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Cumulative redeemable perpetual preferred stock, $ |
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Common stock, $ |
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Common stock issuable, |
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Additional paid-in-capital |
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Accumulated deficit |
| ( |
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Total stockholders' equity attributed to the Company |
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Non-controlling interests |
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Total stockholders' equity |
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Total liabilities and stockholders' equity | $ | | $ | |
The accompanying notes are an integral part of these consolidated financial statements.
F-4
FORTRESS BIOTECH, INC. AND SUBSIDIARIES
Consolidated Statements of Operations
($ in thousands except for share and per share amounts)
Year Ended December 31, | ||||||
| 2020 |
| 2019 | |||
Revenue |
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Product revenue, net | $ | | $ | | ||
Revenue - related party |
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Net revenue |
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Operating expenses |
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Cost of goods sold - product revenue |
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Research and development |
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Research and development - licenses acquired |
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Selling, general and administrative |
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Total operating expenses |
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Loss from operations |
| ( |
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Other income (expense) |
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Interest income |
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Interest expense and financing fee |
| ( |
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Change in fair value of derivative liability |
| ( |
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Change in fair value of investments |
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Gain on deconsolidation of Caelum |
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Total other income (expense) |
| ( |
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Loss before income tax expense | ( | ( | ||||
Income tax expense | | | ||||
Net loss |
| ( |
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Less: net loss attributable to non-controlling interests |
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Net loss attributable to common stockholders | $ | ( | $ | ( | ||
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Net loss per common share - basic and diluted | $ | ( | $ | ( | ||
Net loss per common share attributable to non - controlling interests - basic and diluted | $ | ( | $ | ( | ||
Net loss per common share attributable to common stockholders - basic and diluted | $ | ( | $ | ( | ||
Weighted average common shares outstanding - basic and diluted |
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The accompanying notes are an integral part of these consolidated financial statements.
F-5
FORTRESS BIOTECH, INC. AND SUBSIDIARIES
Consolidated Statements of Changes in Stockholders’ Equity
($ in thousands except for share amounts)
| Common | Additional | Total | |||||||||||||||||||||||||
Series A Preferred Stock | Common Stock | Shares | Treasury | Paid-In | Accumulated | Non-Controlling | Stockholders' | |||||||||||||||||||||
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| Shares |
| Shares |
| Amount |
| Issuable |
| Stock |
| Capital |
| Deficit |
| Interests |
| Equity | ||||||||||
Balance at December 31, 2018 |
| | $ | |
| | $ | | $ | | $ | — | $ | | $ | ( | $ | | $ | | ||||||||
Stock-based compensation expense |
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Settlement of restricted stock units into common stock |
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| ( |
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Issuance of common stock under ESPP |
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Issuance of common stock for at-the-market offering, net |
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Issuance of Series A preferred stock for at-the-market offering, net |
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Issuance of Series A preferred stock for cash, net |
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Preferred A dividends declared and paid |
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| ( |
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Partner company’s offering, net |
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Partner company’s at-the-market offering, net |
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Issuance of partner company's common shares for license expenses |
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| ( |
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Issuance of partner company's common shares for research and development expenses |
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Issuance of partner company warrants in conjunction with Horizon Notes |
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Common shares issuable for 2017 Subordinated Note Financing interest expense |
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Common shares issued for 2017 Subordinated Note Financing interest expense |
| — |
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| ( |
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Common shares issuable for Opus interest expense |
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Common shares issued for Opus interest expense |
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| ( |
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Common shares issued for Opus debt |
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Non-controlling interest in subsidiaries |
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| ( |
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Deconsolidation of Caelum non-controlling interest |
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Net loss attributable to non-controlling interest |
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| ( |
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Net loss attributable to common stockholders |
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| ( |
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Balance at December 31, 2019 |
| | $ | |
| | $ | | $ | | ` | $ | — | ` | $ | | $ | ( | $ | | $ | |
The accompanying notes are an integral part of these consolidated financial statements.
F-6
FORTRESS BIOTECH, INC. AND SUBSIDIARIES
Consolidated Statements of Changes in Stockholders’ Equity
($ in thousands except for share amounts)
Common | Additional | Total | ||||||||||||||||||||||||||
Series A Preferred Stock | Common Stock | Shares | Treasury | Paid-In | Accumulated | Non-Controlling | Stockholders' | |||||||||||||||||||||
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| Shares | Shares |
| Amount |
| Issuable |
| Stock |
| Capital |
| Deficit |
| Interests |
| Equity | |||||||||||
Balance at December 31, 2019 |
| | $ | |
| | $ | | $ | | $ | — | $ | | $ | ( | $ | | $ | | ||||||||
Stock-based compensation expense |
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Issuance of common stock related to equity plans |
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Issuance of common stock under ESPP |
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Issuance of common stock for at-the-market offering, net |
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Preferred A dividends declared and paid |
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Repurchase of Series A preferred stock, net | ( |
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Retirement of Series A preferred stock | — |
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Issuance of Series A preferred stock for cash, net |
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Partner company’s offering, net |
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Partner companies' at-the-market offering, net |
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Partner company’s preferred stock offering, net |
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Issuance of common stock under partner company’s ESPP |
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Partner company’s dividends declared and paid |
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Partner company’s exercise of warrants for cash |
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Partner company’s exercise of options for cash |
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Reclass partner company's warrants from liability to equity |
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Issuance of partner company’s common shares for research and development expenses |
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Common shares issued for 2017 Subordinated Note Financing interest expense |
| — | — | | | ( | — | | — | — |
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Issuance of warrants in conjunction with Oaktree Note |
| — | — | — | — | — | — | | — | — |
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Non-controlling interest in partner companies |
| — | — | — | — | — | — | ( | — | |
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Net loss attributable to non-controlling interest |
| — | — | — | — | — | — | — | — | ( |
| ( | ||||||||||||||||
Net loss attributable to common stockholders |
| — | — | — | — | — | — | — | ( | — |
| ( | ||||||||||||||||
Balance at December 31, 2020 |
| | $ | |
| | $ | | $ | — | $ | — | $ | | $ | ( | $ | | $ | |
The accompanying notes are an integral part of these consolidated financial statements.
F-7
FORTRESS BIOTECH, INC. AND SUBSIDIARIES
Consolidated Statements of Cash Flows
($ in thousands)
For the Year Ended | ||||||
December 31, | ||||||
| 2020 |
| 2019 | |||
Cash Flows from Operating Activities: |
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Net loss | $ | ( | $ | ( | ||
Reconciliation of net loss to net cash used in operating activities: |
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Depreciation expense |
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Bad debt expense | |
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Amortization of debt discount |
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Non-cash interest | | | ||||
Amortization of product revenue license fee |
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Amortization of operating lease right-of-use assets |
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Stock-based compensation expense |
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Issuance of common stock for service | | | ||||
Issuance of partner company’s common shares for research and development expenses |
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Common shares issuable for 2017 Subordinated Note Financing interest expense |
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Common shares issued for 2017 Subordinated Note Financing interest expense | | | ||||
Common shares issuable for 2019 Notes interest expense | | | ||||
Common shares issued for 2019 Notes interest expense | | | ||||
Change in fair value of derivative liability |
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Change in fair value of investment |
| ( |
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Gain on deconsolidation of Caelum |
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Research and development-licenses acquired, expense |
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Increase (decrease) in cash and cash equivalents resulting from changes in operating assets and liabilities: |
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Accounts receivable |
| ( |
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Inventory |
| ( |
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Other receivables - related party |
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Prepaid expenses and other current assets |
| ( |
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Other assets |
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Accounts payable and accrued expenses |
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Accounts payable and accrued expenses - related party |
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Interest payable |
| ( |
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Interest payable - related party |
| ( |
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Income taxes payable | | | ||||
Lease liabilities |
| ( |
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Other long-term liabilities |
| ( |
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Net cash used in operating activities |
| ( |
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Cash Flows from Investing Activities: |
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Purchase of research and development licenses |
| ( |
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Purchase of property and equipment |
| ( |
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Purchase of intangible asset | ( | ( | ||||
Purchase of short-term investment (certificates of deposit) | | ( | ||||
Redemption of short-term investment (certificates of deposit) |
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Deconsolidation of Caelum |
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Net cash provided by (used in) continuing investing activities |
| ( |
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Net cash provided by discontinued investing activities |
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Net cash provided by (used in) investing activities |
| ( |
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The accompanying notes are an integral part of these consolidated financial statements.
F-8
FORTRESS BIOTECH, INC. AND SUBSIDIARIES
Consolidated Statements of Cash Flows
($ in thousands)
For the Year Ended | ||||||
December 31, | ||||||
2020 | 2019 | |||||
Cash Flows from Financing Activities: |
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Payment of Series A preferred stock dividends |
| $ | ( |
| $ | ( |
Purchase of treasury stock | ( | | ||||
Payment of costs related to purchase of treasury stock |
| ( |
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Proceeds from issuance of Series A preferred stock | | | ||||
Payment of costs related to issuance of Series A preferred stock | ( | ( | ||||
Proceeds from issuance of common stock for at-the-market offering | | | ||||
Payment of costs related to issuance of common stock for at-the-market offering |
| ( |
| ( | ||
Proceeds from issuance of Series A preferred stock for at-the-market offering | | | ||||
Payment of costs related to issuance of Series A preferred stock for at-the-market offering | | ( | ||||
Proceeds from issuance of common stock under ESPP | | | ||||
Proceeds from partner companies' ESPP | |
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Partner company’s dividends declared and paid | ( |
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Proceeds from partner companies' sale of stock |
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Payment of costs related to partner companies' sale of stock |
| ( |
| ( | ||
Proceeds from partner companies' at-the-market offering |
| |
| | ||
Payment of costs related to partner companies' at-the-market offering |
| ( |
| ( | ||
Proceeds from partner company's preferred stock offering | | | ||||
Payment of costs related to partner company's preferred stock offering | ( | | ||||
Proceeds from exercise of partner company’s warrants |
| |
| | ||
Proceeds from exercise of partner company’s options | | | ||||
Payment of debt issuance costs associated with 2017 Subordinated Note Financing |
| ( |
| ( | ||
Payment of debt issuance costs associated with 2018 Venture Notes |
| ( |
| ( | ||
Proceeds from partner company's Horizon Notes |
| |
| | ||
Payment of debt issuance costs associated with partner company's Horizon Notes |
| |
| ( | ||
Proceeds from Oaktree Note | | | ||||
Payment of debt issuance costs associated with Oaktree Note | ( | | ||||
Repayment of 2017 Subordinated Note Financing | ( | | ||||
Repayment of 2018 Venture Notes | ( | | ||||
Repayment of 2019 Notes | ( | | ||||
Repayment of partner company's Horizon Notes | ( | | ||||
Repayment of IDB Note |
| ( |
| | ||
Installment payment related to intangible asset | ( | | ||||
Net cash provided by financing activities |
| |
| | ||
Net increase in cash and cash equivalents and restricted cash |
| |
| | ||
Cash and cash equivalents and restricted cash at beginning of period |
| |
| | ||
Cash and cash equivalents and restricted cash at end of period | $ | | $ | | ||
|
| |||||
Supplemental disclosure of cash flow information: |
|
|
|
| ||
Cash paid for interest | $ | | $ | | ||
Cash paid for interest - related party | $ | | $ | |
The accompanying notes are an integral part of these consolidated financial statements.
F-9
FORTRESS BIOTECH, INC. AND SUBSIDIARIES
Consolidated Statements of Cash Flows
($ in thousands)
Year Ended December 31, | ||||||
2020 | 2019 | |||||
Supplemental disclosure of non-cash financing and investing activities: |
|
|
|
| ||
Settlement of restricted stock units into common stock | $ | | $ | | ||
Common shares issuable for license acquired | $ | | $ | | ||
Issuance of partner company warrants in conjunction with Horizon Notes | $ | | $ | | ||
Issuance of warrants in conjunction with Oaktree Note | $ | | $ | | ||
Common shares issued from 2017 Subordinated Note Financing interest expense | $ | | $ | | ||
Common shares issued for 2019 Notes | $ | | $ | | ||
Unpaid fixed assets | $ | | $ | | ||
Partner company's unpaid intangible assets | $ | | $ | | ||
Partner company's previous paid offering cost | $ | | $ | | ||
Reclass partner company's warrants from liability to equity | $ | | $ | | ||
Unpaid partner company’s offering cost | $ | | $ | | ||
Unpaid partner company’s at-the-market offering cost | $ | | $ | | ||
Unpaid partner company’s preferred stock offering cost | $ | | $ | | ||
Unpaid debt offering cost | $ | | $ | | ||
Unpaid at-the-market offering cost | $ | | $ | | ||
Unpaid Series A preferred stock offering cost | $ | | $ | | ||
Unpaid research and development licenses acquired | $ | | $ | | ||
Retirement of Series A preferred stock | $ | | $ | |
The accompanying notes are an integral part of these consolidated financial statements.
F-10
FORTRESS BIOTECH, INC. AND SUBSIDIARIES
Notes to the Consolidated Financial Statements
1. Organization and Description of Business
Fortress Biotech, Inc. (“Fortress” or the “Company”) is a biopharmaceutical company dedicated to acquiring, developing and commercializing pharmaceutical and biotechnology products and product candidates, which the Company does at the Fortress level, at its majority-owned and majority-controlled subsidiaries and joint ventures, and at entities the Company founded and in which it maintains significant minority ownership positions. Fortress has a talented and experienced business development team, comprising scientists, doctors and finance professionals, who identify and evaluate promising products and product candidates for potential acquisition by new or existing partner companies. Fortress through its partner companies has executed such arrangements in partnership with some of the world’s foremost universities, research institutes and pharmaceutical companies, including City of Hope National Medical Center, Fred Hutchinson Cancer Research Center, St. Jude Children’s Research Hospital, Dana-Farber Cancer Institute, Nationwide Children's Hospital, Cincinnati Children's Hospital Medical Center, Columbia University, the University of Pennsylvania, and AstraZeneca plc.
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 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, and public and private financings; to date, three partner companies are publicly-traded, and two have consummated strategic partnerships with industry leaders Alexion Pharmaceuticals, Inc. and InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Limited).
Several of our partner companies possess licenses to product candidate intellectual property, including Aevitas Therapeutics, Inc. (“Aevitas”), Avenue Therapeutics, Inc. (“Avenue”), Baergic Bio, Inc. (“Baergic”), Caelum Biosciences, Inc. (“Caelum”), Cellvation, Inc. (“Cellvation”), Checkpoint Therapeutics, Inc. (“Checkpoint”), Cyprium Therapeutics, Inc. (“Cyprium”), Helocyte, Inc. (“Helocyte”), Journey Medical Corporation (“Journey” or “JMC”), Mustang Bio, Inc. (“Mustang”) and Oncogenuity, Inc. ("Oncogenuity").
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 partner companies, the proceeds from the exercise of warrants and stock options. 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 Company’s current cash and cash equivalents are sufficient to fund 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 a partner company, grants or other arrangements to fully 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 plan and plans for expansion of its selling, general and administrative infrastructure will be curtailed. The Company 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. In addition to the foregoing, the Company does not expect any material impact on its development timelines, revenue levels and its liquidity due to the worldwide spread of COVID-19 (except as may be implicated by the Material Adverse Effect claimed by InvaGen in connection with their agreement with Avenue). However, the Company is continuing to assess the impact the spread of COVID-19 may have on its operations. Avenue will also continue to assess the alleged Material Adverse Effect claimed by InvaGen.
F-11
2. Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The Company’s consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The Company’s consolidated financial statements include the accounts of the Company and the accounts of the Company’s subsidiaries, listed above. All intercompany balances and transactions have been eliminated.
The accompanying consolidated financial statements include the accounts of the Company’s subsidiaries. For consolidated entities where the Company owns less than 100% of the subsidiary, the Company records net loss attributable to non-controlling interests in its consolidated statements of operations equal to the percentage of the economic or ownership interest retained in such entities by the respective non-controlling parties. The Company also consolidates subsidiaries in which it owns less than 50% of the subsidiary but maintains voting control. The Company continually assesses whether changes to existing relationships or future transactions may result in the consolidation or deconsolidation of partner companies.
Use of Estimates
The Company’s consolidated financial statements include certain amounts that are based on management’s best estimates and judgments. The Company’s significant estimates include, but are not limited to, useful lives assigned to long-lived assets, fair value of stock options and warrants, stock-based compensation, common stock issued to acquire licenses, investments, accrued expenses, provisions for income taxes and contingencies. Due to the uncertainty inherent in such estimates, actual results may differ from these estimates.
Revenue Recognition
The Company recognizes revenue under Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”). The core principle of this revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle:
Step 1: Identify the contract with the customer
Step 2: Identify the performance obligations in the contract
Step 3: Determine the transaction price
Step 4: Allocate the transaction price to the performance obligations in the contract
Step 5: Recognize revenue when the company satisfies a performance obligation
In order to identify the performance obligations in a contract with a customer, a company must assess the promised goods or services in the contract and identify each promised good or service that is distinct. A performance obligation meets ASC 606’s definition of a “distinct” good or service (or bundle of goods or services) if both of the following criteria are met:
The customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (i.e., the good or service is capable of being distinct).
The entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (i.e., the promise to transfer the good or service is distinct within the context of the contract).
If a good or service is not distinct, the good or service is combined with other promised goods or services until a bundle of goods or services is identified that is distinct.
F-12
The transaction price is the amount of consideration to which an entity expects to be entitled in exchange for transferring promised goods or services to a customer, excluding amounts collected on behalf of third parties (for example, some sales taxes). The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. Variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved.
The transaction price is allocated to each performance obligation on a relative standalone selling price basis. The transaction price allocated to each performance obligation is recognized when that performance obligation is satisfied, at a point in time or over time as appropriate.
The Company recognizes product revenue from sales of Ximino®, Targadox®, Exelderm®, Luxamend® and Ceracade®. The Company’s performance obligation to deliver products is satisfied at the point in time that the goods are delivered to the customer, which is when the customer obtains title to and has the risks and rewards of ownership of the products.
The Company has variable consideration in the form of rights of return, coupons, and price protection to customers. The Company uses an expected value method to estimate variable consideration and whether the transaction price is constrained. Payment is due within months of when the customer is invoiced, with discounts for prompt payment. The Company recorded expense related to returns reserve of $
Because the Company’s agreements for sales of product to its distributors can be cancelled early, prior to the termination date, they are deemed to have an expected duration of one year or less, and as such, the Company has elected the practical expedient in ASC 606-10-50-14(a) to not disclose information about its remaining performance obligations.
Discontinued Operations
Pursuant to the discontinued operations criteria set forth in ASC Subtopic 205-20-45, Presentation of Financial Statements, proceeds received from the Company’s sale of its holdings in National Holding Corporation were classified as cash provided by discontinued investing activities in the Company’s cash flow statement for the year ended December 31, 2019. See Note 3 for more information relating to the Company’s discontinued operations.
Fair Value Measurement
The Company follows accounting guidance on fair value measurements for financial assets and liabilities measured at fair value on a recurring basis. Under the accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability.
The accounting guidance requires fair value measurements be classified and disclosed in one of the following three categories:
Level 1: Quoted prices in active markets for identical assets or liabilities.
Level 2: Observable inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace.
Level 3: Unobservable inputs which are supported by little or no market activity and that are financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation.
F-13
The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.
Certain of the Company’s financial instruments are not measured at fair value on a recurring basis but are recorded at amounts that approximate their fair value due to their liquid or short-term nature, such as accounts payable, accrued expenses and other current liabilities.
Segment Reporting
The Company operates in
Cash and Cash Equivalents
The Company considers highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Cash and cash equivalents at December 31, 2020 and at December 31, 2019 consisted of cash and certificates of deposit in institutions in the United States. Balances at certain institutions have exceeded Federal Deposit Insurance Corporation insured limits and U.S. government agency securities.
Short-term Investments
The Company classifies its certificates of deposit as cash and cash equivalents or held to maturity in accordance with ASC 320, Investments - Debt and Equity Securities. The Company reassesses the appropriateness of the classification of its investments at the end of each reporting period.
At December 31, 2020, the Company had approximately $
Property and Equipment
Computer equipment, furniture & fixtures and machinery & equipment are recorded at cost and depreciated using the straight-line method over the estimated useful life of each asset. Leasehold improvements are amortized over the shorter of the estimated useful lives or the term of the respective leases.
In connection with Mustang’s cell processing facility, Mustang incurred costs for the design and construction of the facility and the purchase of equipment; $
Restricted Cash
The Company records cash held in trust or pledged to secure certain debt obligations as restricted cash. As of December 31, 2020, the Company had $
F-14
The following table provides a reconciliation of cash, cash equivalents, and restricted cash from the consolidated balance sheets to the consolidated statements of cash flows for the years ended 2020, and 2019:
December 31, | ||||||
($ in thousands) | 2020 | 2019 | ||||
Cash and cash equivalents |
| $ | |
| $ | |
Restricted cash |
| |
| | ||
Total cash and cash equivalents and restricted cash | $ | | $ | |
Inventories
Inventories comprise finished goods, which are valued at the lower of cost and net realizable value, on a first-in, first-out basis. The Company evaluates the carrying value of inventories on a regular basis, taking into account anticipated future sales compared with quantities on hand, and the remaining shelf life of goods on hand.
Accounts Receivable, net
Accounts receivable consists of amounts due to the Company for product sales of JMC. The Company’s accounts receivable reflects discounts for estimated early payment and for product estimated returns. Accounts receivable are stated at amounts due from customers, net of an allowance for doubtful accounts that are outstanding longer than the contractual payment terms are considered past due. The Company determines its allowance for doubtful accounts by considering a number of factors, including the length of time trade accounts receivable are past due and the customer’s current ability to pay its obligation to the Company. The Company writes off accounts receivable when they become uncollectible. For the years ended December 31, 2020 and 2019 the allowance for doubtful accounts was approximately $
The allowance for product estimated returns were $
Investments at Fair Value
The Company elects the fair value option for its long-term investments at fair value (see Note 6). The decision to elect the fair value option, which is irrevocable once elected, is determined on an instrument by instrument basis and applied to an entire instrument. The net gains or losses, if any, on an investment for which the fair value option has been elected are recognized as a change in fair value of investments on the Consolidated Statements of Operations.
The Company has various processes and controls in place to ensure that fair value is reasonably estimated. While the Company believes its valuation methods are appropriate and consistent with other market participants, the use of different methodologies or assumptions to determine the fair value of certain financial instruments could result in a different estimate of fair value at the reporting date.
Accounting for Warrants at Fair Value
The Company classifies as liabilities any contracts that (i) require net-cash settlement (including a requirement to net-cash settle the contract if an event occurs and if that event is outside the control of the Company) or (ii) give the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement).
The accounting treatment of derivative financial instruments requires that the Company record the warrants at their fair values as of the inception date of the agreement and at fair value as of each subsequent balance sheet date. Any change in fair value is recorded as non-operating, non-cash income or expense for each reporting period at each balance sheet date. The Company reassesses the classification of its derivative instruments at each balance sheet date. If the classification changes as a result of events during the period, the contract is reclassified as of the date of the event that caused the reclassification.
F-15
The Company assessed the classification of warrants issuable in connection with 2018 Venture Notes and determined that the Cyprium Contingently Issuable Warrants met the criteria for liability classification. Accordingly, the Company classified the Cyprium Contingently Issuable Warrants as a liability at their fair value and adjusted the instruments to fair value at each balance sheet date until the warrants were issued. Any change in the fair value of the Cyprium Contingently Issuable Warrants is recognized as “change in the fair value of derivative liabilities” in the Consolidated Statements of Operations.
During the year ended December 31, 2020, Cyprium raised approximately $
Opus Credit Facility, with Detachable Warrants
The Company accounted for the Opus Credit Facility (see Note 10) with detachable warrants in accordance with ASC 470, Debt. The Company assessed the classification of its common stock purchase warrants as of the date of the transaction and determined that such instruments met the criteria for equity classification. The warrants were reported on the Consolidated Balance Sheets as a component of additional paid in capital within stockholders’ equity.
The Company recorded the related issue costs and value ascribed to the warrants as a debt discount of the Opus Credit Facility. The discount was amortized utilizing the effective interest method over the term of the Opus Credit Facility. The unamortized discount, if any, upon repayment of the Opus Credit Facility would be expensed to interest expense. In accordance with ASC Subtopic 470-20, the Company determined the weighted average effective interest rate of the debt was approximately
As of December 31, 2019, Opus dissolved and distributed its assets among its Limited Partners. The dissolution did not impact any of the terms under the Opus Credit Facility. During the year ended December 31, 2020, the Company used certain proceeds from the Oaktree Note to pay off the $
Issuance of Debt and Equity
The Company issues complex financial instruments which include both equity and debt features. The Company analyzes each instrument under ASC 480, Distinguishing Liabilities from Equity, ASC 815, Derivatives and Hedging and, ASC 470, Debt, in order to establish whether such instruments include any embedded derivatives.
The Company accounted for the Oaktree Note with detachable warrants in accordance with ASC 470, Debt. The Company assessed the classification of its common stock purchase warrants as of the date of the transaction and determined that such instruments met the criteria for equity classification. The note proceeds were allocated between the Oaktree Note and the warrants on a relative fair value basis. The warrants were reported on the Consolidated Balance Sheets as a component of additional paid in capital within stockholders’ equity.
The Company recorded the related issue costs and value ascribed to the warrants as a debt discount of the Oaktree Note. The discount was amortized utilizing the effective interest method over the term of the Oaktree Note. The unamortized discount, if any, upon repayment of the Oaktree Note would be expensed to interest expense. In accordance with ASC Subtopic 470-20, the Company determined the weighted average effective interest rate of the debt was approximately
F-16
Long-Lived Assets
Long-lived assets, primarily fixed assets, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets might not be recoverable. The Company will perform a periodic assessment of assets for impairment in the absence of such information or indicators. Conditions that would necessitate an impairment assessment include a significant decline in the observable market value of an asset, a significant change in the extent or manner in which an asset is used, or a significant adverse change that would indicate that the carrying amount of an asset or group of assets is not recoverable. For long-lived assets to be held and used, the Company would recognize an impairment loss only if its carrying amount is not recoverable through its undiscounted cash flows and measures the impairment loss based on the difference between the carrying amount and estimated fair value. As of December 31, 2020 and 2019 there were
Research and Development
Research and development costs are expensed as incurred. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. Upfront and milestone payments due to third parties that perform research and development services on the Company’s behalf will be expensed as services are rendered or when the milestone is achieved.
Research and development costs primarily consist of personnel related expenses, including salaries, benefits, travel, and other related expenses, stock-based compensation, payments made to third parties for license and milestone costs related to in-licensed products and technology, payments made to third party contract research organizations for preclinical and clinical studies, investigative sites for clinical trials, consultants, the cost of acquiring and manufacturing clinical trial materials, and costs associated with regulatory filings, laboratory costs and other supplies.
In accordance with ASC 730-10-25-1, Research and Development, costs incurred in obtaining technology licenses are charged to research and development expense if the technology licensed has not reached commercial feasibility and has no alternative future use. Such licenses purchased by the Company require substantial completion of research and development, regulatory and marketing approval efforts in order to reach commercial feasibility and has no alternative future use. Accordingly, the total purchase price for the licenses acquired during the period was reflected as research and development - licenses acquired on the Consolidated Statements of Operations for the years ended December 31, 2020 and 2019.
Contingencies
The Company records accruals for contingencies and legal proceedings expected to be incurred in connection with a loss contingency when it is probable that a liability has been incurred and the amount can be reasonably estimated.
If a loss contingency is not probable but is reasonably possible, or is probable but cannot be estimated, the nature of the contingent liability, together with an estimate of the range of possible loss if determinable and material, would be disclosed.
Leases
Effective January 1, 2019, the Company accounts for its leases under ASC 842, Leases. Under this guidance, arrangements meeting the definition of a lease are classified as operating or financing leases and are recorded on the consolidated balance sheet as both a right-of-use asset and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company's incremental borrowing rate. Lease liabilities are increased by interest and reduced by payments each period, and the right-of-use asset is amortized over the lease term. For operating leases, interest on the lease liability and the amortization of the right-of-use asset result in straight-line rent expense over the lease term. For finance leases, interest on the lease liability and the amortization of the right-of-use asset results in front-loaded expense over the lease term. Variable lease expenses are recorded when incurred.
F-17
In calculating the right-of-use asset and lease liability, the Company elects to combine lease and non-lease components. The Company continues to account for leases in the prior period consolidated financial statements under ASC Topic 840, Leases.
Stock-Based Compensation
The Company expenses stock-based compensation to employees and non-employees over the requisite service period based on the estimated grant-date fair value of the awards and forfeitures, which are recorded upon occurence.
For stock-based compensation awards to non-employees, prior to the adoption of ASU 2018-07 on January 1, 2019, the Company remeasured the fair value of the non-employee awards at each reporting period prior to vesting and finally at the vesting date of the award. Changes in the estimated fair value of these non-employee awards were recognized as compensation expense in the period of change. Subsequent to the adoption of ASU 2018-07, the Company recognizes non-employees compensation costs over the requisite service period based on a measurement of fair value for each stock award at the time the award is granted.
The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model. The assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment.
Income Taxes
The Company accounts for income taxes under ASC 740, Income Taxes (“ASC 740”). ASC 740 requires the recognition of deferred tax assets and liabilities for both the expected impact of differences between the financial statement and tax basis of assets and liabilities and for the expected future tax benefit to be derived from tax loss and tax credit carry forwards. ASC 740 additionally requires a valuation allowance to be established when it is more likely than not that all or a portion of deferred tax assets will not be realized.
ASC 740 also clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. ASC 740 also provides guidance on de-recognition, classification, interest and penalties, accounting in interim period, disclosure and transition. Based on the Company’s evaluation, it has been concluded that there are no significant uncertain tax positions requiring recognition in the Company’s financial statements. The 2017 through 2019 tax years are the only periods subject to examination upon filing of appropriate tax returns. The Company believes that its income tax positions and deductions would be sustained on audit and does not anticipate any adjustments that would result in a material change to its financial position.
The Company’s policy for recording interest and penalties associated with audits is to record such expense as a component of income tax expense. There were no amounts accrued for penalties or interest as of or during the years ended December 31, 2020 and 2019. Management is currently unaware of any issues under review that could result in significant payments, accruals or material deviations from its position.
Non-Controlling Interests
Non-controlling interests in consolidated entities represent the component of equity in consolidated entities held by third parties. Any change in ownership of a subsidiary while the controlling financial interest is retained is accounted for as an equity transaction between the controlling and non-controlling interests.
Comprehensive Loss
The Company’s comprehensive loss is equal to its net loss for all periods presented.
F-18
Recently Adopted Accounting Pronouncements
In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820), - Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement, which makes a number of changes meant to add, modify or remove certain disclosure requirements associated with the movement amongst or hierarchy associated with Level 1, Level 2 and Level 3 fair value measurements. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. Early adoption is permitted upon issuance of the update. The Company adopted ASU No. 2018-13 as of January 1, 2020. The adoption of this update did not have a material impact on the Company’s consolidated financial statements.
In June 2018, the FASB issued ASU 2018-07, “Improvements to Nonemployee Share-Based Payment Accounting”, which simplifies the accounting for share-based payments granted to nonemployees for goods and services. Under the ASU, most of the guidance on such payments to nonemployees would be aligned with the requirements for share-based payments granted to employees. The changes take effect for public companies for fiscal years starting after December 15, 2018, including interim periods within that fiscal year. For all other entities, the amendments are effective for fiscal years beginning after December 15, 2019, and interim periods within fiscal years beginning after December 15, 2020. Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606. The Company adopted ASU No. 2018-07 as of January 1, 2019. The adoption of this update did not have a material impact on the Company’s consolidated financial statements.
In July 2017, the FASB issued ASU 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480) and Derivatives and Hedging (Topic 815): I. Accounting for Certain Financial Instruments with Down Round Features; II. Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. Part I of this update addresses the complexity of accounting for certain financial instruments with down round features. Down round features are features of certain equity-linked instruments (or embedded features) that result in the strike price being reduced on the basis of the pricing of future equity offerings. Current accounting guidance creates cost and complexity for entities that issue financial instruments (such as warrants and convertible instruments) with down round features that require fair value measurement of the entire instrument or conversion option. Part II of this update addresses the difficulty of navigating Topic 480, Distinguishing Liabilities from Equity, because of the existence of extensive pending content in the FASB Accounting Standards Codification. This pending content is the result of the indefinite deferral of accounting requirements about mandatorily redeemable financial instruments of certain nonpublic entities and certain mandatorily redeemable noncontrolling interests. The amendments in Part II of this update do not have an accounting effect. This ASU is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018. The adoption of this ASU on January 1, 2019, did not have a material impact on the Company's consolidated financial statements.
In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) in order to increase transparency and comparability among organizations by, among other provisions, recognizing lease assets and lease liabilities on the balance sheet for those leases classified as operating leases under previous GAAP. For public companies, ASU 2016-02 is effective for fiscal years beginning after December 15, 2018 (including interim periods within those periods) using a modified retrospective approach and early adoption is permitted. In transition, entities may also elect a package of practical expedients that must be applied in its entirety to all leases commencing before the adoption date, unless the lease is modified, and permits entities to not reassess (a) the existence of a lease, (b) lease classification or (c) determination of initial direct costs, as of the adoption date, which effectively allows entities to carryforward accounting conclusions under previous U.S. GAAP. In July 2018, the FASB issued ASU 2018-11, Leases (Topic 842): Targeted Improvements, which provides entities an optional transition method to apply the guidance under Topic 842 as of the adoption date, rather than as of the earliest period presented. The Company adopted Topic 842 on January 1, 2019, using the optional transition method by recording a right of use asset of $
F-19
Recent Accounting Pronouncements
In June 2016, the FASB issued ASU 2016-13, “Financial Instruments – Credit Losses”. The ASU sets forth a “current expected credit loss” (CECL) model which requires the Company to measure all expected credit losses for financial instruments held at the reporting date based on historical experience, current conditions, and reasonable supportable forecasts. This replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets measured at amortized cost and applies to some off-balance sheet credit exposures. This ASU is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years, with early adoption permitted. Recently, the FASB issued the final ASU to delay adoption for smaller reporting companies to calendar year 2023. The Company is currently assessing the impact of the adoption of this ASU on its consolidated financial statements.
In December 2019, the FASB issued ASU No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The Company adopted the new guidance in the first quarter of 2021 and the adoption of this guidance did not to have a material impact on the financial statements.
3. Discontinued Operations
On November 14, 2018, the Company announced that it had reached an agreement with NHC Holdings, LLC (“NHC”) to sell all of its shares of National Holdings Corporation, a diversified independent brokerage company (together with its subsidiaries, herein referred to as “NHLD” or “National”) for total consideration of $
The table below depicts the cash flows from the transaction for the year ended December 31, 2019:
For the Year Ended | |||
December 31, | |||
($ in thousands) |
| 2019 | |
Investing activities |
|
| |
Proceeds from sale of National | $ | | |
Total cash provided by discontinued investing activities | $ | |
4. Collaboration and Stock Purchase Agreements
Caelum
Agreement with Alexion
In January 2019, Caelum, a subsidiary of the Company at that time, entered into a Development, Option and Stock Purchase Agreement (the "DOSPA") and related documents by and among Caelum, Alexion Therapeutics, Inc. ("Alexion"), the Company and Caelum security holders parties thereto (including Fortress, the "Sellers"). Under the terms of the agreement, Alexion purchased a
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The Company deconsolidated its holdings in Caelum immediately prior to the execution of the DOSPA. Following the DOSPA execution, the Company owns approximately
January | |||
($ in thousands) |
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ASSETS |
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Current assets |
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Cash and cash equivalents | $ | | |
Prepaid expenses and other current assets |
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Total current assets | $ | | |
LIABILITIES |
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Current liabilities |
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Accounts payable and accrued expenses | $ | | |
Interest payable |
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Interest payable - related party |
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Note payable - related party |
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Note payable |
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Warrant liability |
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Total current liabilities |
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Net liability impacted by deconsolidation | $ | |
In connection with this transaction the Company recorded a gain resulting from the deconsolidation of Caelum on its consolidated financial statements for the year ended December 31, 2019:
Gain on | |||
deconsolidation of | |||
($ in thousands) |
| Caelum | |
Fair value of Caelum | $ | | |
Net liabilities deconsolidated |
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Non-controlling interest share |
| ( | |
Write off of MSA fees due Fortress |
| ( | |
Gain on deconsolidation of Caelum | $ | |
In December 2019, following FDA feedback which resulted in the redesign and expansion of Caelum’s planned clinical development program for CAEL-101, Caelum entered into an Amended and Restated DOSPA (“A&R DOSPA”), which amended the terms of the existing agreement with Alexion. The amendment modified the terms of Alexion’s option to acquire the remaining equity in Caelum based on data from the expanded Phase II/III trials. The amendment also modified the development-related milestone events associated with the initial $
On December 12, 2020, AstraZeneca (“AZ”) announced its intention to acquire Alexion, with the acquisition expected to close by the third quarter of 2021, as the acquisition is subject to approval by both AZ and Alexion shareholders, as well as certain regulatory approvals, share listing approvals, and other customary closing conditions. The acquisition of Alexion by AZ triggers the Change of Control clause in the A&R DOSPA, such that Alexion’s purchase option expires on the date that is six months after the closing of any Change of Control.
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Avenue
Agreement with InvaGen
On November 12, 2018, Avenue entered into a Stock Purchase and Merger Agreement (the “Avenue SPMA”) with InvaGen Pharmaceuticals Inc. (“InvaGen”), and Madison Pharmaceuticals Inc. (the “Merger Sub”), under which Avenue would be sold to InvaGen in a two-stage transaction. The first stage of the strategic transaction between InvaGen and Avenue closed in February 2019. InvaGen acquired approximately
In October 2020, InvaGen communicated to Avenue that it believes a Material Adverse Effect (as defined in the Avenue SPMA) has occurred due to the impact of the COVID-19 pandemic on potential commercialization and projected sales of IV Tramadol, which means it is possible InvaGen could attempt to avoid its obligation to consummate the second stage closing under the Avenue SPMA, terminate the Avenue SPMA, and/or pursue monetary claims against Avenue and/or Fortress. Avenue disagrees with InvaGen’s assertion that a Material Adverse Effect has occurred and has advised InvaGen of this position.
In February 2020, the U.S. Food and Drug Administration (“FDA”) accepted the submission of Avenue’s’ New Drug Application (“NDA”) for IV Tramadol for review and assigned a Prescription Drug User Fee Act (“PDUFA”) date of October 10, 2020. In October 2020, Avenue announced that it had received a Complete Response Letter (“CRL”) from the FDA regarding Avenue’s NDA for IV Tramadol. The FDA held a Type A meeting with Avenue in November 2020 to discuss the issues outlined in the CRL. On February 12, 2021 Avenue resubmitted its NDA to the FDA for IV Tramadol. The NDA resubmission followed the receipt of the official minutes from Avenue’s Type A meeting with the FDA. The NDA resubmission included revised language relating to the proposed product label and a report relating to terminal sterilization validation. On February 26, 2021, Avenue received an acknowledgement letter from the FDA that Avenue’s resubmission of its NDA is a complete, class 1 response to the CRL, and a PDUFA goal date was set for April 12, 2021.
In connection with the resubmission of Avenue’s NDA, InvaGen communicated to Avenue that it believes the proposed label for IV Tramadol under certain circumstances would constitute a Material Adverse Effect on the purported basis that the proposed label for IV Tramadol would make the product commercially unviable, and in addition that the indiciation that the FDA approves may fail to satisfy a condition precedent to InvaGen’s obligation to consummate the second stage closing of the Avenue SPMA. Avenue has notified InvaGen that it disagrees with InvaGen’s assertions. Nevertheless, InvaGen may seek to avoid its obligation to consummate the second stage closing under the Avenue SPMA, terminate the Avenue SPMA, and/or pursue monetary claims against Avenue and/or Fortress.
Over the past several months, Avenue has communicated with InvaGen relating to InvaGen’s assertions. Nevertheless, InvaGen has communicated to Avenue its desire to consider all options on the proposed merger, including the option to not consummate the merger. This indicates that InvaGen may attempt to avoid its obligations under the Avenue SPMA to consummate the merger, terminate the Avenue SPMA, and/or pursue monetary claims against Avenue and/or Fortress. As a result, the possible timing and likelihood of the completion of the merger are uncertain, and, accordingly, there can be no assurance that such transaction will be completed on the expected terms, anticipated schedule, or at all. During the pendency of any dispute regarding these matters, Avenue may be, and so long as the Avenue SPMA remains in place Avenue will be, prohibited from engaging in a change-of-control transaction, selling its rights to IV Tramadol or effecting an equity or debt financing, in each case without the prior written consent of InvaGen.
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Subject to the terms and conditions described in the Avenue SPMA, InvaGen may also provide interim financing to Avenue in an amount of up to $
Prior to the closing of the Merger Transaction, Avenue will enter into a Contingent Value Rights Agreement (the “CVR Agreement”) with a trust company as rights agent, pursuant to which holders of common shares of Avenue, other than InvaGen (each, a “Holder”), will be entitled to receive on Contingent Value Right (“CVR”) for each share held immediately prior to the Merger Transaction.
Each CVR represents the right of its holder to receive a contingent cash payment pursuant to the CVR Agreement upon the achievement of certain milestones. If, during the period commencing on the day following the closing of the Merger Transaction until December 31, 2028, IV Tramadol generates at least $
5. Property and Equipment
Fortress’ property and equipment consisted of the following:
| Useful Life |
| December 31, |
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($ in thousands) | (Years) | 2020 | 2019 | ||||||
Computer equipment |
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Furniture and fixtures |
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Machinery & equipment |
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Leasehold improvements |
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Construction in progress 1 |
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Total property and equipment |
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Less: Accumulated depreciation |
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Property and equipment, net | $ | | $ | |
Note 1: Relates to the Mustang cell processing facility.
Depreciation expenses of Fortress’ property and equipment for the years ended December 31, 2020 and 2019 was $
6. Fair Value Measurements
Certain of the Company’s financial instruments are not measured at fair value on a recurring basis but are recorded at amounts that approximate their fair value due to their liquid or short-term nature, such as accounts payable, accrued expenses and other current liabilities.
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Fair Value of Caelum
The Company values its investment in Caelum in accordance with ASC Topic 820, Fair Value Measurements and Disclosures, and as of December 31, 2020, estimated the fair value to be $
As of December 31, 2019, the estimated fair value of the Company’s investment in Caelum was $
Caelum Warrant Liability
The fair value of Caelum's warrant liability, which was issued in connection with Caelum’s convertible note, was written up to the full value of the liability prior to the conversion of the notes in January 2019 (see Note 10). The fair value 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 Caelum’s warrant liabilities that are categorized within Level 3 of the fair value hierarchy as of January 2019 was as follows:
| January | ||
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Risk-free interest rate |
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Expected dividend yield |
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Expected term in years |
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Expected volatility |
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In connection with the DOSPA Caelum's convertible notes automatically converted into common shares of Caelum and the warrant liability payable to the placement agent in connection with the placement of the convertible notes was also issued (see Note 10).
Fair Value of | |||
Derivative | |||
Warrant | |||
($ in thousands) |
| Liability | |
Beginning balance at January 1, 2019 | $ | | |
Issuance of warrant due to conversion of note |
| ( | |
Ending balance at December 31, 2019 | $ | |
Caelum Convertible Notes
Caelum’s convertible debt was measured at fair value using the Monte Carlo simulation valuation methodology. A summary of the weighted average (in aggregate) significant unobservable inputs (Level 3 inputs) used in measuring Caelum’s convertible debt that is categorized within Level 3. As of December 31, 2018, conversion of the Caelum Convertible Notes was probable and as such the fair value approximated cost. The Caelum Convertible Notes were converted during 2019. As of January 2019 the following inputs were utilized to derive the notes’ fair value:
January |
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Risk-free interest rate |
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Expected dividend yield |
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Expected term in years |
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Expected volatility |
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| Caelum | ||
Convertible | |||
Notes, at fair | |||
($ in thousands) | value | ||
Beginning balance at January 1, 2019 | $ | | |
Change in fair value of convertible notes |
| ( | |
Ending balance at December 31, 2019 | $ | |
Cyprium Warrant Liability
The fair value of the Cyprium Contingently Issuable Warrants in connection with the 2018 Venture Debt was determined by applying management’s estimate of the probability of issuance of the Contingently Issuable Warrants together with an option-pricing model, with the following key assumptions:
December 31, |
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2020 | 2019 |
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Risk-free interest rate |
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Expected dividend yield |
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Expected term in years |
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Expected volatility |
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Probability of issuance of the warrant |
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Cyprium | |||
Contingently | |||
Issuable Warrant | |||
($ in thousands) | Liability | ||
Beginning balance at January 1, 2019 | $ | | |
Change in fair value | | ||
Ending balance at December 31, 2019 | $ | | |
Change in fair value | | ||
Reclass partner company's warrants from liability to equity | ( | ||
Ending balance at December 31, 2020 | $ | |
The following tables classify into the fair value hierarchy of Fortress’ financial instruments, measured at fair value on a recurring basis on the Consolidated Balance Sheets as of December 31, 2020 and 2019:
Fair Value Measurement as of December 31, 2020 | ||||||||||||
($ in thousands) |
| Level 1 |
| Level 2 |
| Level 3 |
| Total | ||||
Assets |
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Fair value of investment in Caelum | $ | — | $ | — | $ | | $ | | ||||
Total | $ | — | $ | — | $ | | $ | |
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Fair Value Measurement as of December 31, 2019 | ||||||||||||
($ in thousands) |
| Level 1 |
| Level 2 |
| Level 3 |
| Total | ||||
Assets |
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Fair value of investment in Caelum |
| $ | — |
| $ | — |
| $ | |
| $ | |
Total |
| $ | — |
| $ | — |
| $ | |
| $ | |
Fair Value Measurement as of December 31, 2019 | ||||||||||||
($ in thousands) |
| Level 1 |
| Level 2 |
| Level 3 |
| Total | ||||
Liabilities |
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Warrant liabilities |
| $ | — |
| $ | — |
| $ | |
| $ | |
Total |
| $ | — |
| $ | — |
| $ | |
| $ | |
The table below provides a roll forward of the changes in fair value of Level 3 financial instruments for the years ended December 31, 2020 and 2019:
Investment in | Warrant | ||||||||
($ in thousands) |
| Caelum |
| Liabilities |
| Total | |||
Balance at December 31, 2019 | $ | | $ | | $ | | |||
Change in fair value | | | | ||||||
Reclass partner company's warrants from liability to equity | | ( | ( | ||||||
Change in fair value of investments | | | | ||||||
Balance at December 31, 2020 | $ | | $ | | $ | |
Investment | Caelum Convertible | Warrants | ||||||||||
($ in thousands) |
| in Caelum | Notes | liabilities |
| Total | ||||||
Balance at December 31, 2018 | $ | | $ | | $ | | $ | | ||||
Conversion of convertible notes |
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Issuance of warrant |
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Fair value of investment |
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Change in fair value of derivative liability |
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Balance at December 31, 2019 | $ | | $ | | $ | | $ | |
7. Licenses Acquired
In accordance with ASC 730-10-25-1, Research and Development, costs incurred in obtaining technology licenses are charged to research and development expense if the technology licensed has not reached commercial feasibility and has no alternative future use. The licenses purchased by the Company require substantial completion of research and development, regulatory and marketing approval efforts in order to reach commercial feasibility and has no alternate use. As such, for the years ended December 31, 2020 and 2019, the total purchase price of licenses acquired, totaling approximately $
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For the years ended December 31, 2020 and 2019, the Company’s research and development-licenses acquired are comprised of the following:
For the Year Ended | ||||||
December 31, | ||||||
($ in thousands) |
| 2020 |
| 2019 | ||
Partner companies: |
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Avenue | $ | | $ | | ||
Aevitas | | | ||||
Baergic |
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Cellvation |
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Helocyte | | | ||||
Mustang | | | ||||
Oncogenuity | | | ||||
Total | $ | | $ | |
Aevitas
License Agreement with University of Massachusetts
On December 17, 2020, Aevitas entered into an exclusive license agreement (the “UMass license”) with the University of Massachusetts to obtain an exclusive license to the University’s intellectual property rights which relate to gene therapy for Factor H deficiency. For the year ended December 31, 2020, Aevitas recorded $
Development milestone payments totaling approximately $
Avenue
License Agreement with Revogenex Ireland Ltd
In 2015, the Company purchased an exclusive license to IV Tramadol for the U.S. market from Revogenex, a privately held company in Dublin, Ireland, for an upfront fee of $
Baergic
AstraZeneca AB License Agreement
On December 17, 2019, Baergic entered into
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Pursuant to the terms of the AZ License, Baergic paid an upfront fee of $
Development milestone payments totaling approximately $
For the years ended December 31, 2020 and 2019, Baergic recorded expense of approximately $
Cincinnati Children’s License Agreement
Pursuant to the terms of the Cincinnati License, Baergic paid an upfront fee of $
For the years ended December 31, 2020 and 2019, Baergic recorded expense of approximately $
Cellvation
University of Texas Health Science Center at Houston License Agreement
In October 2016, Cellvation entered into a license agreement with the University of Texas Health Science Center at Houston (“University of Texas”) for the treatment of traumatic brain injury using Autologous Bone Marrow Mononuclear Cells (the “Initial TBI License”) for an upfront cash fee of approximately $
In addition, Cellvation entered into a secondary license with the University of Texas for a method and apparatus for conditioning cell populations for cell therapies (the “Second TBI License”). Cellvation paid an upfront fee of $
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For the years ended December 31, 2020 and 2019, Cellvation recorded expense of approximately $
Checkpoint
Dana-Farber Cancer Institute License Agreement
In March 2015, Checkpoint entered into an exclusive license agreement with Dana-Farber Cancer Institute (“Dana-Farber”) to develop a portfolio of fully human immuno-oncology targeted antibodies. The portfolio of antibodies licensed from Dana-Farber include antibodies targeting PD-L1, GITR and CAIX. Under the terms of the agreement, Checkpoint paid Dana-Farber an up-front licensing fee of $
In connection with the license agreement with Dana-Farber, Checkpoint entered into a collaboration agreement with TGTX, which was amended and restated in June 2019, to develop and commercialize the anti-PD-L1 and anti-GITR antibody research programs in the field of hematological malignancies, while Checkpoint retains the right to develop and commercialize these antibodies in the field of solid tumors. Michael Weiss, Chairman of the Board of Directors of Checkpoint is also the Executive Chairman, President and Chief Executive Officer and a stockholder of TGTX. Under the terms of the original agreement, TGTX paid Checkpoint $
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Adimab, LLC Collaboration Agreement
In October 2015, Fortress entered into a collaboration agreement with Adimab to discover and optimize antibodies using their proprietary core technology platform. Under this agreement, Adimab optimized cosibelimab, Checkpoint's anti-PD-L1 antibody which it originally licensed from Dana-Farber. In January 2019, Fortress transferred the rights to the optimized antibody to Checkpoint, and Checkpoint entered into a collaboration agreement directly with Adimab on the same day. Under the terms of the agreement, Adimab is eligible to receive payments up to an aggregate of approximately $
NeuPharma, Inc. License Agreement
In March 2015, the Company entered into an exclusive license agreement with NeuPharma, Inc. (“NeuPharma”) to develop and commercialize novel irreversible, 3rd generation epidermal growth factor receptor (“EGFR”) inhibitors including CK-101, on a worldwide basis (other than certain Asian countries). On the same date, the Company assigned all of its right and interest in the EGFR inhibitors to Checkpoint. Under the terms of the agreement, Checkpoint paid NeuPharma an up-front licensing fee of $
Jubilant Biosys Limited License Agreement
In May 2016, Checkpoint entered into a license agreement with Jubilant Biosys Limited (“Jubilant”), whereby Checkpoint obtained an exclusive, worldwide license (the “Jubilant License”) to Jubilant’s family of patents covering compounds that inhibit BRD4, a member of the BET domain for cancer treatment, including CK-103. Under the terms of the Jubilant License, Checkpoint paid Jubilant an up-front licensing fee of $
In connection with the Jubilant License, Checkpoint entered into a sublicense agreement with TGTX (the “Sublicense Agreement”), a related party, to develop and commercialize the compounds licensed in the field of hematological malignancies, with Checkpoint retaining the right to develop and commercialize these compounds in the field of solid tumors. Under the terms of the Sublicense Agreement, TGTX paid Checkpoint $
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The collaborations with TGTX each contain single material performance obligations under Topic 606, which is the granting of a license that is functional intellectual property. Checkpoint's performance obligation was satisfied at the point in time when TGTX had the ability to use and benefit from the right to use the intellectual property. The performance obligations of the original agreements were satisfied prior to the adoption of Topic 606. The performance obligation of the amendment to the collaboration agreement was satisfied in June 2019.
The milestone payments are based on successful achievement of clinical development, regulatory, and sales milestones. Because these payments are contingent on the occurrence of a future event, they represent variable consideration and are constrained and included in the transaction price only when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. The sales-based royalty payments are recognized as revenue when the subsequent sales occur. Checkpoint also receives variable consideration for certain research and development, out-of-pocket material costs and patent maintenance related activities that are dependent upon the Company's actual expenditures under the collaborations and are constrained and included in the transaction price only when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. Revenue is recognized approximately when the amounts become due because it relates to an already satisfied performance obligation. For the year ended December 31, 2020, Checkpoint recognized the achievement of a clinical development milestone under its collaboration agreement with TGTX based upon their dosing of a 12th patient in a phase 1 clinical trial of cosibelimab. For the year ended December 31, 2019, Checkpoint did
Cyprium
License Agreement with the Eunice Kennedy Shriver National Institute of Child Health and Human Development
In March 2017, Cyprium and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (“NICHD”), part of the National Institutes of Health (“NIH”), entered into a Cooperative Research and Development Agreement to advance the clinical development of Phase 3 candidate CUTX-101 (copper histidinate injection) for the treatment of Menkes disease. Cyprium and NICHD also entered into a worldwide, exclusive license agreement to develop and commercialize AAV-based ATP7A gene therapy for use in combination with CUTX-101 for the treatment of Menkes disease and related copper transport disorders. Cyprium made an upfront payment of $
Helocyte
License Agreement with the City of Hope
Helocyte entered into the original license agreement with City of Hope National Medical Center (“COH”) on March 31, 2015, to secure: (i) an exclusive worldwide license for two immunotherapies for Cytomegalovirus (“CMV”) control in the post-transplant setting (known as Triplex and PepVax). In consideration for the license and option, Helocyte made an upfront payment of $
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If Helocyte successfully develops and commercializes Triplex, COH is eligible to receive up to $
In April 2015, Helocyte secured the exclusive worldwide rights to an immunotherapy for the prevention of congenital CMV: ConVax (formerly Pentamer) from COH for an upfront payment of $
License with the National Institute of Allergy and Infectious Disease (NIAD)
In December 2019, Helocyte entered into a non-exclusive license agreement with the National Institute of Allergy and Infectious Disease (a division of the National Institutes of Health (“NIAID”)) for the use of certain material pertaining to one of its product candidates. Helocyte agreed to pay an upfront fee of $
For the year ended December 31, 2020 and 2019, Helocyte recorded
Mustang
For the years ended December 31, 2020 and 2019 Mustang recorded the following expense in research and development – licenses acquired:
For the Year Ended December 31, | ||||||
($ in thousands) |
| 2020 |
| 2019 | ||
City of Hope National Medical Center | ||||||
CD123 (MB-102)3 | $ | | $ | | ||
IL13Rα2 (MB-101) 3 | | | ||||
HER2 (MB-103)1 | | | ||||
CS1 (MB-104) | | | ||||
PSCA (MB-105)3 |
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Spacer | | | ||||
Fred Hutch - CD20 (MB-106)2 | | | ||||
Nationwide Children’s Hospital - C134 (MB-108) | | | ||||
CSL Behring (Calimmune) | | | ||||
UCLA | | | ||||
SIRION LentiBOOSTTM | | | ||||
Total | $ | | $ | |
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License Agreement with City of Hope
In March 2015, Mustang entered into an exclusive license agreement with COH to acquire intellectual property rights pertaining to chimeric antigen receptor (“CAR”) engineered T cell (“CAR T”) technologies (the “COH License”). Pursuant to the COH License, Mustang paid COH an upfront fee of $
In February 2017, the Company and COH amended and restated the COH License by entering into three separate amended and restated exclusive license agreements, one relating to CD123 (MB-102), one relating to IL13Rα2 (MB-101) and one relating to the Spacer technology, that amended the COH License in certain other respects, and collectively replace the COH License in its entirety. The total potential consideration payable to COH by the Company, in equity or cash, did not, in the aggregate, change materially from the COH License.
CD123 License with City of Hope (MB-102)
Pursuant to the CD123 License, Mustang and COH acknowledge that an upfront fee was paid under the COH License. In addition, an annual maintenance fee will continue to apply. COH is eligible to receive up to approximately $
Nationwide Children’s Hospital License Agreement (MB-108)
In February 2019, Mustang announced that it partnered and entered into an exclusive worldwide license agreement with Nationwide Children’s Hospital (“Nationwide”) to develop their C134 oncolytic virus (MB-108) for the treatment of glioblastoma multiforme (“GBM”). Mustang intends to combine MB-108 with MB-101 (IL13Rα2-specific CAR T) to potentially enhance efficacy in treating GBM. There were
CS1 License with City of Hope (MB-104)
On May 31, 2017, Mustang entered into an exclusive license agreement with the COH for the use of CS1-specific CAR T technology to be directed against multiple myeloma. Pursuant to the agreement, Mustang paid an upfront fee of $
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PSCA License with City of Hope (MB-105)
On May 31, 2017, Mustang entered into an exclusive license agreement with the COH for the use of prostate stem cell antigen (“PSCA”) CAR T technology to be used in the treatment of prostate cancer. Pursuant to the agreement, Mustang paid an upfront fee of $
CSL Behring (Calimmune) License (MB-107)
On August 23, 2019, Mustang entered into a non-exclusive license agreement with CSL Behring (Calimmune, Inc.) (“Calimmune License”) for the CytegrityTM stable producer cell line for the production of viral vector for Mustang’s lentiviral gene therapy program for the treatment of XSCID. Mustang had previously licensed the XSCID gene therapy program from St. Jude in August 2018. Mustang paid $
University of California License
On March 17, 2017, Mustang entered into an exclusive license agreement with the Regents of the University of California (“UCLA License”) to acquire intellectual property rights in patent applications related to the engineered anti-prostate stem cell antigen antibodies for cancer targeting and detection. Pursuant to the UCLA License, Mustang paid UCLA an upfront fee of $
HER2 License with City of Hope (MB-103)
On May 31, 2017, Mustang entered into an exclusive license agreement with the COH for the use of human epidermal growth factor receptor 2 (“HER2”) CAR T technology (“HER2 Technology”), which will be applied in the treatment of glioblastoma multiforme. Pursuant to the agreement, Mustang paid an upfront fee of $
St. Jude Children’s Research Hospital License (MB-107 and MB-207)
On August 2, 2018, Mustang entered into an exclusive worldwide license agreement with St. Jude for the development of a first-in-class ex vivo lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency (“XSCID”). Mustang paid $
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Manufacturing License with City of Hope
On January 3, 2018, Mustang entered into a non-exclusive license agreement with COH to acquire patent and licensed know-how rights related to developing, manufacturing, and commercializing licensed products. The Company paid $
IL13Rα2 License with City of Hope (MB-101)
Pursuant to the IL13Rα2 License, Mustang and COH acknowledge that an upfront fee was paid under the Original License. In addition, an annual maintenance fee will continue to apply. COH is eligible to receive up to approximately $
Spacer License with City of Hope
Pursuant to the Spacer License, Mustang and COH acknowledge that an upfront fee was paid under the Original License. In addition, an annual maintenance fee will continue to apply. No royalties are due if the Spacer technology is used in conjunction with a CD123 CAR or an IL13Rα2 CAR, and royalty payments in the low single digits are due on net sales of licensed products if the Spacer technology is used in conjunction with other intellectual property. Mustang is obligated to pay COH a percentage (in the mid-thirties) of certain revenues received in connection with a sublicense. In addition, equity grants made under the Original License were acknowledged, and the anti-dilution provisions of the Original License were carried forward. For the year ended December 31, 2020, Mustang expensed a non-refundable milestone payment of $
IV/ICV Agreement with City of Hope
On February 17, 2017, Mustang entered into an exclusive license agreement (the “IV/ICV Agreement”) with COH to acquire intellectual property rights in patent applications related to the intraventricular and intracerebroventricular methods of delivering T cells that express CARs. Pursuant to the IV/ICV Agreement, Mustang paid COH an upfront fee of $
Fred Hutchinson Cancer Research Center License (MB-106)
On July 3, 2017, Mustang entered into an exclusive, worldwide licensing agreement with Fred Hutchinson Cancer Research Center (“Fred Hutch”) for the use of a CAR T therapy related to autologous T cells engineered to express a CD20-specific chimeric antigen receptor (“CD20 Technology License”). Pursuant to the CD20 Technology License, Mustang paid Fred Hutch an upfront fee of $
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Harvard College License
On November 20, 2017, Mustang entered into an exclusive, worldwide license agreement with President and Fellows of Harvard College (the “Harvard Agreement”) for the use of gene editing, via the use of CRISPR/Cas9, to be used in enhancing the efficacy of chimeric antigen receptor T (CAR T) cell therapies for solid tumor indications and to generate universal off the shelf CAR T cell therapies for both liquid and solid tumor indications. Pursuant to the Harvard Agreement, Mustang paid Harvard College an upfront fee of $
Mustang terminated the Harvard Agreement in January 2020.
SIRION Biotech GmbH - LentiBOOSTTM (MB-207)
In October, 2020, Mustang announced a worldwide licensing agreement with SIRION Biotech (“SIRION”) for the rights to SIRION’s LentiBOOSTTM technology for the development of MB-207, Mustang’s lentiviral gene therapy for the treatment of previously transplanted patients with X-linked severe combined immunodeficiency (the “SIRION Technology License”). Pursuant to the SIRION Technology License, which requires payment in Euro, the Company paid SIRION a one-time upfront fee of $
For the year ended December 31, 2020, Mustang expensed an up-front payment of $
Oncogenuity
Effective May 6, 2020, Oncogenuity entered into a license agreement with the Trustees of Columbia University in the City of New York (“Columbia”) to develop novel oligonucleotides for the treatment of genetically driven cancers (the “Columbia License”). The proprietary platform produces oligomers, known as “ONCOlogues.”
As consideration for the Columbia License, Oncogenuity paid an upfront fee of $
Development milestone payments totaling up to approximately $
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For the year ended December 31, 2020, Oncogenuity recorded expense of $
Tamid
Licenses with the University of North Carolina
On November 30, 2017, Tamid entered into three exclusive AAV gene therapies licensing arrangements with the University of North Carolina at Chapel Hill (“UNC”). The preclinical product candidates acquired through these licenses target ocular manifestations of Mucopolysaccharidosis type 1 (MPS1), dysferlinopathies and corneal transplant rejections. The three therapies were developed in the lab of Matthew Hirsch, Ph.D., Assistant Professor, Ophthalmology at the UNC Gene Therapy center. In December 2019, Tamid discontinued the development of all three candidates and terminated the related licenses and clinical trial agreements with UNC. For the years ended December 31, 2020 and 2019, Tamid recorded
8. Sponsored Research and Clinical Trial Agreements
Aevitas
For the Year Ended December 31, | ||||||
($ in thousands) |
| 2020 |
| 2019 | ||
UMass - adeno-associated virus ("AAV") | $ | | $ | | ||
UPenn - AAV | | | ||||
Duke - AAV | | | ||||
Total | $ | | $ | |
On January 25, 2018, Aevitas entered into a Sponsored Research Agreement with the University of Massachusetts (“UMass SRA”) for certain continued research and development activities related to the development of adeno-associated virus (“AAV”) gene therapies in complement-mediated diseases. The total amount to be funded by Aevitas under the UMass SRA is $
On July 24, 2018, Aevitas entered into a Sponsored Research Agreement with the Trustees of the University of Pennsylvania (“UPenn SRA”) for certain continued research and development activities related to the development of AAV gene therapies in complement-mediated diseases. The total amount to be funded by Aevitas under the UPenn SRA is $
On September 1, 2019, Aevitas entered into a Sponsored Research Arrangement (“SRA”) with Duke University School of Medicine (“Duke”). For the years ended December 31, 2020 and 2019, Aevitas recorded approximately
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Cellvation
In October 2016, Cellvation entered research funding agreement with the University of Texas in connection with the license for a method and apparatus for conditioning cell populations for cell therapies. In connection with this agreement Cellvation agreed to fund $
Mustang
For the years ended December 31, 2020 and 2019 Mustang recorded the following expense in research and development for sponsored research and clinical trial agreements:
For the Year Ended December 31, | ||||||
($ in thousands) |
| 2020 |
| 2019 | ||
City of Hope National Medical Center | $ | | $ | | ||
CD123 (MB-102) |
| |
| | ||
IL13Rα2 (MB-101) |
| |
| | ||
Manufacturing |
| |
| | ||
CS1 (MB-104) | | | ||||
HER2 (MB-103) | | | ||||
PSCA (MB-105) | | | ||||
Beth Israel Deaconess Medical Center - CRISPR | | | ||||
St. Jude Children's Research Hospital - XSCID (MB-107) | | | ||||
Fred Hutchinson Cancer Research Center - CD20 (MB-106) | | | ||||
Total | $ | | $ | |
City of Hope Sponsored Research Agreement
In March 2015, in connection with Mustang’s license with COH for the development of CAR T, Mustang entered into a Sponsored Research Agreement in which Mustang will fund continued research in the amount of $
CD123 (MB-102) Clinical Research Support Agreement
On February 17, 2017, Mustang entered into a Clinical Research Support Agreement for CD123. Pursuant to the terms of this agreement, Mustang made an upfront payment of approximately $
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CS1(MB-104) Clinical Research Support Agreement
In June 2020, Mustang entered into a clinical research and support agreement with COH in connection with an Investigator-sponsored study conducted under an Institutional Review Board-approved, investigator-initiated protocol entitled: "Phase I Study to Evaluate Cellular Immunotherapy Using Memory-Enriched T Cells Lentivirally Transduced to Express a CS1-Targeting, Hinge-Optimized, 41BB-Costimulatory Chimeric Antigen Receptor and a Truncated EGFR Following Lymphodepleting Chemotherapy in Adult Patients with CS1+ Multiple Myeloma." The CAR T being studied under this protocol has been designated by Mustang as MB-104. Under the terms of the agreement Mustang will reimburse COH for costs associated with this trial not to exceed $
IL13Rα2 (MB-101) Clinical Research Support Agreements
On February 17, 2017, Mustang entered into a Clinical Research Support Agreement for IL13Rα2 (the “IL13Rα2 GBM CRA”). Pursuant to the terms of this agreement Mustang made an upfront payment of approximately $
In October 2020, Mustang entered into a Clinical Research Support Agreement for the IL13Rα2 directed CAR T program for adult patients with Leptomeningeal Glioblastoma, Ependymoma or Medulloblastoma (the “IL13Rα2 Leptomeningeal CRA”). Pursuant to the terms of the IL13Rα2 Leptomeningeal CRA, Mustang made an upfront payment of $
For the years ended December 31, 2020 and 2019, Mustang recorded approximately $
HER2 (MB-103) Clinical Research Support Agreement
In September 2020, Mustang entered into a clinical research support agreement with COH in connection with an Investigator-sponsored study conducted under an Institutional Review Board-approved, investigator-initiated protocol entitled: “Phase I Study of Cellular Immunotherapy using Memory-Enriched T Cells Lentivirally Transduced to Express a HER2-Specific, Hinge-Optimized, 41BB-Costimulatory Chimeric Receptor and a Truncated CD19 for Patients with Recurrent/Refractory Malignant Glioma.” The CAR T being studied under this protocol has been designated as MB-103. Under the terms of the agreement Mustang will pay COH $
PSCA (MB-105) Clinical Research Support Agreement
In October 2020, Mustang entered into a clinical research support agreement with COH in connection with an Investigator-sponsored study conducted under an Institutional Review Board-approved, investigator-initiated protocol entitled: “A Phase 1b study to evaluate PSCA-specific chimeric antigen receptor (CAR)-T cells for patients with metastatic castration resistant prostate cancer.” The CAR T being studied under this protocol has been designated as MB-105. Under the terms of the agreement Mustang will pay COH $
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City of Hope Sponsored Research Agreement - Manufacturing
On January 3, 2018, Mustang entered into a Sponsored Research Agreement (“SRA”) with COH to optimize and develop CAR T cell processing procedures. Pursuant to the SRA, Mustang funded continued research in the amount of $
CRISPR Sponsored Research Agreement with Beth Israel Deaconess Medical Center, Inc.
On November 28, 2017, Mustang entered into a Sponsored Research Agreement with Beth Israel Deaconess Medical Center Inc. (“BIDMC”) to perform research relating to gene editing, via the use of CRISPR/Cas9, to be used in enhancing the efficacy of CAR T cell therapies for solid tumor indications and to generate universal off the shelf CAR T cell therapies for both liquid and solid tumor indications. Mustang agreed to fund approximately $
CD20 (MB-106) Clinical Trial Agreement with Fred Hutch
On July 3, 2017, in conjunction with the CD20 Technology License from Fred Hutch, Mustang entered into an investigator-initiated clinical trial agreement (“CD20 CTA”) to provide partial funding for a Phase 1/2 clinical trial at Fred Hutch evaluating the safety and efficacy of the CD20 Technology in patients with relapsed or refractory B-cell non-Hodgkin lymphomas. In connection with the CD20 CTA, Mustang agreed to fund up to $
CD20 (MB-106) Sponsored Research Agreement – Manufacturing with Fred Hutch
On March 17, 2018, Mustang entered into a Sponsored Research Agreement (“SRA”) with Fred Hutch related to developing and optimizing processes and systems associated with CD20 cell processing. Pursuant to the SRA, Mustang funded research in the amount of $
XSCID (MB-107) Data Transfer Agreement with St. Jude
In June 2020, Mustang entered into a Data Transfer Agreement with St. Jude under which Mustang will reimburse St. Jude for costs associated with St. Jude’s clinical trial for the treatment of infants with XSCID. Pursuant to the terms of this agreement and for the year ended December 31, 2020, Mustang paid an upfront fee of $
MB-107 (XSCID) Non-Interventional Services Agreement with Children’s CGMP
In December 2019, Mustang entered into a Non-Interventional Services Agreement with Children's CGMP, LLC ("Children’s"), an affiliate of St. Jude Children's Research Hospital, pursuant to which Children’s provides lentiviral vector for non-clinical XSCID research purposes, as well as related advisory services. Mustang agreed to fund approximately $
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Oncogenuity
Columbia Sponsored Research Agreement
Pursuant to the terms of the Columbia License, Oncogenuity will make semi-annual research payments to Columbia over a
University of Oxford Sponsorship Agreement
On December 16, 2020 Oncogenuity entered into an agreement with The Chancellor Masters and Scholars of the University of Oxford (“Oxford”). Under the terms of the agreement Oxford will engage in preclinical development of antisense oligonulcleotides as a therapy in certain indications. In connection with the agreement Oncogenuity agreed to fund research for approximately
Tamid
On November 30, 2017, in connection with its three separate license agreements with UNC, Tamid entered into a Sponsored Research Agreement with UNC (“UNC SRA”) for certain continued research and development activities related to Nanodysferlin for treatment of Dysferlinopathy, and AAV-HLA-G for corneal transplant rejection. Total amount to be funded by Tamid under the UNC SRA is $
9. Intangibles
On December 18, 2020, Journey entered an Asset Purchase Agreement with a third party (the “Anti-itch Product Agreement”) for a topical product that is indicated to treat scabies and skin itch conditions (“Anti-itch Product”). Pursuant to the terms and conditions of the Anti-itch Product Agreement, Journey agreed to pay $
The Company, in accordance with ASU 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business, determined the purchase of the Anti-itch Product did not constitute the purchase of a business, and therefore recorded the purchase price of the Anti-itch Product as an asset, to be amortized over the life of the product, which is deemed to be
On July 29, 2020, Journey entered into a License and Supply Agreement with a third party to acquire intellectual property rights to an oral acne product that is indicated for the treatment of severe acne (the “Isotretinoin Agreement”). Pursuant to the terms and conditions of the Isotretinoin Agreement, Journey agreed to pay $
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The Company, in accordance with ASU 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business, determined the purchase of the Isotretinoin Agreement did not constitute the purchase of a business, and therefore recorded the purchase price of the Isotretinoin Agreement as an asset, to be amortized over the life of the product, which is deemed to be
On July 22, 2019 Journey purchased Ximino®, a minocycline hydrochloride used to treat acne from a third party. Pursuant to the terms and conditions of the Asset Purchase Agreement (“APA”), total consideration for the APA is $
The Company, in accordance with ASU 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business, determined the purchase of Ximino did not constitute the purchase of a business, and therefore recorded the purchase price of Ximino as an asset, to be amortized over the life of the product, which is deemed to be
In accordance with the terms of the APA Journey will incur interest expense in the event of payment default. As such per ASC 835-30 Interest-Imputed Interest, Journey recorded an initial discount for imputed interest of $
On August 31, 2018, JMC entered into an agreement with a third party to acquire the exclusive rights to Exelderm®, a topical antifungal available in a cream and solution. This acquisition was recorded as an intangible asset and expense will be recognized over the expected life of Exelderm® of
In January 2016, JMC entered into a licensing agreement with a third party to distribute its prescription wound cream Luxamend ® and paid an upfront fee of $
In March 2015, JMC entered into a license and supply agreement to acquire the rights to distribute Targadox® a dermatological product for the treatment of acne. JMC made an upfront payment of $
The table below provides a summary of intangible assets as of December 31, 2020 and 2019, respectively:
Estimated Useful | ||||||||
($ in thousands) |
| Lives (Years) |
| December 31, 2020 |
| December 31, 2019 | ||
Total Intangible assets – asset purchases | $ | | $ | | ||||
Accumulated amortization |
|
|
| ( |
| ( | ||
Net intangible assets |
|
| $ | | $ | |
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The table below provides a summary for the years ended December 31, 2020 and 2019, of recognized expense related to product licenses, which was recorded in costs of goods sold on the Consolidated Statement of Operations (see Note 19):
Intangible | |||
($ in thousands) |
| Assets, Net | |
Beginning balance at December 31, 2018 | $ | | |
Additions: | |||
Purchase of Ximino1 | | ||
Amortization expense | ( | ||
Beginning balance at December 31, 2019 | | ||
Additions: | |||
Isotretinoin Agreement2 | | ||
Anti-itch product license acquisition3 | | ||
Amortization expense |
| ( | |
Ending balance at December 31, 2020 | $ | |
Note 1: Includes an upfront payment of $
Note 2: Includes an upfront payment of $
Note 3: Includes an upfront payment of $
The future amortization of these intangible assets is as follows:
Total | |||||||||
($ in thousands) |
| Ximino® |
| Exelderm® |
| Amortization | |||
Year Ended December 31, 2021 | $ | | $ | | $ | | |||
Year Ended December 31, 2022 |
| |
| |
| | |||
Year Ended December 31, 2023 | | | | ||||||
Year Ended December 31, 2024 | | | | ||||||
Year Ended December 31, 2025 |
| |
| |
| | |||
Thereafter | | | | ||||||
Sub-total | | | | ||||||
Intangible assets not yet placed in service | — | | | ||||||
Total | $ | | $ | | $ | |
F-43
10. Debt and Interest
Debt
Total debt consists of the following:
| December 31, |
|
| |||||||
($ in thousands) | 2020 | 2019 | Interest rate | Maturity | ||||||
IDB Note | $ | | $ | |
| | % | |||
2017 Subordinated Note Financing3 |
| |
| |
| | % | |||
2017 Subordinated Note Financing3 |
| |
| |
| | % | |||
2017 Subordinated Note Financing3 |
| |
| |
| | % | |||
2017 Subordinated Note Financing3 |
| |
| |
| | % | |||
2017 Subordinated Note Financing3 |
| |
| |
| | % | |||
2018 Venture Notes4 |
| |
| |
| | % | |||
2018 Venture Notes4 |
| |
| |
| | % | |||
2019 Notes1 |
| |
| |
| | % | |||
Mustang Horizon Notes2 |
| |
| |
| | % | |||
Oaktree Note | | | | % | ||||||
Total notes payable |
| |
| |
|
|
|
| ||
Less: Discount on notes payable |
| |
| |
|
|
|
| ||
Total notes payable | $ | | $ | |
|
|
|
|
Note 1: Formerly the Opus Credit Facility (see Note 17).
Note 2: Interest rate is
Note 3: As a result of a one year maturity date extension, the interest rate of
Note 4: At December 31, 2019, $
Oaktree Note
On August 27, 2020 (the “Closing Date”), Fortress, as borrower, entered into a $
The Oaktree Note bears interest at a fixed annual rate of
The Oaktree Agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among other things, restrictions on indebtedness, liens, affiliate transactions, investments, acquisitions, mergers, dispositions, prepayment of permitted indebtedness, and dividends and other distributions, subject to certain exceptions. These affirmative and negative covenants apply in different instances to Fortress itself, its private subsidiaries, its public subsidiaries, or certain combinations of the foregoing. The limitations on dividends and other distributions have the practical effect of preventing any further issuances by the Company or its private subsidiaries of equity securities with cash dividends or redemption features.
F-44
In addition, the Oaktree Agreement contains certain financial covenants, including, among other things, (i) maintenance of minimum liquidity and (ii) a minimum revenue test that requires Journey’s annual revenue to be equal to or to exceed annual revenue projections set forth in the agreement. Failure by the Company or Journey, as applicable, to comply with the financial covenants will result in an event of default, subject to certain cure rights of the Company. The Company was in compliance with all applicable covenants under the Oaktree Note as of December 31, 2020.
The Oaktree Agreement contains customary events of default, in certain circumstances subject to customary cure periods. These events of default apply in different instances to Fortress itself, its private subsidiaries, its public subsidiaries, or a certain combination of the foregoing. 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 Oaktree Agreement, in addition to other remedies available to the lenders as secured creditors of the Company.
The Oaktree Agreement grants a security interest in favor of the Agent, for the benefit of the lenders, in substantially all of the Company’s assets (consisting principally of the Company’s shareholdings in, and in some cases debt owing from, its partner companies) as collateral securing the Company’s obligations under the Oaktree Agreement, except for: (i) certain interests in controlled foreign corporation subsidiaries of the Company; (ii) the Company’s holdings in Avenue; and (iii) those portions of the Company’s holdings in certain subsidiaries (plus Caelum) that are encumbered by pre-existing equity pledges to certain of the Company’s officers. None of Fortress’ subsidiaries or partner companies is a party to the Oaktree Agreement, and the collateral package does not include the asets of any such subsidiaries or partner companies.
Pursuant to the terms of the Oaktree Agreement, on the Closing Date the Company paid Oaktree an upfront commitment fee equal to
In connection with the Oaktree Note, the Company issued warrants to Oaktree and certain of its affiliates to purchase up to
As of December 31, 2020, the Company recorded the fees totaling $
IDB Note
On February 13, 2014, the Company executed a promissory note in favor of IDB in the amount of $
The obligations of the Company under the IDB Note were collateralized by a security interest in, a general lien upon, and a right of set-off against the Company’s money market account of $
F-45
The Company could default on the IDB Note if, among other things, it failed to pay outstanding principal or interest when due. Following the occurrence of an event of default under the IDB Note, the Bank may: (i) declare the entire outstanding principal balance of the IDB Note, together with all accrued interest and other sums due under the IDB Note, to be immediately due and payable; (ii) exercise its right of setoff against any money, funds, credits or other property of any nature in possession of, under control or custody of, or on deposit with IDB; (iii) terminate the commitments of IDB; and (iv) liquidate the money market account to reduce the Company’s obligations to IDB.
On September 18, 2017, the maturity on the IDB Note was extended to
During August 2020, the Company repaid the IDB Note utilizing the cash collateral securing the IDB Note, which was classified as restricted cash on the Company’s Consolidated Balance Sheet.
At December 31, 2020 and 2019, the Company had approximately
2019 Notes (formerly the Opus Credit Facility)
On September 14, 2016, Fortress entered into a Credit Facility Agreement (the “Opus Credit Facility”) with Opus Point Healthcare Innovations Fund, LP (“OPHIF”). Since Fortress’s Chairman, President and Chief Executive Officer (Lindsay A. Rosenwald) and Fortress’s Executive Vice President, Strategic Development (Michael S. Weiss), are Co-Portfolio Managers and Partners of Opus Point Partners Management, LLC (“Opus”), an affiliate of OPHIF, all of the disinterested directors of Fortress’s board of directors approved the terms of the Credit Facility Agreement and accompanying Pledge and Security Agreement and forms of Note and Warrant (collectively, the “Financing Documents”).
Pursuant to the Opus Credit Facility, Fortress was eligible to borrow up to a maximum aggregate amount of $
Pursuant to the Opus Credit Facility and form of Note, each Note will bear interest at
Fortress may terminate the Opus Credit Facility upon notice to the Lenders and payment of all outstanding obligations under the Credit Facility Agreement. Notwithstanding any early termination of the Credit Facility Agreement, within 15 days after termination of the Commitment Period, Fortress will issue each Lender warrants (each a “Warrant”) pursuant to the terms of the Credit Facility Agreement and form of Warrant to purchase their pro rata share of (a)
F-46
On March 12, 2018, the Company and OPHIF amended and restated the Opus Credit Facility (the “A&R Opus Credit Facility”). The A&R Opus Credit Facility extended the maturity date of the notes issued under the Opus Credit Facility from
On July 18, 2019, Fortress issued
Effective December 31, 2019, OPHIF dissolved and distributed it assets among its limited partners. Following the distribution, the $
In August, 2020, the Company used certain proceeds from the Oaktree Note to pay off the $
IDB Letters of Credit
The Company has several letters of credit (“LOC”) with IDB securing rent deposits for lease facilities totaling approximately $
2017 Subordinated Note Financing
On March 31, 2017, the Company entered into Note Purchase Agreements (the “Purchase Agreements”) with NAM Biotech Fund II, LLC I (“NAM Biotech Fund”) and NAM Special Situations Fund I QP, LLC (“NAM Special Situations Fund”), both of which are accredited investors, and sold subordinated promissory notes (the “Notes”) of the Company (the “2017 Subordinated Note Financing”) in the aggregate principal amount of $
F-47
National Securities Corporation (“NSC”), a subsidiary of National and a related party, (see Note 17), pursuant to a Placement Agency Agreement entered into between the Company, NAM Biotech Fund and NSC (the “NAM Placement Agency Agreement”) and a Placement Agency Agreement entered into between the Company, NAM Special Situations Fund and NSC (together with the NAM Placement Agency Agreement, the “Placement Agency Agreements”) acts as placement agent in the 2017 Subordinated Note Financing. Pursuant to the terms of the Placement Agency Agreements, NSC receives (in addition to reimbursement of certain expenses) an aggregate cash fee equal to
On March 31, 2017, the Company held its first closing of the 2017 Subordinated Note Financing and received gross proceeds of $
On May 1, 2017, the Company held a second closing of the 2017 Subordinated Note Financing and received gross proceeds of $
On May 31, 2017, the Company held a third closing of the 2017 Subordinated Note Financing and received gross proceeds of $
On June 30, 2017, the Company held a fourth closing of the 2017 Subordinated Note Financing and received gross proceeds of $
On August 31, 2017, the Company held a fifth closing of the 2017 Subordinated Note Financing and received gross proceeds of $
On September 30, 2017, the Company held a sixth closing of the 2017 Subordinated Note Financing and received gross proceeds of $
In August, 2020, the Company used certain proceeds from the Oaktree Note to pay off the $
2018 Venture Notes
During the year ended December 31, 2018, the Company closed a private placement of promissory notes for an aggregate of $
F-48
NSC acted as the sole placement agent for the 2018 Venture Notes. The Company paid NSC a fee of $
The 2018 Venture Notes allows the Company to transfer a portion of the proceeds from the 2018 Venture Notes to a Fortress subsidiary upon the completion by such subsidiary of an initial public offering in which it raises sufficient equity capital so that it has cash equal to five times the amount of the portion of the proceeds of the 2018 Venture Notes so transferred (the “SubCo Funding Threshold”).
Through December 31, 2019, the Company had transferred $
In connection with this transfer NSC received warrants to purchase each such subsidiary’s stock equal to
In August, 2020, the Company used certain proceeds from the Oaktree Note to pay off the $
Mustang Horizon Notes
On March 29, 2019 (the "Closing Date"), Mustang entered into a $
Each advance under the Mustang Horizon Notes will mature
Each advance of the loan is secured by a lien on substantially all of the assets of Mustang, other than Intellectual Property and Excluded Collateral (in each case as defined in the Loan Agreement), and contains customary covenants and representations, including a liquidity covenant, financial reporting covenant and limitations on dividends, indebtedness, collateral, investments, distributions, transfers, mergers or acquisitions, taxes, corporate changes, deposit accounts, and subsidiaries.
F-49
The events of default under the Loan Agreement include, among other things, without limitation, and subject to customary grace periods, (1) Mustang's failure to make any payments of principal or interest under the Loan Agreement, promissory notes or other loan documents, (2) the Mustang's breach or default in the performance of any covenant under the Loan Agreement, (3) the occurrence of a material adverse change, (4) Mustang making a false or misleading representation or warranty in any material respect, (5) the Mustang's insolvency or bankruptcy, (6) certain attachments or judgments on the Mustang's assets, (7) the occurrence of any material default under certain agreements or obligations of Mustang involving indebtedness in excess of $
The Loan Agreement also contains warrant coverage of
Mustang paid Horizon an initial commitment fee of $
All fees, warrants and costs paid to Horizon and all direct costs incurred by Mustang are recognized as a debt discount to the funded loans and are amortized to interest expense using the effective interest method over the term of the Loan Agreement.
On September 30, 2020, Mustang repaid the amount outstanding under the Horizon Notes in full, which was comprised of $
Interest Expense
The following table shows the details of interest expense for all debt arrangements during the periods presented. Interest expense includes contractual interest and amortization of the debt discount and amortization of fees represents fees associated with loan transaction costs, amortized over the life of the loan:
Year Ended December 31, | ||||||||||||||||||
2020 | 2019 | |||||||||||||||||
($ in thousands) |
| Interest |
| Fees |
| Total |
| Interest |
| Fees |
| Total | ||||||
IDB Note | $ | | $ | | $ | | $ | | $ | - | $ | | ||||||
2017 Subordinated Note Financing1 |
| |
| |
| |
| |
| |
| | ||||||
2019 Notes |
| |
| |
| |
| | |
| | |||||||
2018 Venture Notes1 |
| |
| |
| |
| |
| |
| | ||||||
LOC Fees |
| |
| |
| |
| |
| |
| | ||||||
Mustang Horizon Notes1,3 |
| |
| |
| |
| |
| |
| | ||||||
Oaktree Note1 | | | | | | | ||||||||||||
Note Payable2 | | | | | | | ||||||||||||
Other |
| ( |
| |
| ( |
| | | | ||||||||
Total Interest Expense and Financing Fee | $ | | $ | | $ | | $ | | $ | | $ | |
Note 1:For the year ended December 31, 2020, includes $ |
Note 2: Imputed interest expense related to Ximino purchase (see Note 9).
Note 3: Includes $
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11. Accrued Liabilities and other Long-Term Liabilities
Accrued expenses and other long-term liabilities consisted of the following:
December 31, | ||||||
($ in thousands) |
| 2020 |
| 2019 | ||
Accrued expenses: |
|
|
|
| ||
Professional fees | $ | | $ | | ||
Salaries, bonus and related benefits |
| |
| | ||
Research and development |
| |
| | ||
Research and development - manufacturing |
| |
| | ||
Research and development - license maintenance fees |
| |
| | ||
Research and development - milestones |
| |
| | ||
Accrued royalties payable |
| |
| | ||
Accrued coupon funding expense |
| |
| | ||
Other |
| |
| | ||
Total accrued expenses | $ | | $ | | ||
Other long-term liabilities: |
|
|
|
| ||
Deferred rent and long-term lease abandonment charge1 | $ | | $ | | ||
Partner company note payable, long-term | ||||||
Ximino agreement2 | | | ||||
Isotretinoin agreement3 | | | ||||
Anti-itch product agreement4 | | | ||||
Total other long-term liabilities and partner company note payable, long-term | $ | | $ | |
Note 1: Balance consists of deferred charges related to build-out of the New York facility
Note 2: As of December 31, 2019, Journey recorded a note payable, net of an imputed interest discount of $
Note 3: As of December 31, 2020, Journey recorded a note payable, net of an imputed interest discount of $
Note 4: As of December 31, 2020, Journey recorded a note payable, net of an imputed interest discount of $
F-51
12. Non-Controlling Interests
Non-controlling interests in consolidated entities are as follows:
|
| For the year ended |
|
|
|
|
| |||||
As of December 31, 2020 | December 31, 2020 | As of December 31, 2020 |
| |||||||||
Net loss attributable to | Non-controlling interests | Non-controlling |
| |||||||||
($ in thousands) |
| NCI equity share | non-controlling interests | in consolidated entities | ownership |
| ||||||
Acquisition Corp VIII | $ | ( | $ | ( | $ | ( |
| | % | |||
Aevitas | ( |
| ( |
| ( |
| | % | ||||
Avenue 2 |
| |
| ( |
| |
| | % | |||
Baergic |
| ( |
| ( |
| ( |
| | % | |||
Cellvation |
| ( |
| ( |
| ( |
| | % | |||
Checkpoint 1 |
| |
| ( |
| |
| | % | |||
Coronado SO |
| ( |
| |
| ( |
| | % | |||
Cyprium |
| |
| ( |
| ( |
| | % | |||
Helocyte |
| ( |
| ( |
| ( |
| | % | |||
JMC |
| |
| |
| |
| | % | |||
Mustang 2 |
| |
| ( |
| |
| | % | |||
Oncogenuity | ( |
| ( |
| ( |
| | % | ||||
Tamid |
| ( |
| ( |
| ( |
| | % | |||
Total | $ | | $ | ( | $ | |
|
|
| For the year ended |
|
|
| ||||||||
As of December 31, 2019 | December 31, 2019 | As of December 31, 2019 |
| |||||||||
Net loss attributable to | Non-controlling interests | Non-controlling |
| |||||||||
($ in thousands) |
| NCI equity share |
| non-controlling interests |
| in consolidated entities |
| ownership |
| |||
Aevitas | $ | ( | $ | ( | $ | ( |
| | % | |||
Avenue 2 |
| |
| ( |
| |
| | % | |||
Baergic |
| |
| ( |
| ( |
| | % | |||
Cellvation |
| ( |
| ( |
| ( |
| | % | |||
Checkpoint 1 |
| |
| ( |
| |
| | % | |||
Coronado SO |
| ( |
| |
| ( |
| | % | |||
Cyprium |
| ( |
| ( |
| ( |
| | % | |||
Helocyte |
| ( |
| ( |
| ( |
| | % | |||
JMC |
| ( |
| |
| |
| | % | |||
Mustang 2 |
| |
| ( |
| |
| | % | |||
Tamid |
| ( |
| ( |
| ( |
| | % | |||
Total | $ | | $ | ( | $ | |
|
|
Note 1: Checkpoint is consolidated with Fortress’ operations because Fortress maintains voting control through its ownership of Checkpoint’s Class A Common Shares which provide super-majority voting rights.
Note 2: Avenue and Mustang are consolidated with Fortress’ operations because Fortress maintains voting control through its ownership of Preferred Class A Shares which provide super-majority voting rights.
13. Net Loss per Common Share
Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of Common Stock outstanding during the period, without consideration for Common Stock equivalents. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of Common Stock and Common Stock equivalents outstanding for the period.
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The following shares of potentially dilutive securities, weighted during the years ended December 31, 2020 and 2019 have been excluded from the computations of diluted weighted average shares outstanding as the effect of including such securities would be antidilutive:
Year Ended December 31, | ||||
2020 |
| 2019 | ||
Warrants to purchase Common Stock |
| |
| |
Options to purchase Common Stock |
| |
| |
Convertible preferred stock |
| |
| |
Unvested Restricted Stock |
| |
| |
Unvested Restricted Stock Units |
| |
| |
Total |
| |
| |
14. Stockholders’ Equity
Common Stock
At the Company’s 2020 Annual Meeting of Stockholders held on June 17, 2020, its stockholders approved an amendment to its certificate of incorporation to increase the number of authorized shares of common stock available to issue by
The terms, rights, preference and privileges of the Common Stock are as follows:
Voting Rights
Each holder of Common Stock is entitled to one vote per share of Common Stock held on all matters submitted to a vote of the stockholders,f including the election of directors. The Company’s certificate of incorporation and bylaws do not provide for cumulative voting rights.
Dividends
Subject to preferences that may be applicable to any then outstanding preferred stock, the holders of the Company’s outstanding shares of Common Stock are entitled to receive dividends, if any, as may be declared from time to time by the Company’s Board of Directors out of legally available funds.
Liquidation
In the event of the Company’s liquidation, dissolution or winding up, holders of Common Stock will be entitled to share ratably in the net assets legally available for distribution to stockholders after the payment of all of the Company’s debts and other liabilities, subject to the satisfaction of any liquidation preference granted to the holders of any outstanding shares of Preferred Stock.
Rights and Preference
Holders of the Company’s Common Stock have no preemptive, conversion or subscription rights, and there is no redemption or sinking fund provisions applicable to the Common Stock. The rights, preferences and privileges of the holders of Common Stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of the Company’s preferred stock that are or may be issued.
Fully Paid and Nonassessable
All of the Company’s outstanding shares of Common Stock are fully paid and nonassessable.
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Series A Preferred Stock
On October 26, 2017, the Company designated
The terms, rights, preference and privileges of the Series A Preferred Stock are as follows:
Voting Rights
Except as may be otherwise required by law, the voting rights of the holders of the Series A Preferred Stock are limited to the affirmative vote or consent of the holders of at least two-thirds of the votes entitled to be cast by the holders of the Series A Preferred Stock outstanding at the time in connection with the: (1) authorization or creation, or increase in the authorized or issued amount of, any class or series of capital stock ranking senior to the Series A Preferred Stock with respect to payment of dividends or the distribution of assets upon liquidation, dissolution or winding up or reclassification of any of the Company’s authorized capital stock into such shares, or creation, authorization or issuance of any obligation or security convertible into or evidencing the right to purchase any such shares; or (2) amendment, alteration, repeal or replacement of the Company’s certificate of incorporation, including by way of a merger, consolidation or otherwise in which the Company may or may not be the surviving entity, so as to materially and adversely affect and deprive holders of Series A Preferred Stock of any right, preference, privilege or voting power of the Series A Preferred Stock.
Dividends
Dividends on Series A Preferred Stock accrue daily and will be cumulative from, and including, the date of original issue and shall be payable monthly at the rate of
No Maturity Date or Mandatory Redemption
The Series A Preferred Stock has no maturity date, and the Company is not required to redeem the Series A Preferred Stock. Accordingly, the Series A Preferred Stock will remain outstanding indefinitely unless the Company decides to redeem it pursuant to its optional redemption right or its special optional redemption right in connection with a Change of Control (as defined below), or under the circumstances set forth below under “Limited Conversion Rights Upon a Change of Control” and elect to convert such Series A Preferred Stock. The Company is not required to set aside funds to redeem the Series A Preferred Stock.
Optional Redemption
The Series A Preferred Stock
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Special Optional Redemption
Upon the occurrence a Change of Control (as defined below), the Company may redeem the shares of Series A Preferred Stock, at its option, in whole or in part, within one hundred twenty (120) days of any such Change of Control, for cash at $
A “Change of Control” is deemed to occur when, after the original issuance of the Series A Preferred Stock, the following have occurred and are continuing:
● | the acquisition by any person, including any syndicate or group deemed to be a “person” under Section 13(d)(3) of the Exchange Act of beneficial ownership, directly or indirectly, through a purchase, merger or other acquisition transaction or series of purchases, mergers or other acquisition transactions of the Company’s stock entitling that person to exercise more than 50% of the total voting power of all the Company’s stock entitled to vote generally in the election of the Company’s directors (except that such person will be deemed to have beneficial ownership of all securities that such person has the right to acquire, whether such right is currently exercisable or is exercisable only upon the occurrence of a subsequent condition); and |
● | following the closing of any transaction referred to in the bullet point above, neither the Company nor the acquiring or surviving entity has a class of common equity securities (or American Depositary Receipts representing such securities) listed on the NYSE, the NYSE American LLC or the Nasdaq Stock Market, or listed or quoted on an exchange or quotation system that is a successor to the NYSE, the NYSE American LLC or the Nasdaq Stock Market. |
Conversion, Exchange and Preemptive Rights
Except as described below under “Limited Conversion Rights upon a Change of Control,” the Series A Preferred Stock is not subject to preemptive rights or convertible into or exchangeable for any other securities or property at the option of the holder.
Limited Conversion Rights upon a Change of Control
Upon the occurrence of a Change of Control, each holder of shares of Series A Preferred Stock will have the right (unless, prior to the Change of Control Conversion Date, the Company has provided or provides irrevocable notice of its election to redeem the Series A Preferred Stock as described above under “Optional Redemption,” or “Special Optional Redemption”) to convert some or all of the shares of Series A Preferred Stock held by such holder on the Change of Control Conversion Date, into the Common Stock Conversion Consideration, which is equal to the lesser of:
● | the quotient obtained by dividing (i) the sum of the $ |
● |
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In the case of a Change of Control pursuant to which the Company’s common stock will be converted into cash, securities or other property or assets, a holder of Series A Preferred Stock will receive upon conversion of such Series A Preferred Stock the kind and amount of Alternative Form Consideration which such holder would have owned or been entitled to receive upon the Change of Control had such holder held a number of shares of the Company’s common stock equal to the Common Stock Conversion Consideration immediately prior to the effective time of the Change of Control.
Notwithstanding the foregoing, the holders of shares of Series A Preferred Stock will not have the Change of Control Conversion Right if the acquiror has shares listed or quoted on the NYSE, the NYSE American LLC or Nasdaq Stock Market or listed or quoted on an exchange or quotation system that is a successor to the NYSE, the NYSE American LLC or Nasdaq Stock Market, and the Series A Preferred Stock becomes convertible into or exchangeable for such acquiror’s listed shares upon a subsequent Change of Control of the acquiror.
Liquidation Preference
In the event the Company liquidates, dissolves or is wound up, holders of the Series A Preferred Stock will have the right to receive $
Ranking
The Series A Preferred Stock will rank, with respect to rights to the payment of dividends and the distribution of assets upon the Company’s liquidation, dissolution or winding up, (1) senior to all classes or series of the Company’s common stock and to all other equity securities issued by the Company other than equity securities referred to in clauses (2) and (3); (2) on a par with all equity securities issued by the Company with terms specifically providing that those equity securities rank on a par with the Series A Preferred Stock with respect to rights to the payment of dividends and the distribution of assets upon the Company’s liquidation, dissolution or winding up; (3) junior to all equity securities issued by the Company with terms specifically providing that those equity securities rank senior to the Series A Preferred Stock with respect to rights to the payment of dividends and the distribution of assets upon the Company liquidation, dissolution or winding up; and (4) junior to all of the Company’s existing and future indebtedness.
Stock-Based Compensation
As of December 31, 2020, the Company had four equity compensation plans: the Fortress Biotech, Inc. 2007 Stock Incentive Plan (the “2007 Plan”), 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 2007, the Company’s Board of Directors adopted and stockholders approved the 2007 Plan authorizing the Company to grant up to
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Certain partner companies have their own equity compensation plan under which shares are granted to eligible employees, directors and consultants in the form of restricted stock, stock options, and other types of grants of stock of the respective partner company’s common stock. The table below provides a summary of those plans as of December 31, 2020:
Partner | Shares | Shares available at | ||||
Company |
| Stock Plan |
| Authorized |
| December 31, 2020 |
Aevitas | Aevitas Therapeutics, Inc. 2018 Long Term Incentive Plan | | | |||
Avenue |
| Avenue Therapeutics, Inc. 2015 Stock Plan |
| |
| |
Baergic |
| FBIO Acquisition Corp. III 2017 Incentive Plan |
| |
| |
Cellvation |
| Cellvation Inc. 2016 Incentive Plan |
| |
| |
Checkpoint |
| Checkpoint Therapeutics, Inc. Amended and Restated 2015 Stock Plan |
| |
| |
Cyprium |
| Cyprium Therapeutics, Inc. 2017 Stock Plan |
| |
| |
Helocyte |
| DiaVax Biosciences, Inc. 2015 Incentive Plan |
| |
| |
Journey |
| Journey Medical Corporation 2015 Stock Plan |
| |
| |
Mustang |
| Mustang Bio, Inc. 2016 Incentive Plan |
| |
| |
Oncogenuity, Inc. | FBIO Acquisition Corp. VII 2017 Incentive Plan | | | |||
Tamid |
| FBIO Acquisition Corp. V 2017 Incentive Plan |
| |
| |
The purpose of the Company’s and partner company’s equity compensation plans is to provide for equity awards as part of an overall compensation package of performance-based rewards to attract and retain qualified personnel. Such awards include, without limitation, options, stock appreciation rights, sales or bonuses of restricted stock, restricted stock units or dividend equivalent rights, and an award may consist of one such security or benefit, or two or more of them in any combination or alternative. Vesting of awards may be based upon the passage of time, the occurrence of one or more events, or the satisfaction of performance criteria or other conditions.
Incentive and non-statutory stock options are granted pursuant to option agreements adopted by the plan administrator. Options generally have
The Company estimates the fair value of stock option grants using a Black-Scholes option pricing model. In applying this model, the Company uses the following assumptions:
● | Risk-Free Interest Rate: The risk-free interest rate is based on the yields of United States Treasury securities with maturities similar to the expected term of the options for each option group. |
● | Volatility: The Company utilizes the trading history of its Common Stock to determine the expected stock price volatility for its Common Stock. |
● | Expected Term: Due to the limited exercise history of the Company’s stock options, the Company determined the expected term based on the Simplified Method under SAB 107 and the expected term for non-employees is the remaining contractual life for both options and warrants. |
● | Expected Dividend Rate: The Company has not paid and does not anticipate paying any cash dividends in the near future on its common stock. |
The fair value of each option award was estimated on the grant date using the Black-Scholes option-pricing model and expensed under the straight-line method.
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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 years ended December 31, 2020 and 2019
Year Ended December 31, | ||||||
($ in thousands) |
| 2020 |
| 2019 | ||
Employee awards | $ | | $ | | ||
Executive awards of Fortress Companies' stock |
| |
| | ||
Non-employee awards |
| |
| | ||
Warrants | | | ||||
Partner Companies: | ||||||
Avenue |
| |
| | ||
Checkpoint |
| |
| | ||
Mustang |
| |
| | ||
Other |
| |
| | ||
Total stock-based compensation expense | $ | | $ | |
For the years ended 2020 and 2019, $
Options
The following table summarizes Fortress stock option activities excluding activities related to partner companies:
Weighted average | ||||||||||
Total | remaining | |||||||||
Weighted average | weighted average | contractual life | ||||||||
| Shares |
| exercise price |
| intrinsic value |
| (years) | |||
Options vested and expected to vest at December 31, 2018 | | $ | | $ | — | |||||
Granted | | | | |||||||
Options vested and expected to vest at December 31, 2019 |
| | $ | | $ | |
| |||
Exercised |
| ( | |
| — |
| — | |||
Forfeited | ( | | — | — | ||||||
Options vested and expected to vest at December 31, 2020 |
| | $ | | $ | |
|
During the years ended December 31, 2020 and 2019, there were no exercises of stock options.
As of December 31, 2020, the Company had
Restricted Stock
Stock-based compensation expense from restricted stock awards and restricted stock units for the years ended December 31, 2020 and 2019 was $
During 2020, the Company granted
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During 2019, the Company granted
The following table summarizes Fortress restricted stock awards and restricted stock units activities, excluding activities related to Fortress subsidiaries:
|
| Weighted | |||
average grant | |||||
Number of shares | price | ||||
Unvested balance at December 31, 2018 |
| | $ | | |
Restricted stock granted |
| |
| | |
Restricted stock vested |
| ( |
| | |
Restricted stock units granted | | | |||
Restricted stock units forfeited |
| ( |
| | |
Restricted stock units vested |
| ( |
| | |
Unvested balance at December 31, 2019 | | $ | | ||
Restricted stock granted | | | |||
Restricted stock vested | ( | | |||
Restricted stock units granted | | | |||
Restricted stock units forfeited | ( | | |||
Restricted stock units vested | ( | | |||
Unvested balance at December 31, 2020 | | $ | |
The total fair value of restricted stock units and awards that vested during the years ended December 31, 2020 and 2019 was $
Deferred Compensation Plan
On March 12, 2015, the Company’s Compensation Committee approved the Deferred Compensation Plan allowing all non-employee directors the opportunity to defer all or a portion of their fees or compensation, including restricted stock and restricted stock units. During the year ended December 31, 2020 and 2019, certain non-employee directors elected to defer an aggregate of
Employee Stock Purchase Plan
Eligible employees can purchase the Company’s Common Stock at the end of a predetermined offering period at
As of December 31, 2020,
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Warrants
The following table summarizes Fortress warrant activities, excluding activities related to partner companies:
Total weighted | Weighted average | |||||||||
average | remaining | |||||||||
Number of | Weighted average | intrinsic | contractual life | |||||||
| shares |
| exercise price |
| value |
| (years) | |||
Outstanding as of December 31, 2018 |
| | $ | | $ | | ||||
Granted | | | | — | ||||||
Forfeited | ( |
| |
| | — | ||||
Outstanding as of December 31, 2019 |
| | $ | | $ | |
| |||
Granted |
| |
| |
| |
| — | ||
Forfeited |
| ( |
| |
| |
| — | ||
Outstanding as of December 31, 2020 |
| | $ | | $ | |
| |||
Exercisable as of December 31, 2020 |
| | $ | | $ | |
|
During 2020, in connection with the issuance of the Oaktree Note, the Company issued warrants to purchase
Long-Term Incentive Program (“LTIP”)
On July 15, 2015, the stockholders approved the LTIP for the Company’s Chairman, President and Chief Executive Officer, Dr. Rosenwald, and Executive Vice Chairman, Strategic Development, Mr. Weiss. The LTIP consists of a program to grant equity interests in the Company and in the Company’s subsidiaries, and a performance-based bonus program that is designed to 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, 2020 and 2019, the Compensation Committee granted
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Capital Raise
2019 Common Stock At the Market Offering
On June 28, 2019, the Company entered into an At Market Issuance Sales Agreement (“2019 Common ATM”), with Cantor Fitzgerald & Co., Oppenheimer & Co., Inc., H.C. Wainwright & Co. Inc., Jones Trading Institutional Services LLC and B. Riley, as selling agents, governing potential sales of the Company’s common stock. For the years ended December 31, 2020 and 2019, the Company issued approximately
Common Stock At the Market Offering
On August 17, 2016, the Company entered into an Amended and Restated At Market Issuance Sales Agreement, or Sales Agreement, with MLV & Co. LLC, or MLV, and FBR Capital Markets & Co., or FBR (“ATM”). On August 18, 2016, the Company filed a Registration Statement on Form S-3, which became effective on December 1, 2016 and permits the Company to issue and sell shares of its common stock having an aggregate offering price of up to $
Pursuant to the terms of the ATM, for the year ended December 31, 2019, the Company issued approximately
2019
In November 2019, the Company completed an underwritten public offering of
On February 14, 2020, the Company announced the closing of an underwritten public offering, whereby it sold
On May 29, 2020, the Company closed on an underwritten public offering whereby it sold
On August 26, 2020, the Company closed on an underwritten public offering whereby it sold
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2018
On April 5, 2018, the Company entered into an At Market Sales Agreement (the “2018 Preferred ATM”), with B. Riley, National Securities Corporation, LifeSci Capital LLC, Maxim Group LLC and Noble Capital Markets, Inc. as selling agents, governing the issuance of the Company’s
The above-mentioned shares of Perpetual Preferred Stock were sold under the 2016 Shelf. The 2016 Shelf expired on
2019 Shelf
The 2019 offerings of both common stock and preferred stock were sold under the Company’s shelf registration statement on Form S-3 originally filed on July 6, 2018 and declared effective July 23, 2019 (the “2019 Shelf”). The shares of common stock were sold under the Company’s shelf registration statement on Form S-3 originally filed on July 6, 2018 and declared effective July 23, 2019 (the “2019 Shelf”) through May 27, 2020.
2020 Shelf
On May 18, 2020, the Company filed a new shelf registration statement on Form S-3, which was declared effective on May 26, 2020 (the "2020 Shelf"). In connection with the 2020 Shelf, the Company entered into an At Market Issuance Sales Agreement ("2020 Common ATM"), with Cantor Fitzgerald & Co., Oppenheimer & Co., Inc., H.C. Wainwright & Co. Inc., B. Riley and Dawson James Securities, Inc., as selling agents, governing potential sales of the Company's common stock. ATM sales commencing on June 1, 2020 were made under the 2020 Shelf as were Perpetual Preferred Offerings. Approximately $
Cyprium
On August 28, 2020, Cyprium closed on an underwritten public offering whereby it sold
Pursuant to the terms of the Cyprium PPS, shareholders on the record date are entitled to receive a monthly cash dividend of $
An optional exchange to Company 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 is either automatically exchanged for Company Preferred Stock or cash at the discretion of Fortress. The Cyprium PPS is fully and unconditionally guaranteed by Fortress.
Cyprium paid an initial dividend of $
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Checkpoint Therapeutics, Inc.
In November 2017, the Checkpoint filed a shelf registration statement on Form S-3 (No. 333-221493) (the "Checkpoint 2017 S-3"), which was declared effective in December 2017. Under the Checkpoint S-3, Checkpoint may sell up to a total of $
During the year ended December 31, 2020, Checkpoint sold a total of
During the year ended December 31, 2019, Checkpoint sold a total of
In September 2020, Checkpoint completed an underwritten public offering in which it sold
In November 2019, Checkpoint completed an underwritten public offering of
In November 2020, Checkpoint filed a shelf registration statement on Form S-3 (the “Checkpoint 2020 S-3”), which was declared effective in December 2020. Under the Checkpoint 2020 S-3, Checkpoint may sell up to a total of $
As of December 31, 2020, approximately $
Mustang Bio, Inc.
On July 13, 2018, Mustang filed a shelf registration statement No. 333-226175 on Form S-3 , as amended on July 20, 2018 (the "2018 Mustang S-3"), which was declared effective in August 2018. Under the 2018 Mustang S-3, Mustang may sell up to a total of $
During the year ended December 31, 2020, Mustang issued approximately
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During the year ended December 31, 2019, Mustang issued approximately
On June 11, 2020, Mustang entered into an underwriting agreement (the “Mustang Underwriting Agreement”) with Cantor Fitzgerald & Co., as representative of the underwriters named therein (each, an “Underwriter” and collectively with Cantor Fitzgerald & Co., the “Underwriters”). In connection with the Mustang Underwriting Agreement, Mustang issued
In April 2019, Mustang completed an underwritten public offering of
On October 23, 2020, Mustang filed a shelf registration statement No. 333-249657 on Form S-3 (the "2020 Mustang S-3"), which was declared effective on December 4, 2020. Under the 2020 Mustang S-3, Mustang may sell up to a total of $
On August 16, 2019, Mustang filed a shelf registration statement No. 333-233350 on Form S-3 (the "2019 Mustang S-3"), which was declared effective on September 30, 2019. Under the 2019 Mustang S-3, Mustang may sell up to a total of $
15. Commitments and Contingencies
Leases
On October 3, 2014, the Company entered into a
In October 2015, the Company entered into a
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Journey
In June 2017, Journey extended its lease for
Mustang
On October 27, 2017, Mustang entered into a lease agreement with WCS - 377 Plantation Street, Inc., a Massachusetts nonprofit corporation (“Landlord”). Pursuant to the terms of the lease agreement, Mustang agreed to lease
The terms of the lease also require that Mustang post an initial security deposit of $
The Facility began operations for the production of personalized CAR T and gene therapies in 2018.
The Company leases copiers under agreements classified as operating leases that expire on various dates through 2024.
Most of the Company’s lease liabilities result from the lease of its New York City, NY office, which expires in
During the years ended December 31, 2020 and 2019, the Company recorded $
| Year Ended December 31, | |||||
($ in thousands) | 2020 | 2019 | ||||
Lease Cost |
| |||||
Operating lease cost | $ | | $ | | ||
Shared lease costs |
| ( | ( | |||
Variable lease cost |
| | | |||
Total lease expense | $ | | $ | |
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The following tables summarize quantitative information about the Company’s operating leases, under the adoption of ASC Topic 842, Leases:
| Year Ended December 31, |
| |||||
($ in thousands) | 2020 | 2019 |
| ||||
Operating cash flows from operating leases | $ | ( | $ | ( | |||
Right-of-use assets exchanged for new operating lease liabilities | | — | |||||
Weighted-average remaining lease term – operating leases (years) |
|
| |||||
Weighted-average discount rate – operating leases |
| | % |
| | % |
| Future Lease | ||
($ in thousands) | Liability | ||
Year Ended December 31, 2021 | $ | | |
Year Ended December 31, 2022 |
| | |
Year Ended December 31, 2023 |
| | |
Year Ended December 31, 2024 |
| | |
Year Ended December 31, 2025 |
| | |
Other |
| | |
Total operating lease liabilities |
| | |
Less: present value discount |
| ( | |
Net operating lease liabilities, short-term and long-term | $ | |
The Company recognizes rent expense on a straight-line basis over the non-cancellable lease term. Rent expense for the years ended December 31, 2020 and 2019 was $
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. Pursuant to agreements with clinical trial sites, the Company provides indemnification to such sites in certain conditions.
Legal Proceedings
In the ordinary course of business, the Company and its subsidiaries may be subject to both insured and uninsured litigation. Suits and claims may be brought against the Company by customers, suppliers, partners and/or third parties (including tort claims for personal injury arising from clinical trials of the Company’s product candidates and property damage) alleging deficiencies in performance, breach of contract, etc., and seeking resulting alleged damages.
In November 2020, a purported securities class action complaint was filed in the U.S. District Court for the Eastern District of New York, putatively on behalf of all shareholders who purchased or otherwise acquired Fortress securities between December 11, 2019 and October 9, 2020 (the “Class Period”), and who were allegedly damaged in connection therewith. The case is captioned Cushman v. Fortress Biotech, Inc., et al., Case No. 1:20-cv-05767, and names as defendants the Company and two of our officers. The complaint alleges that, throughout the Class Period, the Company made false and/or misleading statements and/or failed to disclose various facts and circumstances with respect to a New Drug Application filed by Avenue Therapeutics, Inc., our partner company, regarding IV Tramadol, Avenue’s lead product candidate. The complaint alleges violations of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder, and seeks damages as well as attorneys’ fees, expert fees and other costs. The action is in the early stages of litigation, and the Company intends to vigorously contest the claims.
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16. Employee Benefit Plan
On January 1, 2008, the Company adopted a defined contribution 401(k) plan which allows employees to contribute up to a percentage of their compensation, subject to IRS limitations and provides for a discretionary Company match up to a maximum of
17. Related Party Transactions
The Company’s Chairman, President and Chief Executive Officer, individually and through certain trusts over which he has voting and dispositive control, beneficially owned approximately
Shared Services Agreement with TGTX
In July 2015, TGTX and the Company entered into an arrangement to share the cost of certain research and development employees. The Company’s Executive Vice Chairman, Strategic Development, is Executive Chairman and Interim Chief Executive Officer of TGTX. Under the terms of the Agreement, TGTX will reimburse the Company for the salary and benefit costs associated with these employees based upon actual hours worked on TGTX related projects. In connection with the shared services agreement, the Company invoiced TGTX $
Desk Share Agreements with TGTX and OPPM
In September 2014, the Company entered into Desk Share Agreements with TGTX and Opus Point Partners Management, LLC (“OPPM”) to occupy
In connection with the Company’s Desk Space Agreements for the New York, NY office space, for the years ended December 31, 2020 and 2019, the Company had paid $
As of July 1, 2018, TGTX employees began to occupy desks in the Waltham, MA office under the Desk Share Agreement. TGTX began to pay their share of the rent based on actual percentage of the office space occupied on a month by month basis. For the years ended December 31, 2020 and 2019, the Company had paid approximately $
As of December 31, 2020 and 2019, the Company had paid a total of $
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Checkpoint Collaborative Agreements with TGTX
Checkpoint has entered into various agreements with TGTX to develop and commercialize certain assets in connection with its licenses, including a collaboration agreement for some of the Dana Farber licensed antibodies, and a sublicense agreement for the Jubilant family of patents. Checkpoint believes that by partnering with TGTX to develop these compounds in therapeutic areas outside of its business focus, it may substantially offset its preclinical costs and milestone costs related to the development and marketing of these compounds in solid tumor indications.
2019 Notes (formerly the Opus Credit Facility)
On September 14, 2016, the Company and Opus Point Health Innovations Fund (“OPHIF”) entered into a Credit Facility Agreement (the “Opus Credit Facility”). Fortress’s Chairman, President and Chief Executive Officer (Lindsay A. Rosenwald) and Fortress’s Executive Vice President, Strategic Development (Michael Weiss), are Co-Portfolio Managers and Partners of OPPM, an affiliate of OPHIF. As such, all of the disinterested directors of Fortress’s board of directors approved the terms of the Opus Credit Facility and related agreements.
On March 12, 2018, the Company and OPHIF amended and restated the Opus Credit Facility (the “A&R Opus Credit Facility”). The A&R Opus Credit Facility extended the maturity date of the notes issued under the Opus Credit Facility from
Effective December 31, 2019, OPHIF dissolved and distributed it assets among its limited partners. Following the distribution, the $
During the year ended December 31, 2020, the Company used certain proceeds from the Oaktree Note to pay off the $
2018 Venture Notes
For the year ended December 31, 2018, the Company raised approximately $
2017 Subordinated Note Financing
On March 17, 2017, the Company and NSC entered into placement agency agreements with NAM Biotech Fund and NAM Special Situation Fund in connection with the sale of subordinated promissory notes (see Note 10). Pursuant to the terms of the agreements, NSC received a placement agent fee in cash of
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For the year ended December 31, 2017, NSC earned a placement agent fee of $
Avenue Credit Facility Agreement
On June 12, 2020, Avenue, the Company and InvaGen entered into a Facility Agreement (“Avenue Facility Agreement”), under which, beginning on October 1, 2020, Avenue may borrow up to $
Founders Agreement and Management Services Agreement
The Company has entered into Founders Agreements with each of the Fortress partner companies listed in the table below. Pursuant to each Founders Agreement, in exchange for the time and capital expended in the formation of each partner company and the identification of specific assets the acquisition of which result in the formation of a viable emerging growth life science company, the Company will loan each such partner company an amount representing the up-front fee required to acquire assets. Each Founders Agreement has a term of
The Class A Preferred Stock (Class A Common Stock with respect to Checkpoint) is identical to common stock other than as to voting rights, conversion rights and the PIK Dividend right (as described below). Each share of Class A Preferred Stock (Class A Common Stock with respect to Checkpoint) is entitled to vote the number of votes that is equal to one and one-tenth (1.1) times a fraction, the numerator of which is the sum of (A) the shares of outstanding common stock and (B) the whole shares of common stock into which the shares of outstanding Class A Preferred Stock (Class A Common Stock with respect to Checkpoint) are convertible and the denominator of which is the number of shares of outstanding Class A Preferred Stock (Class A Common Stock with respect to Checkpoint). Thus, the Class A Preferred Stock (Class A Common Stock with respect to Checkpoint) will at all times constitute a voting majority. Each share of Class A Preferred Stock (Class A Common Stock with respect to Checkpoint) is convertible, at the holder’s option, into one fully paid and nonassessable share of common stock of such partner company, subject to certain adjustments.
The holders of Class A Preferred Stock (and the Class A Common Stock with respect to Checkpoint), as a class, are entitled receive on each effective date or “Trigger Date” (defined as the date that the Company first acquired, whether by license or otherwise, ownership rights to a product) of each agreement (each a “PIK Dividend Payment Date”) until the date all outstanding Class A Preferred Stock (Class A Common Stock with respect to Checkpoint) is converted into common stock or redeemed (and the purchase price is paid in full), pro rata per share dividends paid in additional fully paid and nonassessable shares of common stock (“PIK Dividends”) such that the aggregate number of shares of common stock issued pursuant to such PIK Dividend is equal to two and one-half percent (
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As additional consideration under the Founders Agreement, each partner company with which the Company has entered into a Founders Agreement will also: (i) pay an equity fee in shares of the common stock of such partner company, payable within
The following table summarizes, by subsidiary, the effective date of the Founders Agreements and PIK dividend or equity fee payable to the Company in accordance with the terms of the Founders Agreements, Exchange Agreements and the partner companies’ certificates of incorporation.
PIK Dividend as | ||||||
a % of fully | ||||||
diluted | ||||||
outstanding | Class of Stock | |||||
Fortress Partner Company |
| Effective Date 1 |
| capitalization |
| Issued |
Helocyte |
| | % | Common Stock | ||
Avenue |
| %2 | Common Stock | |||
Mustang |
| | % | Common Stock | ||
Checkpoint |
| %3 | Common Stock | |||
Cellvation |
| | % | Common Stock | ||
Caelum |
| %4 | Common Stock | |||
Baergic | | % | Common Stock | |||
Cyprium |
| | % | Common Stock | ||
Aevitas |
| | % | Common Stock | ||
Oncogenuity | | % | 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: | Pursuant to the terms of the agreement between Avenue and InvaGen Pharmaceuticals, Inc. during the term of the Avenue SPMA PIK dividends will not be paid or accrued. |
Note 3: | Instead of a PIK dividend, Checkpoint pays the Company an annual equity fee in shares of Checkpoint’s common stock equal to |
Note 4: | Effective January 31, 2019 the Caelum Founders Agreement and MSA with Fortress were terminated in conjunction with the execution of the DOSPA between Caelum and Alexion (See Note 4). |
Note 5: | Represents the Trigger Date, the date that the Fortress partner company first acquires, whether by license or otherwise, ownership rights in a product. |
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Equity Fees
The following table summarizes, by subsidiary, the PIK dividend or equity fee recorded by the Company in accordance with the terms of the Founders Agreements, Exchange Agreements and the partner companies’ certificates of incorporation for the years ended December 31, 2020 and 2019 ($ in thousands):
PIK Dividend | Year Ended | Year Ended | ||||||
Partner company |
| Date |
| December 31, 20201 |
| December 31, 2019 | ||
Aevitas | $ | | $ | | ||||
Caelum2 |
|
| |
| | |||
Cellvation |
|
| |
| | |||
Checkpoint |
|
| |
| | |||
Cyprium |
|
| |
| | |||
Helocyte |
|
| |
| | |||
Mustang |
|
| |
| | |||
Tamid |
|
| |
| | |||
Fortress |
| ( |
| ( | ||||
Total | $ | | $ | |
Note 1: Includes 2021 PIK dividend accrued for the year ended December 31, 2020, as Type 1 subsequent event.
Note 2: Pursuant to the terms of the Amended and Restated Mutual Conditional Termination Agreement between Fortress and Caelum, the Founders Agreement dated January 1, 2017 was terminated upon signing of the DOSPA with Alexion on January 30, 2019.
Management Services Agreements
The Company has entered into Management Services Agreements (the “MSAs”) with certain of its partner companies. Pursuant to each MSA, the Company’s management and personnel provide advisory, consulting and strategic services to each partner company that has entered into an MSA with Fortress for a period of
(5) years. Such services may include, without limitation, (i) advice and assistance concerning any and all aspects of each such partner company’s operations, clinical trials, financial planning and strategic transactions and financings and (ii) conducting relations on behalf of each such partner company with accountants, attorneys, financial advisors and other professionals (collectively, the “Services”). Each such partner company is obligated to utilize clinical research services, medical education, communication and marketing services and investor relations/public relation services of companies or individuals designated by Fortress, provided those services are offered at market prices. However, such partner companies are not obligated to take or act upon any advice rendered from Fortress, and the Company shall not be liable to any such partner company for its actions or inactions based upon the Company’s advice. The Company and its affiliates, including all members of Fortress’ Board of Directors, have been contractually exempted from fiduciary duties to each such partner company relating to corporate opportunities.F-71
The following table summarizes, by partner company, the effective date of the MSA and the annual consulting fee payable by the subsidiary to the Company in quarterly installments ($ in thousands):
Year Ended December 31, | ||||||||
Fortress partner company |
| Effective Date |
| 2020 |
| 2019 | ||
Helocyte | $ | | $ | | ||||
Avenue 1 |
| |
| | ||||
Mustang |
| |
| | ||||
Checkpoint |
| |
| | ||||
Cellvation |
| |
| | ||||
Baergic |
| |
| | ||||
Cyprium |
| |
| | ||||
Aevitas |
| |
| | ||||
Tamid2 |
| |
| | ||||
Oncogenuity3 | | | ||||||
Fortress - MSA Income |
| ( |
| ( | ||||
Consolidated (Income)/Expense | $ | | $ | |
Note 1: Pursuant to the terms of the agreement between Avenue and InvaGen Pharmaceuticals, Inc. during the term of the Avenue SPMA fees under the MSA will not be due or accrued.
Note 2: In December 2019, Tamid discontinued development and terminated its’ licenses and clinical trial agreements with UNC.
Note 3: Oncogenuity license was purchased in the year ended December 31, 2020.
Fees and Stock Grants Received by Fortress
Fees recorded in connection with the Company’s agreements with its subsidiaries 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.
18. Income Taxes
Deferred income taxes reflect the net tax effects of (a) temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, and (b) operating losses and tax credit carryforwards.
The components of the income tax provision (benefit) are as follows:
For the Year Ended December 31, | ||||||
($ in thousands) |
| 2020 |
| 2019 | ||
Current |
|
| ||||
Federal | $ | | $ | | ||
State |
| |
| | ||
Deferred |
|
|
|
| ||
Federal |
| |
| | ||
State |
| |
| | ||
Total | $ | | $ | |
For the years ended December 31, 2020 and 2019, income tax expense was $
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The Company has incurred net operating losses since inception. The Company has not reflected any benefit of such net operating loss carryforwards (“NOL”) in the accompanying consolidated financial statements and has established a valuation allowance of $
The significant components of the Company’s deferred taxes consist of the following:
As of December 31, | ||||||
($ in thousands) | 2020 | 2019 | ||||
Deferred tax assets: |
|
|
|
| ||
Net operating loss carryforwards | $ | | $ | | ||
Amortization of license fees |
| |
| | ||
Amortization of in-process R&D |
| |
| | ||
Stock compensation |
| |
| | ||
Lease liability |
| |
| | ||
Accruals and reserves |
| |
| | ||
Tax credits |
| |
| | ||
Startup costs |
| |
| | ||
Unrealized gain/loss on investments |
| |
| | ||
State taxes |
| |
| | ||
Reserve on Sales Return, Discount and Bad Debt | | | ||||
Total deferred tax assets |
| |
| | ||
Less: valuation allowance |
| ( |
| ( | ||
Net deferred tax assets | $ | | $ | | ||
Deferred tax liabilities: |
|
|
|
| ||
Right of use asset | $ | ( | $ | ( | ||
Fair Value adjustment on investment in Caelum |
| ( | ( | |||
Basis in subsidiary |
| ( |
| ( | ||
Total deferred tax assets, net | $ | | $ | |
A reconciliation of the statutory tax rates and the effective tax rates is as follows:
For the Year Ended December 31, |
| ||||
| 2020 |
| 2019 |
| |
Percentage of pre-tax income: |
|
| |||
U.S. federal statutory income tax rate |
| | % | | % |
State taxes, net of federal benefit |
| | % | | % |
Credits |
| | % | | % |
Non-deductible items |
| ( | % | | % |
Provision to return |
| | % | | % |
Stock based compensation shortfall |
| ( | % | ( | % |
Change in state rate |
| | % | | % |
Deconsolidation of Caelum |
| | % | ( | % |
Change in valuation allowance |
| ( | % | ( | % |
Change in subsidiary basis |
| | % | ( | % |
Other |
| ( | % | | % |
Effective income tax rate |
| | % | | % |
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The Company files a consolidated income tax return with subsidiaries for which the Company has an
ASC 740 requires a valuation allowance to reduce the deferred tax assets reported if, based on the weight of all positive and negative evidence, it is more likely than not that some portion, or all, of the deferred tax assets will not be realized. Realization of the deferred tax assets is substantially dependent on the Company’s ability to generate sufficient taxable income within certain future periods. Management has considered the Company’s history of cumulative tax and book losses incurred since inception, and the other positive and negative evidence, and has concluded that it is more likely than not that the Company will not realize the benefits of the net deferred tax assets as of December 31, 2020 and 2019. Accordingly, a full valuation allowance has been established against the net deferred tax assets as of December 31, 2020 and 2019. The valuation allowance increased by a net $
The Company has incurred net operating losses (“NOLs”) since inception. At December 31, 2020, the Company had federal NOLs of $
As of December 31, 2020, th Company had
In January 2019, in connection with the Alexion DOSPA, the Company ceased to consolidate Caelum (see Note 4). As a result of the deconsolidation of Caelum, the Company has eliminated Caelum’s deferred tax assets and the valuation allowance for a net tax expense charge or benefit of
Coronavirus Aid, Relief and Economic Security Act ("CARES Act")
In response to the COVID-19 pandemic, the Coronavirus Aid, Relief and Economic Security Act ("CARES Act") was signed into law on March 27, 2020. The CARES Act, among other things, includes tax provisions relating to refundable payroll tax credits, deferment of employer's social security payments, net operating loss utilization and carryback periods and modifications to the net interest deduction limitations. The CARES Act did not have a material impact on the Company’s income tax provision for 2020. The Company will continue to evaluate the impact of the CARES Act on its financial position, results of operations and cash flows.
On December 27, 2020, the President of the United States signed the Consolidated Appropriations Act, 2021 (“Consolidated Appropriations Act”) into law. The Consolidated Appropriations Act is intended to enhance and expand certain provisions of the CARES Act, allows for the deductions of expenses related to the Paycheck Protection Program funds received by companies, and provides an update to meals and entertainment expensing for 2021. The Consolidated Appropriations Act did not have a material impact to the Company’s income tax provision for 2020.
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19. Segment Information
The Company operates in
Pharmaceutical |
| ||||||||
and | |||||||||
Dermatology | Biotechnology | ||||||||
($ in thousands) | Products | Product | |||||||
Year Ended December 31, 2020 |
| Sales |
| Development |
| Consolidated | |||
Net revenue | $ | | $ | | $ | | |||
Direct cost of goods |
| ( |
| |
| ( | |||
Sales and marketing costs |
| ( |
| |
| ( | |||
Research and development |
| |
| ( |
| ( | |||
General and administrative | ( | ( | ( | ||||||
Other expense |
| ( |
| ( |
| ( | |||
Income tax expense | ( | ( | ( | ||||||
Segment income (loss) | $ | | $ | ( | $ | ( | |||
Segment assets | |||||||||
Intangible assets, net | | | | ||||||
Tangible assets | | | | ||||||
Total segment assets | $ | | $ | | $ | |
Pharmaceutical | |||||||||
and | |||||||||
Dermatology | Biotechnology | ||||||||
($ in thousands) | Products | Product | |||||||
Year Ended December 31, 2019 |
| Sales |
| Development |
| Consolidated | |||
Net revenue | $ | | $ | | $ | | |||
Direct cost of goods |
| ( |
| |
| ( | |||
Sales and marketing costs |
| ( |
| |
| ( | |||
Research and development |
| |
| ( |
| ( | |||
General and administrative |
| ( |
| ( |
| ( | |||
Other income |
| |
| |
| | |||
Segment income (loss) | $ | | $ | ( | $ | ( | |||
Segment assets | |||||||||
Intangible assets, net |
| | | | |||||
Tangible assets |
| | | | |||||
Total segment assets | $ | | $ | | $ | |
20. Revenues from Contracts and Significant Customers
Disaggregation of Total Revenues
The Company has
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The table below summarizes the Company’s revenue for the years ended December 31, 2020 and 2019:
Year Ended December 31, | |||||||
($ in thousands) |
| 2020 |
| 2019 |
| ||
Revenue | |||||||
Product revenue, net | $ | | $ | | |||
Revenue – related party |
| |
| | |||
Net revenue | $ | | $ | |
Significant Customers
For the year ended December 31, 2020, none of the Company’s Dermatology Products customers accounted for more than 10.0% of its total gross product revenue.
For the year ended December 31, 2019, two of the Company’s Dermatology Products customers each accounted for more than 10.0% of its total gross product revenue, accounting for approximately
At December 31, 2020, one of the Company’s Dermatology Products customers accounted for
At December 31, 2019, two of the Company’s Dermatology Products customers accounted for more than 10% of its total accounts receivable balance at
Included in Product revenue, net, for the years ended December 31, 2020 and 2019 was $
Revenue – related party represents collaboration revenue from TGTX in connection with Checkpoint.
21. Subsequent Events
Cyprium
On February 24, 2021, Cyprium announced the execution of an asset purchase agreement with Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based specialty pharmaceutical company owned by the Zydus Group. The asset purchase agreement commits Sentynl to an upfront cash payment to Cyprium of $
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Avenue
On February 12, 2021, Avenue resubmitted its NDA to the FDA for IV Tramadol. The NDA for IV Tramadol was resubmitted following the receipt of official minutes from a Type A meeting with the FDA, which was conducted following a CRL issued by the FDA in October 2020. The resubmission included revised language relating to the proposed product label and a report relating to terminal sterilization validation. On February 26, 2021, Avenue received an acknowledgement letter from the FDA that Avenue’s resubmission of its NDA is a complete, class 1 response to the CRL, and a Prescription Drug User Fee Act goal date has been set for April 12, 2021.
Journey
In March 2021, our partner company Journey is conducting an offering to accredited investors of
In addition, if the Journey preferred stock has not been converted into Journey common stock upon a sale of Journey or a financing of Journey in an amount of at least $
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
| Fortress Biotech, Inc. | |
|
|
| |
April 9, 2021 | By: | /s/ Lindsay A. Rosenwald, M.D. | |
|
| Lindsay A. Rosenwald, M.D. | |
|
| Chairman, President and Chief Executive Officer |
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