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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K/A

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Fiscal Year Ended December 31, 2020

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. 001-35366

FORTRESS BIOTECH, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware

    

20-5157386

(State or Other Jurisdiction of

Incorporation or Organization)

 

(I.R.S. Employer

Identification No.)

 

 

 

2 Gansevoort Street, 9th Floor

 

 

New York, New York 10014

 

10014

(Address of Principal Executive Offices)

 

(Zip Code)

Registrant’s telephone number, including area code: (781) 652-4500

Securities registered pursuant to Section 12(b) of the Act:

Title of Class

   

Trading Symbol(s)

   

Exchange Name

Common Stock

 

FBIO

Nasdaq Capital Market

9.375% Series A Cumulative Redeemable Perpetual Preferred Stock

FBIOP

Nasdaq Capital Market

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      No     

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      No     

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. Yes      No     

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). Yes      No     

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     

Non-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      No     

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: $173,878,853 based upon the closing sale price of our common stock of $2.68 on that date. Common stock held by each officer and director and by each person known to own in excess of 5% of outstanding shares of our common stock has been excluded in that such persons may be deemed to be affiliates. The determination of affiliate status in not necessarily a conclusive determination for other purposes.

Class of Stock

    

Outstanding Shares as of March 18, 2021

Common Stock, $0.001 par value

 

94,907,448

9.375% Series A Cumulative Redeemable Perpetual Preferred Stock, $0.001 par value

 

3,427,138

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.

(a)Financial Statements.

The following financial statements are filed as part of this report:

Reports of Independent Registered Public Accounting Firm

F-2

Consolidated Balance Sheets

F-4

Consolidated Statements of Operations

F-5

Consolidated Statements of Changes in Stockholders’ Equity

F-6

Consolidated Statements of Cash Flows

F-8

Notes to the Consolidated Financial Statements

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:  

Evaluating management’s accounting policies and practices including the appropriateness of

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

 

  

 

  

Current assets

 

  

 

  

Cash and cash equivalents

$

233,351

$

136,858

Accounts receivable, net

 

19,349

 

13,539

Inventory

 

1,404

 

857

Other receivables - related party

 

744

 

865

Prepaid expenses and other current assets

 

6,723

 

4,133

Total current assets

 

261,571

 

156,252

Property and equipment, net

 

11,923

 

12,433

Operating lease right-of-use asset, net

 

20,487

 

21,480

Restricted cash

 

1,645

 

16,574

Long-term investment, at fair value

 

17,566

 

11,148

Intangible asset, net

 

14,629

 

7,377

Other assets

 

1,013

 

1,158

Total assets

$

328,834

$

226,422

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

Current liabilities

 

 

  

Accounts payable and accrued expenses

$

40,674

$

35,451

Interest payable

 

 

1,042

Interest payable - related party

 

 

92

Income taxes payable

136

Notes payable, short-term

 

 

7,220

Operating lease liabilities, short-term

 

1,849

 

1,784

Derivative warrant liability

 

 

27

Partner company note payable, short-term

5,300

Total current liabilities

 

47,959

 

45,616

Notes payable, long-term (net of debt discount of $8,323 and $5,086 at December 31, 2020 and December 31, 2019, respectively)

 

51,677

 

77,436

Operating lease liabilities, long-term

 

22,891

 

23,712

Partner company note payable, long-term

 

7,359

 

4,990

Other long-term liabilities

 

1,949

 

2,136

Total liabilities

131,835

153,890

 

 

Commitments and contingencies

 

  

 

  

Stockholders’ equity

 

  

 

  

Cumulative redeemable perpetual preferred stock, $.001 par value, 15,000,000 authorized, 5,000,000 designated Series A shares, 3,427,138 and 1,341,167 shares issued and outstanding as of December 31, 2020 and December 31, 2019, respectively; liquidation value of $25.00 per share

 

3

 

1

Common stock, $.001 par value, 150,000,000 and 100,000,000 shares authorized, 94,877,492 and 74,027,425 shares issued and outstanding as of December 31, 2020 and December 31, 2019, respectively

 

95

 

74

Common stock issuable, 0 and 251,337 shares as of December 31, 2020 and December 31, 2019, respectively

 

 

500

Additional paid-in-capital

 

583,000

 

461,874

Accumulated deficit

 

(482,760)

 

(436,234)

Total stockholders' equity attributed to the Company

 

100,338

 

26,215

Non-controlling interests

 

96,661

 

46,317

Total stockholders' equity

 

196,999

 

72,532

Total liabilities and stockholders' equity

$

328,834

$

226,422

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

 

  

 

  

Product revenue, net

$

44,531

$

34,921

Revenue - related party

 

1,068

 

1,708

Net revenue

 

45,599

 

36,629

Operating expenses

 

 

Cost of goods sold - product revenue

 

14,594

 

10,532

Research and development

 

61,275

 

75,236

Research and development - licenses acquired

 

2,834

 

6,090

Selling, general and administrative

 

61,166

 

55,590

Total operating expenses

 

139,869

 

147,448

Loss from operations

 

(94,270)

 

(110,819)

Other income (expense)

 

 

Interest income

 

1,518

 

2,559

Interest expense and financing fee

 

(15,326)

 

(11,849)

Change in fair value of derivative liability

 

(1,189)

 

(27)

Change in fair value of investments

 

6,418

 

Gain on deconsolidation of Caelum

 

 

18,476

Total other income (expense)

 

(8,579)

 

9,159

Loss before income tax expense

(102,849)

(101,660)

Income tax expense

136

Net loss

 

(102,985)

 

(101,660)

Less: net loss attributable to non-controlling interests

 

56,459

 

61,700

Net loss attributable to common stockholders

$

(46,526)

$

(39,960)

Net loss per common share - basic and diluted

$

(1.43)

$

(1.86)

Net loss per common share attributable to non - controlling interests - basic and diluted

$

(0.78)

$

(1.13)

Net loss per common share attributable to common stockholders - basic and diluted

$

(0.65)

$

(0.73)

Weighted average common shares outstanding - basic and diluted

 

72,005,181

 

54,711,838

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'

    

Shares

    

Shares

    

Amount

    

Issuable

    

Stock

    

Capital

    

Deficit

    

Interests

    

Equity

Balance at December 31, 2018

 

1,000,000

$

1

 

57,845,447

$

58

$

659

$

$

397,408

$

(396,274)

$

17,891

$

19,743

Stock-based compensation expense

 

 

 

 

 

 

 

13,188

 

 

 

13,188

Settlement of restricted stock units into common stock

 

 

 

1,905,367

 

2

 

 

 

(2)

 

 

 

Issuance of common stock under ESPP

 

 

 

98,007

 

 

 

 

123

 

 

 

123

Issuance of common stock for at-the-market offering, net

 

 

 

11,798,468

 

12

 

 

 

20,235

 

 

 

20,247

Issuance of Series A preferred stock for at-the-market offering, net

 

39,292

 

 

 

 

 

 

788

 

 

 

788

Issuance of Series A preferred stock for cash, net

 

301,875

 

 

 

 

 

 

5,307

 

 

 

5,307

Preferred A dividends declared and paid

 

 

 

 

 

 

 

(2,559)

 

 

 

(2,559)

Partner company’s offering, net