UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q


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

For the quarterly period ended June 30, 2023


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

For the transition period from to

Commission File Number 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.)

1111 Kane Concourse Suite 301

Bay Harbor Islands, FL 33154

(Address including zip code of principal executive offices)

(781) 652-4500

(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
Common Stock	FBIO	Nasdaq Capital Market
9.375% Series A Cumulative Redeemable Perpetual Preferred Stock	FBIOP	Nasdaq Capital Market

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, smaller reporting company, or an emerging growth company. See the definitions 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 registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒



Class of Stock		Outstanding Shares as of August 9, 2023
Common Stock, $0.001 par value		132,787,335
9.375% Series A Cumulative Redeemable Perpetual Preferred Stock, $0.001 par value		3,427,138

Table of Contents

FORTRESS BIOTECH, INC. AND SUBSIDIARIES

Quarterly Report on Form 10-Q

TABLE OF CONTENTS


PART I.	FINANCIAL INFORMATION	1
Item 1.	Unaudited Condensed Consolidated Financial Statements	1
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	37
Item 3.	Quantitative and Qualitative Disclosures About Market Risks	52
Item 4.	Controls and Procedures	53

PART II.	OTHER INFORMATION	53
Item 1.	Legal Proceedings	53
Item 1A.	Risk Factors	53
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	87
Item 3.	Defaults Upon Senior Securities	87
Item 4.	Mine Safety Disclosures	87
Item 5.	Other Information	87
Item 6.	Exhibits	88

SIGNATURES		90

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SUMMARY RISK FACTORS

Our business is subject to risks of which you should be aware before making an investment decision. The risks described below are a summary of the principal risks associated with an investment in us and are not the only risks we face. You should carefully consider these risk factors, the risk factors described in Item 1A, and the other reports and documents that we have filed with the Securities and Exchange Commission (“SEC”). As used below and throughout this filing (including in the risk factors described in Item 1A), the words “we”, “us” and “our” may refer to Fortress Biotech, Inc. individually, to one or more of its subsidiaries and/or partner companies, or to all such entities as a group, as dictated by context.

Risks Inherent in Drug Development

●

Many of our product candidates are in early development stages and are subject to time and cost intensive regulation and clinical testing, which may result in the identification of safety or efficacy concerns. As a result, our product candidates may never be successfully developed or commercialized.

●

Our competitors may develop treatments for our products’ target indications, which could limit our product candidates’ commercial opportunity and profitability.

Risks Pertaining to the Need for and Impact of Existing and Additional Financing Activities

●

We have a history of operating losses and expect such losses to continue in the future.

●

We have funded our operations in part through the assumption of debt, and the applicable lending agreements may restrict our operations. Further, the occurrence of any default event under an applicable loan document could adversely affect our business.

●

Our research and development (“R&D”) programs will require additional capital, which we may be unable to raise as needed and which may impede our R&D programs, commercialization efforts, or planned acquisitions.

●

If we raise additional capital by issuing equity or equity-linked securities, our existing stockholders will be diluted.

Risks Pertaining to Our Existing Revenue Stream from Journey Medical Corporation (“Journey”)

●

Our operating income derives primarily from the sale of our partner company Journey’s dermatology products, particularly Qbrexza, Accutane, Amzeeq, Zilxi, Targadox, Ximino, and Exelderm. Any issues relating to the manufacture, sale, utilization, or reimbursement of Journey’s products (including products liability claims) could significantly impact our operating results.

●

A significant portion of Journey’s sales derive from products that are without patent protection and/or are or may become subject to third party generic competition, the introduction of new competitor products, or an increase in market share of existing competitor products, any of which could have a significant adverse effect on our operating income. Four of Journey’s marketed products, Qbrexza, Amzeeq, Zilxi and Ximino, as well as DFD-29, a modified release oral minocycline for the treatment of rosacea licensed from Dr. Reddy’s Laboratories, currently have patent protection. Three of Journey’s marketed products, Accutane, Targadox, and Exelderm, do not have patent protection or otherwise are not eligible for patent protection. With respect to Journey products that are covered by valid claims of issued patents, such patents may be subject to invalidation, which would harm our operating income.

●

Continued sales and coverage, including formulary inclusion without the need for a prior authorization or step edit therapy, of Journey’s products for commercial sale will depend in part on the availability of reimbursement from third-party payors. Third-party payors are increasingly examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and efficacy, and, accordingly, significant uncertainty exists as to the reimbursement status of current and newly approved therapeutics.

Risks Pertaining to our Business Strategy, Structure and Organization

●

We have entered, and will likely in the future enter, into certain collaborations or divestitures which may cause a reduction in our business’ size and scope, market share and opportunities in certain markets, or our ability to compete in certain markets and therapeutic categories.

●

We and our subsidiaries and partner companies have also entered into, and intend in the future to enter into, arrangements under which we and/or they have agreed to contingent dispositions of such companies and/or their assets. The failure to consummate any such transaction may impair the value of such companies and/or assets, and we may not be able to identify or execute alternative arrangements on favorable terms, if at all. The consummation of any such arrangements with respect to certain product candidates may also result in our eligibility to receive a lower portion of sales (if any) of resulting approved products than if we had developed and commercialized such products ourselves.

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●

Our growth and success depend on our acquiring or in-licensing products or product candidates and integrating such products into our businesses.

●

We may act as guarantor and/or indemnitor of certain obligations of our subsidiaries and partner companies, which could require us to pay substantial amounts based on the actions or omissions of said entities.

Risks Pertaining to Reliance on Third Parties

●

We rely heavily on third parties for several aspects of our operations, including manufacturing and developing product candidates, conducting clinical trials, and producing commercial product supply. Such reliance on third-parties reduces our ability to control every aspect of the drug development process and may hinder our ability to develop and commercialize our products in a cost-effective and timely manner.

Risks Pertaining to Intellectual Property and Potential Disputes with Licensors Thereof

●

If we are unable to obtain and maintain patent protection for our technologies and products, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technologies and products similar or identical to ours, and our ability to successfully commercialize our technologies and products may be impaired.

●

We or our licensors may be subject to costly and time-consuming litigation for infringement of third-party intellectual property rights or to enforce our or our licensors’ patents.

●

Any dispute with our licensors may affect our ability to develop or commercialize our product candidates.

Risks Pertaining to Generic Competition and Paragraph IV Litigation

●

Generic drug companies may submit applications seeking approval to market generic versions of our products.

●

In connection with these applications, generic drug companies may seek to challenge the validity and enforceability of our patents through litigation and/or with the United States Patent and Trademark Office (“PTO”), such as the Paragraph IV certification made by Perrigo pertaining to the patents covering Qbrexza, and subsequently, Amzeeq, and Zilxi, three products being commercialized by our partner company Journey. Such challenges may subject us to costly and time-consuming litigation and/or PTO proceedings.

●

As a result of the loss of any patent protection from such litigation or PTO proceedings, or the “at-risk” launch by a generic competitor of our products, our products could be sold at significantly lower prices, and we could lose a significant portion of product sales in a short period of time, which could adversely affect our business, financial condition, operating results and prospects.

Risks Pertaining to the Commercialization of Product Candidates

●

If our products are not broadly accepted by the healthcare community, the revenues from any such products are likely to be limited.

●

We may not obtain the desired product labels or intended uses for product promotion, or favorable scheduling classifications desirable to successfully promote our products.

●

Even if a product candidate is approved, it may be subject to various post-marketing requirements, including studies or clinical trials, the results of which could cause such products to later be withdrawn from the market.

●

Any successful products liability claim related to any of our current or future product candidates may cause us to incur substantial liability and limit the commercialization of such products.

Risks Pertaining to Legislation and Regulation Affecting the Biopharmaceutical and Other Industries

●

We operate in a heavily regulated industry, and we cannot predict the impact that any future legislation or administrative or executive action may have on our operations.

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General and Other Risks

●

On October 31, 2022, we were notified by the Listing Qualification Staff (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) that the bid price of the Company’s common stock, par value $0.001 per share (the “Common Stock”), had closed below $1.00 per share for 30 consecutive business days and, as a result, the Company no longer satisfied Nasdaq Listing Rule 5550(a)(2), which sets forth the minimum bid price requirement for continued listing on The Nasdaq Capital Market. Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company was afforded an initial 180-calendar day grace period, through May 1, 2023, to regain compliance with the Rule 5550(a)(2).

●

On May 2, 2023, in accordance with Nasdaq Listing Rule 5810(c)(3)(A)(ii), the Staff granted the Company a second 180-calendar day grace period to regain compliance with the Rule 5550(a)(2). The Company intends to closely monitor the closing bid price for its Common Stock and consider all available options to remedy the bid price deficiency. In the event the Company is not able to demonstrate compliance with Rule 5550(a)(2) by October 30, 2023, the Staff will provide written notification that the Company’s Common Stock is subject to delisting, which the Company may appeal. The Company’s appeal request would stay any further action by the Staff at least pending a hearing before the Nasdaq Hearings Panel (the “Panel”) and the expiration of any extension that may be granted by the Panel to the Company following the hearing.

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PART I. FINANCIAL INFORMATION

Item 1. Unaudited Condensed Consolidated Financial Statements

FORTRESS BIOTECH, INC. AND SUBSIDIARIES

Unaudited Condensed Consolidated Balance Sheets

($ in thousands except for share and per share amounts)


	June 30,		December 31,
	2023		2022

ASSETS
Current assets
Cash and cash equivalents	$	78,022	$	178,266
Accounts receivable, net		16,737		28,208
Inventory		12,166		14,159
Other receivables - related party		273		138
Prepaid expenses and other current assets		7,315		9,661
Restricted cash		8,750		—
Assets held for sale		4,348		—
Total current assets		127,611		230,432

Property, plant and equipment, net		7,230		13,020
Operating lease right-of-use asset, net		17,951		19,991
Restricted cash		2,438		2,688
Intangible asset, net		21,916		27,197
Other assets		3,573		973
Total assets	$	180,719	$	294,301

LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities
Accounts payable and accrued expenses	$	99,162	$	97,446
Common stock warrant liabilities		9,971		13,869
Operating lease liabilities, short-term		2,329		2,447
Partner company term loan, short-term, net		9,942		—
Partner company convertible preferred shares, short-term, net		3,491		2,052
Partner company line of credit		—		2,948
Partner company installment payments - licenses, short-term, net		2,333		7,235
Other short-term liabilities		1,355		1,718
Total current liabilities		128,583		127,715

Notes payable, long-term, net		45,333		91,730
Operating lease liabilities, long-term		19,502		21,572
Partner company installment payments - licenses, long-term, net		1,490		1,412
Other long-term liabilities		1,754		1,847
Total liabilities		196,662		244,276

Commitments and contingencies (Note 14)

Stockholders’ equity (deficit)
Cumulative redeemable perpetual preferred stock, $0.001 par value, 15,000,000 authorized, 5,000,000 designated Series A shares, 3,427,138 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively, liquidation value of $25.00 per share		3		3
Common stock, $0.001 par value, 200,000,000 shares authorized, 131,657,369 and 110,494,245 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively		132		110
Common stock issuable, 39,595 and 0 shares as of June 30, 2023 and December 31, 2022		23		—
Additional paid-in-capital		698,897		675,841
Accumulated deficit		(680,546)		(634,233)
Total stockholders' equity attributed to the Company		18,509		41,721

Non-controlling interests		(34,452)		8,304
Total stockholders' equity (deficit)		(15,943)		50,025
Total liabilities and stockholders' equity (deficit)	$	180,719	$	294,301

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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FORTRESS BIOTECH, INC. AND SUBSIDIARIES

Unaudited Condensed Consolidated Statements of Operations

($ in thousands except for share and per share amounts)


	Three Months Ended June 30,				Six Months Ended June 30,
	2023		2022		2023		2022
Revenue
Product revenue, net	$	16,961	$	18,235	$	29,126	$	39,031
Collaboration revenue		183		577		364		1,154
Revenue - related party		31		18		66		70
Other revenue		211		56		259		2,556
Net revenue		17,386		18,886		29,815		42,811

Operating expenses
Cost of goods sold - product revenue		7,767		7,633		14,216		15,836
Research and development		32,139		33,130		67,415		69,852
Research and development - licenses acquired		3		1		4,233		1
Selling, general and administrative		24,439		29,048		49,780		55,318
Asset impairment		3,143		—		3,143		—
Total operating expenses		67,491		69,812		138,787		141,007
Loss from operations		(50,105)		(50,926)		(108,972)		(98,196)

Other income (expense)
Interest income		715		150		1,751		292
Interest expense and financing fee		(6,425)		(3,154)		(10,721)		(5,504)
Change in fair value of warrant liabilities		(512)		—		6,166		—
Loss from deconsolidation of Aevitas		(3,369)		—		(3,369)		—
Other income		395		—		699		—
Total other expense		(9,196)		(3,004)		(5,474)		(5,212)
Net loss		(59,301)		(53,930)		(114,446)		(103,408)

Net loss attributable to non-controlling interests		34,525		32,574		68,133		66,292
Net loss attributable to Fortress		(24,776)		(21,356)		(46,313)		(37,116)

Preferred A dividends declared and paid		(2,008)		(2,008)		(4,016)		(4,016)
Net loss attributable to common stockholders	$	(26,784)	$	(23,364)	$	(50,329)	$	(41,132)

Net loss per common share attributable to common stockholders - basic and diluted	$	(0.24)	$	(0.26)	$	(0.47)	$	(0.47)

Weighted average common shares outstanding - basic and diluted		110,659,985		88,743,457		106,297,241		87,593,952

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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FORTRESS BIOTECH, INC. AND SUBSIDIARIES

Unaudited Condensed Consolidated Statement of Changes in Stockholders’ Equity (Deficit)

($ in thousands except for share amounts)

For the Three Months Ended June 30, 2023



	Series A Perpetual						Common								Total
	Preferred Stock			Common Stock			Shares		Paid-In		Accumulated		Non-Controlling		Stockholders’
	Shares	Amount		Shares	Amount		Issuable		Capital		Deficit		Interests		Equity (Deficit)
Balance as of March 31, 2023	3,427,138	$	3	130,417,161	$	130	$	—	$	693,433	$	(655,770)	$	(17,990)	$	19,806
Stock-based compensation expense	—		—	—		—		—		4,217		—		—		4,217
Issuance of common stock related to equity plans	—		—	82,728		—		—		—		—		—		—
Public offering cost	—		—	—		—		—		(41)		—		—		(41)
Issuance of common stock for at-the-market offering, net	—		—	991,481		2		—		719		—		—		721
Common shares issued for dividend on partner company's convertible preferred shares	—		—	165,999		—		23		108		—		—		131
Preferred A dividends declared and paid	—		—	—		—		—		(2,008)		—		—		(2,008)
Partner company’s offering, net	—		—	—		—		—		14,460		—		—		14,460
Issuance of common stock under partner company’s ESPP	—		—	—		—		—		88		—		—		88
Partner company’s dividends declared and paid	—		—	—		—		—		(185)		—		—		(185)
Issuance of partner company’s common shares for research and development expenses	—		—	—		—		—		3		—		—		3
Partner company’s exercise of options for cash	—		—	—		—		—		3		—		—		3
Warrants	—		—	—		—		—		272		—		—		272
Deconsolidation of Aevitas non-controlling interest	—		—	—		—		—		—		—		5,891		5,891
Non-controlling interest in partner companies	—		—	—		—		—		(12,172)		—		12,172		—
Net loss attributable to non-controlling interest	—		—	—		—		—		—		—		(34,525)		(34,525)
Net loss attributable to common stockholders	—		—	—		—		—		—		(24,776)		—		(24,776)
Balance as of June 30, 2023	3,427,138	$	3	131,657,369	$	132	$	23	$	698,897	$	(680,546)	$	(34,452)	$	(15,943)

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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FORTRESS BIOTECH, INC. AND SUBSIDIARIES

Unaudited Condensed Consolidated Statement of Changes in Stockholders’ Equity

($ in thousands except for share amounts)

For the Three Months Ended June 30, 2022


	Series A Perpetual						Common								Total
	Preferred Stock			Common Stock			Shares		Paid-In		Accumulated		Non-Controlling		Stockholders’
	Shares	Amount		Shares	Amount		Issuable		Capital		Deficit		Interests		Equity
Balance as of March 31, 2022	3,427,138	$	3	106,321,875	$	106	$	—	$	660,973	$	(563,223)	$	95,719	$	193,578
Stock-based compensation expense	—		—	—		—		—		5,081		—		—		5,081
Issuance of common stock related to equity plans	—		—	176,406		—		—		—		—		—		—
Issuance of common stock under ESPP	—		—	135,464		—		—		99		—		—		99
Issuance of common stock for at-the-market offering, net	—		—	1,083,902		2		—		1,299		—		—		1,301
Preferred A dividends declared and paid	—		—	—		—		—		(2,008)		—		—		(2,008)
Partner company’s at-the-market offering, net	—		—	—		—		—		3,693		—		—		3,693
Partner company’s dividends declared and paid	—		—	—		—		—		(188)		—		—		(188)
Reversal of partner company’s common shares for research and development expenses	—		—	—		—		—		(35)		—		—		(35)
Partner company’s exercise of options for cash	—		—	—		—		—		111		—		—		111
Non-controlling interest in partner companies	—		—	—		—		—		(7,334)		—		7,334		—
Net loss attributable to non-controlling interest	—		—	—		—		—		—		—		(32,574)		(32,574)
Net loss attributable to common stockholders	—		—	—		—		—		—		(21,356)		—		(21,356)
Balance as of June 30, 2022	3,427,138	$	3	107,717,647	$	108	$	—	$	661,691	$	(584,579)	$	70,479	$	147,702

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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FORTRESS BIOTECH, INC. AND SUBSIDIARIES

Unaudited Condensed Consolidated Statement of Changes in Stockholders’ Equity (Deficit)

($ in thousands except for share amounts)

For the Six Months Ended June 30, 2023


	Series A						Common						Total
	Preferred Stock			Common Stock			Shares		Paid-In		Accumulated		Non-Controlling		Stockholders’
	Shares	Amount		Shares	Amount		Issuable		Capital		Deficit		Interests		Equity (Deficit)
Balance as of December 31, 2022	3,427,138	$	3	110,494,245	$	110	$	—	$	675,841	$	(634,233)	$	8,304	$	50,025
Stock-based compensation expense	—		—	—		—		—		8,948		—		—		8,948
Issuance of common stock related to equity plans	—		—	2,757,850		3		—		(3)		—		—		—
Issuance of common stock for public offering, net	—		—	16,642,894		17		—		13,137		—		—		13,154
Issuance of common stock for at-the-market offering, net	—		—	1,596,381		2		—		1,166		—		—