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Fortress Biotech Reports Record 2021 Financial Results and Recent Corporate Highlights Record 2021: Net revenue of $68.8 million and proceeds from the successful monetization of our investment in Caelum Biosciences of $5

Key Takeaway: Fortress Biotech Reports Record 2021 Financial Results and Recent Corporate Highlights 2021: Net revenue of $68.8 million and proceeds from the successful monetization of our investment in Caelum Biosciences of $56.9 million1 net loss attributable to common stockholders on a G

Full Press Release Details

Fortress Biotech Reports Record 2021 Financial
Results and Recent Corporate Highlights
2021: Net revenue of $68.8 million and proceeds from the successful monetization of our investment in Caelum Biosciences of $56.9 million1
net loss attributable to common stockholders on a GAAP basis was $(64.7) million or $(0.79) per share; 2021 non-GAAP income attributable
to common stockholders of $25.5 million or $0.25 per share, as per the non-GAAP tables below
Positive top-line results from registration-enabling
study of cosibelimab in metastatic cutaneous squamous cell carcinoma announced in January 2022; BLA submission expected in 2022
Cyprium Therapeutics, a Fortress subsidiary,
and Sentynl Therapeutics, a wholly owned subsidiary of Zydus Lifesciences Ltd., signed a Development and Asset Purchase Agreement for
CUTX-101 for the treatment of Menkes disease
Rolling NDA submission for CUTX-101 for the
treatment of Menkes disease is expected to be completed in mid-2022
Journey Medical Corporation, a Fortress partner
company, completed an initial public offering yielding net proceeds of $30.6 million
Miami, FL - March 28, 2022 -
Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on efficiently acquiring,
developing and commercializing or monetizing promising therapeutic products and product candidates, today announced financial results
and recent corporate highlights for the full-year ended December 31, 2021.
Lindsay A. Rosenwald, M.D., Fortress' Chairman,
President and Chief Executive Officer, said, "Fortress and its partner companies had an exceptional year in 2021, generating a
record-setting annual net revenue of $68.8 million, representing more than 50% growth over 2020. We also began to realize the value of
our monetization strategy when AstraZeneca acquired Caelum Biosciences ("Caelum"), a company founded by Fortress, during
the fourth quarter of 2021, when we received a $56.9 million payment for our investment in Caelum. Fortress has the potential to receive
up to an additional approximately $155 million in future milestone payments from the transaction, which includes proceeds from the release
of escrow funds. Our subsidiary Cyprium Therapeutics ("Cyprium") executed an agreement with Sentynl Therapeutics to commit
development funding for and contingently acquire Cyprium's proprietary rights to CUTX-101, its Copper Histidinate product candidate
for the treatment of Menkes disease, upon FDA approval. Also of note, Journey Medical Corporation ("Journey Medical") completed
its $30.6 million initial public offering ("IPO"), net of discounts and other offering costs, launched Accutane (isotretinoin),
acquired Qbrexza (glycopyrronium) from Dermira, Inc. and entered into a collaboration agreement with Dr. Reddy's Laboratories
Ltd. to develop and commercialize DFD-29 (minocycline modified release capsules 40 mg) for the treatment of rosacea."
Figure is net of miscellaneous transaction expenses and a 10% holdback for an indemnification escrow.
Dr. Rosenwald continued, "Looking ahead
in 2022, we anticipate continued progress and growth from our nine marketed prescription pharmaceutical products and over 30 product candidates
in development. We have 30 ongoing clinical trials, including four product candidates in seven2
ongoing pivotal clinical trials. We expect the rolling submission of the New Drug Application ("NDA") for CUTX-101 to be complete
in mid-2022. After announcing positive top-line results from the registration-enabling study of cosibelimab in metastatic cutaneous squamous
cell carcinoma ("cSCC") in January, our partner company Checkpoint Therapeutics, Inc. ("Checkpoint") intends to
submit a Biologics License Application ("BLA") for cosibelimab in 2022, followed thereafter by a Marketing Authorization Application
submission in Europe. Mustang Bio, Inc. ("Mustang Bio"), another one of our partner companies, plans to initiate a multicenter
Phase 1/2 clinical trial investigating the safety and efficacy of MB-106, a CD20-targeted, autologous CAR T cell therapy for relapsed
or refractory B-cell non-Hodgkin lymphomas ("B-NHL") and chronic lymphocytic leukemia ("CLL") in the first half
of 2022. Mustang Bio also plans to enroll the first patient in a pivotal multicenter Phase 2 clinical trial to evaluate MB-107, a lentiviral
gene therapy for the treatment of infants under the age of two with X-linked severe combined immunodeficiency ("XSCID") in
the second half of 2022. This ongoing advancement showcases the ability of Fortress' business model to generate value for our shareholders
and develop innovative therapies to help patients with unmet needs across multiple disease areas."
2021 and Recent Corporate Highlights3:
Marketed Dermatology Products and Product Candidates
Includes two trials at partner company Caelum Biosciences, which was sold to AstraZeneca in October 2021 and with respect to which Fortress
remains eligible to receive up to approximately $155 million in future milestone payments from the transaction.
Includes product candidates in development at Fortress, majority-owned and controlled partners and/or subsidiaries, and partners and/or
subsidiaries in which Fortress holds significant minority ownership positions. As used herein, the words "we", "us"
and "our" may refer to Fortress individually or together with our affiliates, subsidiaries, and partners, as dictated by context.
CUTX-101 (Copper Histidinate for Menkes disease)
CAEL-101 (Light Chain Fibril-reactive Monoclonal
Antibody for AL Amyloidosis)
Cosibelimab (formerly CK-301, an anti-PD-L1
Olafertinib (formerly CK-101, a third-generation
epidermal growth factor receptor ("EGFR") inhibitor)
MB-106 (CD20-targeted CAR T Cell Therapy)
Dotinurad (Urate Transporter (URAT1) Inhibitor)
MB-107 and MB-207 (Lentiviral Gene Therapies
Triplex (Cytomegalovirus ("CMV")
MB-101 (IL13R 2-targeted CAR T Cell Therapy)
MB-105 (PSCA-targeted CAR T Cell Therapy)
MB-109 (MB-101 (IL13R 2-targeted CAR
T Cell Therapy) + MB-108 oncolytic virus)
Novel CAR T Technology
Ex Vivo Lentiviral Gene Therapy for
RAG1 Severe Combined Immunodeficiency ("RAG1-SCID")
To assist our stockholders in understanding our
company, we have prepared non-GAAP financial results for the three months and twelve months ended December 31, 2021 and 2020. These results
exclude the operations of our four public partner companies: Avenue Therapeutics, Inc. ("Avenue"), Checkpoint, Journey Medical
and Mustang Bio, as well as any one-time, non-recurring, non-cash transactions. The goal in providing these non-GAAP financial metrics
is to highlight the financial results of Fortress' core operations, which are comprised of our privately held development-stage
entities, as well as our business development and finance functions.
Use of Non-GAAP Measures:
In addition to the GAAP financial measures as
presented in our Form 10-K filed with the Securities and Exchange Commission ("SEC") on March 28, 2022, the Company, in this
press release, has included certain non-GAAP measurements. The non-GAAP net loss attributable to common stockholders is defined by the
Company as GAAP net loss attributable to common stockholders, less net losses attributable to common stockholders from our public partner
companies Avenue, Checkpoint, Journey Medical and Mustang Bio ("public partner companies"), as well as our former subsidiary,
Caelum. In addition, the Company has also provided a Fortress non-GAAP loss attributable to common stockholders which is a modified EBITDA
calculation that starts with the non-GAAP loss attributable to common stockholders and removes stock-based compensation expense, non-cash
interest expense, amortization of licenses and debt discount, changes in fair values of investment, changes in fair value of derivative
liability, and depreciation expense. The Company also provides non-GAAP research and development costs, defined as GAAP research and development
costs, less research and development costs of our public partner companies and non-GAAP selling, general and administrative costs, defined
as GAAP selling, general and administrative costs, less selling, general and administrative costs of our public partner companies.
Management believes each of these non-GAAP measures
provide meaningful supplemental information regarding the Company's performance because (i) it allows for greater transparency with respect
to key measures used by management in its financial and operational decision-making; (ii) it excludes the impact of non-cash or, when
specified, non-recurring items that are not directly attributable to the Company's core operating performance and that may obscure trends
in the Company's core operating performance; and (iii) it is used by institutional investors and the analyst community to help analyze
the Company's standalone results separate from the results of its public partner companies. However, non-GAAP loss attributable to common
stockholders and any other non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior
to, the corresponding measures calculated in accordance with GAAP. Further, non-GAAP financial measures used by the Company and the manner
in which they are calculated may differ from the non-GAAP financial measures or the calculations of the same non-GAAP financial measures
used by other companies, including the Company's competitors.
The tables below provide a reconciliation from
GAAP to non-GAAP measures:
For the year ended December 31,
($ in thousands except for share and per share amounts) 2021 2020 1
Net loss attributable to common stockholders $ (64,703 ) $ (46,526 )
Net loss attributable to common stockholders - Avenue 2 (822 ) (1,177 )
Net loss attributable to common stockholders - Checkpoint 3 (9,313 ) (3,798 )
Net (loss) income attributable to common stockholders - Journey Medical 4 (36,708 ) 6,662
Net loss attributable to common stockholders - Mustang 5 (11,256 ) (13,066 )
Non-GAAP loss attributable to common stockholders $ (6,605 ) $ (35,147 )
Stock based compensation 10,133 6,821
Amortization of debt discount 3,914 3,301
Depreciation 462 603
Increase in fair value of investment in Caelum (39,294 ) (6,418 )
Realization in Caelum investment 6 56,860 -
Fortress non-GAAP income (loss) attributable to common stockholders $ 25,469 $ (30,840 )
Per common share - basic and diluted:
Net loss attributable to common stockholders (GAAP) $ (0.79 ) $ (0.65 )
Non-GAAP net loss attributable to common stockholders $ (0.08 ) $ (0.49 )
Fortress non-GAAP income (loss) attributable to common stockholders - basic $ 0.31 $ (0.43 )
Fortress non-GAAP income (loss) attributable to common stockholders - diluted $ 0.25 n/a
Weighted average common shares outstanding - basic 81,700,220 72,005,181
Weighted average common shares outstanding - diluted 103,604,466 72,005,181
Last updated: Mar 28, 2022