Recent Updates
Recently added Catalysts
FBIO

Fortress Biotech Reports Record Second Quarter 2021 Financial Results and Recent Corporate Highlights Net revenue for second quarter of 2021 increased 89% year-over-year to $17.8 million, a quarterly record Rolling NDA s

Key Takeaway: Fortress Biotech Reports Record Second Quarter 2021 Financial Results and Recent Corporate Highlights Net revenue for second quarter of 2021 increased 89% year-over-year to $17.8 million, a quarterly record Rolling NDA submission for CUTX-101 for the treatment of Menkes dise

Full Press Release Details

Fortress Biotech Reports Record Second Quarter
2021 Financial Results and Recent Corporate Highlights
Net revenue for second quarter of 2021 increased
89% year-over-year to $17.8 million, a quarterly record
Rolling NDA submission for CUTX-101 for the
treatment of Menkes disease expected to begin in the second half of 2021
On track to report top-line results from
registration-enabling study of cosibelimab in metastatic cutaneous squamous cell carcinoma by year-end 2021
New York, NY - August 16, 2021 -
Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring, developing
and commercializing or monetizing promising biopharmaceutical products and product candidates cost-effectively, today announced financial
results and recent corporate highlights for the second quarter ended June 30, 2021.
Lindsay A. Rosenwald, M.D., Fortress' Chairman,
President and Chief Executive Officer, said, "We generated significant sales momentum in the second quarter, recording quarterly
record net revenues of $17.8 million, an 89% increase year-over-year. We also successfully acquired and recently launched QBREXZA
to further expand our portfolio of marketed products, as well as in-licensed Dotinurad, DFD-29, and a novel CAR T technology, which enhance
our robust pipeline of drug candidates. In addition, we presented compelling clinical data for CAEL-101 for the treatment of AL amyloidosis
and MB-106 for relapsed or refractory B-cell non-Hodgkin lymphomas ("B-NHL") and chronic lymphocytic leukemia ("CLL")
at the European Hematology Association 2021 Virtual Congress ("EHA2021"). Looking ahead, we anticipate several additional
regulatory and clinical catalysts throughout the remainder of 2021, including the availability of pivotal data from cosibelimab for the
treatment of metastatic cutaneous squamous cell carcinoma. We also expect to begin the rolling New Drug Application ("NDA")
submission for CUTX-101 for the treatment of Menkes disease in the second half of 2021."
Dr. Rosenwald continued, "We have an expanding
portfolio of seven marketed dermatology products and more than 25 product candidates across our partner companies, including 18 clinical
programs and 24 clinical trials, of which four are pivotal clinical trials, and up to four more could potentially be pivotal soon. Our
diversified business model is supported by a world-class business development team. Fortress and our partner companies are well-positioned
to achieve an array of milestones over the next year and into the future with the objective of providing new treatment options to patients
in need, while creating significant long-term value for our shareholders."
Recent Corporate Highlights1:
Marketed Dermatology Products and Product Candidates
Includes product candidates in development at Fortress, majority-owned and controlled partners and partners 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 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)
MB-107 and MB-207 (Lentiviral Gene Therapies
for X-linked Severe Combined Immunodeficiency ("XSCID"))
MB-101 (IL13R 2-targeted CAR T Cell Therapy)
Novel CAR T Technology
Dotinurad (Urate Transporter (URAT1) Inhibitor)
To assist our stockholders in understanding our
company, we have prepared non-GAAP financial results for the three months ended June 30, 2021 and 2020. These results exclude the operations
of our three public partner companies: Avenue, Checkpoint and Mustang Bio. The goal in providing these non-GAAP financial metrics is
to highlight the financial results of Fortress' core operations, which are comprised of our commercial-stage business, 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-Q that will be filed with the Securities and Exchange Commission ("SEC") on August 16, 2021, the
Company has, in this press release, included certain non-GAAP measurements. The non-GAAP net income (loss) attributable to common stockholders
is defined by the Company as GAAP net income (loss) attributable to common stockholders, less net losses attributable to common stockholders
from our public partner companies Avenue, Checkpoint and Mustang Bio. 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 income (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, Qbrexza inventory step-up and depreciation expense.
Management believes use 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 results. However, non-GAAP income (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 three months ended June 30, For the six months ended June 30,
($ in thousands except for share and per share amounts) 2021 2020 2021 2020
Net loss attributable to common stockholders $ (3,535 ) $ (13,314 ) $ (12,357 ) $ (25,684 )
Net loss attributable to common stockholders - Avenue 1 (215 ) (431 ) (440 ) (718 )
Net loss attributable to common stockholders - Checkpoint 2 (1,711 ) (1,045 ) (2,869 ) (1,798 )
Net loss attributable to common stockholders - Mustang Bio 3 (2,496 ) (3,732 ) (5,414 ) (7,332 )
Non-GAAP net income (loss) attributable to common stockholders $ 887 $ (8,106 ) $ (3,634 ) $ (15,836 )
Stock based compensation 2,921 1,844 4,811 3,584
Non-cash interest 497 1,713 707 2,482
Amortization of licenses 741 355 1,325 710
Amortization of debt discount 595 390 903 878
Depreciation 137 151 278 305
Increase in fair value of investment 4 (25,005 ) - (30,918 ) -
Change in fair value of derivative liabilities 5 3,925 - 344 -
Qbrexza inventory step-up 6 1,238 - 1,238 -
Fortress non-GAAP loss attributable to common stockholders $ (14,064 ) $ (3,653 ) $ (24,946 ) $ (7,877 )
Per common share - basic and diluted:
Net income (loss) attributable to common stockholders (GAAP) $ (0.04 ) $ (0.19 ) $ (0.15 ) $ (0.39 )
Non-GAAP net income (loss) attributable to common stockholders $ 0.01 $ (0.12 ) $ (0.04 ) $ (0.24 )
Fortress non-GAAP loss attributable to common stockholders $ (0.17 ) $ (0.05 ) $ (0.31 ) $ (0.12 )
Weighted average common shares outstanding - basic and diluted 80,962,994 68,550,494 80,907,671 66,023,367
Reconciliation to non-GAAP research and development
and selling, general and administrative costs:
For the quarter ended June 30, For the six months ended June 30,
($ in thousands) 2021 2020 2021 2020
Research and development 1 $ 33,834 $ 17,273 $ 53,988 $ 32,390
Less:
Research and development Avenue 328 1,219 586 1,916
Research and development Checkpoint 7,198 3,029 11,411 5,664
Research and development Mustang Bio 2 11,840 9,771 23,395 19,023
Non-GAAP research and development costs $ 14,468 $ 3,254 $ 18,596 $ 5,787
Selling, general and administrative $ 19,382 $ 14,456 $ 36,924 $ 29,975
Less:
Selling, general and administrative Avenue 623 684 1,366 1,261
Selling, general and administrative Checkpoint 3 1,736 1,496 3,350 3,049
Selling, general and administrative Mustang Bio 4 2,086 1,917 4,296 3,685
Non-GAAP selling, general and administrative costs $ 14,937 $ 10,359 $ 27,912 $ 21,980
About Fortress Biotech
Fortress Biotech, Inc. ("Fortress")
is an innovative biopharmaceutical company that was ranked in Deloitte's 2019 and 2020 Technology Fast 500 , annual rankings
of the fastest-growing North American companies in the technology, media, telecommunications, life sciences and energy tech sectors,
based on percentages of fiscal year revenue growth over three-year periods. Fortress is focused on acquiring, developing and commercializing
high-potential marketed and development-stage drugs and drug candidates. The company has seven marketed prescription pharmaceutical products
and over 25 programs in development at Fortress, at its majority-owned and majority-controlled partners and at partners it founded and
in which it holds significant minority ownership positions. Such product candidates span six large-market areas, including oncology,
rare diseases and gene therapy, which allow it to create value for shareholders. Fortress advances its diversified pipeline through a
streamlined operating structure that fosters efficient drug development. The Fortress model is driven by a world-class business development
team that is focused on leveraging its significant biopharmaceutical industry expertise to further expand the company's portfolio
of product opportunities. Fortress has established partnerships with some of the world's leading academic research institutions
and biopharmaceutical companies to maximize each opportunity to its full potential, including Alexion Pharmaceuticals, Inc., AstraZeneca,
City of Hope, Fred Hutchinson Cancer Research Center, St. Jude Children's Research Hospital, Nationwide Children's Hospital
and Sentynl Therapeutics, Inc. For more information, visit www.fortressbiotech.com.
Forward-Looking Statements
This press release may contain "forward-looking
statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934,
as amended. As used below and throughout this press release, the words "we", "us" and "our" may refer
to Fortress individually or together with one or more partner companies, as dictated by context. Such statements include, but are not
limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical
facts. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that
could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results
to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under
and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities;
uncertainties relating to preclinical and clinical testing; risks relating to the timing of starting and completing clinical trials; our
Last updated: Aug 16, 2021