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Fortress Biotech Reports Second Quarter 2020 Financial Results and Recent Corporate Highlights Product revenue for the first six months of 2020 increased 50% year-over-year to $21.4 million Agreement executed with Columb

Key Takeaway: Fortress Biotech Reports Second Quarter 2020 Financial Results and Recent Corporate Highlights Product revenue for the first six months of 2020 increased 50% year-over-year to $21.4 million Agreement executed with Columbia University to develop novel oligonucleotide platform

Full Press Release Details

Fortress Biotech Reports Second Quarter
2020 Financial Results and Recent Corporate Highlights
Product revenue for the first six
months of 2020 increased 50% year-over-year to $21.4 million
Agreement executed with Columbia University
to develop novel oligonucleotide platform for the treatment of genetically driven cancers, including KRAS-driven cancers, and coronaviruses
New York, NY - August 10, 2020
- Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative revenue-generating 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, 2020.
Lindsay A. Rosenwald, M.D., Fortress'
Chairman, President and Chief Executive Officer, said, "Fortress has continued to efficiently and effectively execute on
its growth objectives due to our unique business model. We are proud to have generated total net revenue of $21.4 million from
our five marketed pharmaceutical products in the first half of 2020, a year-over-year increase of 50%, despite this unprecedented
time. Moreover, during the second quarter, we acquired a broad platform technology from Columbia University to effectively deliver
novel, proprietary oligonucleotides for the treatment of genetically driven cancers, with an initial target of KRAS-driven cancers.
We are also exploring the potential of the platform to treat novel coronaviruses, such as COVID-19."
continued, "Additionally, we continue to work with our partner companies to steadily build and advance our growing portfolio
of commercial and development-stage product candidates. Our goal is to increase intrinsic value for our shareholders. In the second
half of 2020, we look forward to a multitude of key inflection points, including: additional data from our registration-enabling
clinical trial of cosibelimab in patients with metastatic cutaneous squamous cell carcinoma ("mCSCC"), the PDUFA date
for IV tramadol in October and initiating the rolling submission of the New Drug Application ("NDA") to the U.S. Food
and Drug Administration ("FDA") for CUTX-101 for the treatment of Menkes disease. We also anticipate the potential
launch of four more registration-enabling clinical trials this year, two CAEL-101 pivotal trials for AL amyloidosis and two MB-107
and MB-207 lentiviral gene therapy clinical trials for newly diagnosed infants and previously transplanted patients with X-linked
severe combined immunodeficiency ("XSCID")."
Marketed Dermatology Products
1 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
Cosibelimab (anti-PD-L1 antibody)
CAEL-101 (light chain fibril-reactive
monoclonal antibody for AL amyloidosis)
MB-107 and MB-207 (lentiviral gene therapies
MB-104 (CS1-targeted CAR T cell therapy)
ONCOlogues (proprietary platform technology
using PNA oligonucleotides)
To assist our stockholders in understanding
our company, we have prepared non-GAAP financial results for the three months and six months ended June 30, 2020 and 2019. These
results exclude the operations of our three public partner companies: Avenue Therapeutics, Inc. ("Avenue"), Checkpoint
Therapeutics, Inc. ("Checkpoint") and Mustang Bio, Inc. ("Mustang"), as well as any one-time, non-recurring,
non-cash transactions, such as the gain of $18.4 million we recorded in the first quarter of 2019 resulting from the de-consolidation
of Caelum Biosciences, Inc. ("Caelum"). 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 filed with the Securities and Exchange Commission ("SEC") on August 10, 2020, the Company,
in this press release, has included certain non-GAAP measurements. The non-GAAP loss attributable to common stockholders is defined
by the Company as GAAP net loss attributable to common stockholders, less net losses from our public partner companies Avenue,
Checkpoint, and Mustang, as well as 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, and depreciation.
Management believes 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 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,
2020 2019 2020 2019
Net income (loss) attributable to common stockholders $ (13,314 ) $ (13,098 ) $ (25,684 ) $ (11,706 )
Net (Loss) income attributable to common stockholders - Avenue 1 (431 ) (1,810 ) (718 ) (5,079 )
Net (Loss) income attributable to common stockholders - Checkpoint 2 (1,045 ) (1,433 ) (1,798 ) (3,257 )
Net (Loss) income attributable to common stockholders - Mustang 3 (3,732 ) (3,144 ) (7,332 ) (6,838 )
Net (Loss) income attributable to common stockholders - Caelum 4 - 137 - 18,521
Non-GAAP net loss attributable to common stockholders $ (8,106 ) $ (6,848 ) $ (15,836 ) $ (15,053 )
Stock based compensation 1,844 1,403 3,584 2,731
Non-cash interest 1,713 2,057 2,482 2,793
Amortization of licenses 355 212 710 446
Amortization of debt discount 390 667 878 1,289
Depreciation 151 157 305 350
Fortress non-GAAP loss attributable to common stockholders $ (3,653 ) $ (2,352 ) $ (7,877 ) $ (7,444 )
GAAP net loss $ (0.19 ) $ (0.24 ) $ (0.39 ) $ (0.23 )
Non-GAAP net loss $ (0.12 ) $ (0.13 ) $ (0.24 ) $ (0.29 )
FBIO non-GAAP $ (0.05 ) $ (0.04 ) $ (0.12 ) $ (0.15 )
WASO 68,550,494 53,726,125 66,023,367 51,130,977
Reconciliation to non-GAAP research and
development and general and administrative costs:
For the three months ended June 30, For the six months ended June 30,
($ in thousands) 2020 2019 2020 2019
Research and development $ 15,703 $ 18,511 $ 30,570 $ 41,784
Less:
Research and development Avenue 1,219 6,392 1,916 16,633
Research and development Checkpoint 3,029 4,120 5,664 8,701
Research and development Mustang 1 9,771 6,761 19,023 13,659
Non-GAAP research and development costs $ 1,684 $ 1,238 $ 3,967 $ 2,791
General and administrative $ 14,456 $ 13,443 $ 29,975 $ 26,921
Less:
General and administrative Avenue 684 716 1,261 1,835
General and administrative Checkpoint 2 1,496 1,536 3,049 3,105
General and administrative Mustang 3 1,917 1,841 3,685 4,122
Non-GAAP general and administrative costs $ 10,359 $ 9,350 $ 21,980 $ 17,859
About Fortress Biotech
Inc. ("Fortress") is an innovative biopharmaceutical company that was recently ranked number 10 in Deloitte's
2019 Technology Fast 500 , an annual ranking of the fastest-growing North American companies in the technology, media, telecommunications,
life sciences and energy tech sectors, based on percentage of fiscal year revenue growth over a three-year period. Fortress is
focused on acquiring, developing and commercializing high-potential marketed and development-stage drugs and drug candidates.
The company has five 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, InvaGen Pharmaceuticals Inc. (a subsidiary of Cipla Limited), St. Jude Children's Research Hospital and
Nationwide Children's Hospital. 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 dependence on third-party suppliers; risks relating to the COVID-19 outbreak and
its potential impact on our employees' and consultants' ability to complete work in a timely manner and on our ability
to obtain additional financing on favorable terms or at all; our ability to attract, integrate and retain key personnel; the early
Last updated: Aug 10, 2020