Full Press Release Details
Fortress Biotech Reports Record 2020 Financial
Results and Recent Corporate Highlights
Revenue from marketed dermatology products
increased 28% for full-year 2020 compared to 2019
Our partner company, Cyprium Therapeutics,
and Sentynl Therapeutics, a wholly-owned subsidiary of the Zydus Group, 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 begin in the second half of 2021
New York, NY - March 31, 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 full-year ended December 31, 2020.
Lindsay A. Rosenwald, M.D., Fortress' Chairman,
President and Chief Executive Officer, said, "We are delighted with our continued progress, and achievement of significant milestones
throughout 2020 and in recent months. Notably, our partner company, Cyprium Therapeutics ("Cyprium"), and Sentynl Therapeutics,
a wholly-owned subsidiary of the Zydus Group, signed a Development and Asset Purchase Agreement for CUTX-101 for the treatment of Menkes
disease, in February 2021. Also, our full-year 28% revenue growth during the pandemic shows the resilience of the Fortress business model.
Since the company's management took over in 2014, Fortress and our partner companies have built a growing portfolio of six marketed
dermatologic pharmaceutical products and more than 25 product candidates in our pipeline across multiple therapeutic categories, including
oncology, gene therapy, dermatology, and rare diseases. We are on track to submit our second New Drug Application ("NDA")
to the U.S. Food and Drug Administration ("FDA") later this year."
Dr. Rosenwald continued, "As we look ahead
to 2021, Fortress expects to deliver further top-line growth through a diversified, long-term revenue stream, and we and our partner companies
anticipate multiple key value-creating milestones throughout the year. We have four product candidates in five ongoing pivotal clinical
trials, with multiple other earlier-stage clinical trials progressing as well. Additionally, we intend to continue to in-license promising
drugs and drug candidates, and to seek partners for late-stage programs to maximize each opportunity to its full potential. We continue
to demonstrate the ability of our business model to generate meaningful value creation opportunities with the potential to produce life-changing
therapies for people in need."
2020 and Recent Corporate Highlights1:
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 disease)
CAEL-101 (Light Chain Fibril-reactive Monoclonal
Antibody for AL Amyloidosis)
Cosibelimab (formerly CK-301, an anti-PD-L1
CK-101 (Third-generation Epidermal Growth Factor
Receptor ("EGFR") Inhibitor)
MB-107 and MB-207 (Lentiviral Gene Therapies
MB-106 (CD20-targeted CAR T Cell Therapy)
MB-102 (CD123-targeted CAR T Cell Therapy)
MB-101 (IL13R 2-targeted CAR T Cell Therapy)
MB-105 (PSCA-targeted CAR T Cell Therapy)
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 twelve months ended December 31, 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 deconsolidation 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-K filed with the Securities and Exchange Commission ("SEC") on March 31, 2021, 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, 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, changes in fair values
of investment, changes in fair value of derivative liability, and depreciation expense.
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 year ended December 31, | ||||||||
| ($ in thousands) | 2020 | 2019 | ||||||
| Net income (loss) attributable to common stockholders | $ | (46,526 | ) | $ | (39,960 | ) | ||
| Net (Loss) income attributable to common stockholders - Avenue 1 | (1,177 | ) | (6,897 | ) | ||||
| Net (Loss) income attributable to common stockholders - Checkpoint 2 | (3,798 | ) | (6,280 | ) | ||||
| Net (Loss) income attributable to common stockholders - Mustang 3 | (13,065 | ) | (13,578 | ) | ||||
| Deconsolidation of Caelum Biosciences | - | 18,476 | ||||||
| Non-GAAP net loss attributable to common stockholders | $ | (28,486 | ) | $ | (31,681 | ) | ||
| Stock based compensation | 6,974 | 5,564 | ||||||
| Non-cash interest | 8,099 | 7,007 | ||||||
| Amortization of licenses | 1,420 | 1,174 | ||||||
| Amortization of debt discount | 3,301 | 2,611 | ||||||
| Depreciation | 603 | 664 | ||||||
| Increase in fair value of investment 4 | (6,418 | ) | - | |||||
| Change in fair value of derivative liability 5 | 1,189 | - | ||||||
| Fortress non-GAAP loss attributable to common stockholders | $ | (13,318 | ) | $ | (14,661 | ) | ||
| Per common share - basic and diluted: | ||||||||
| Net income (loss) attributable to common stockholders (GAAP) | $ | (0.65 | ) | $ | (0.73 | ) | ||
| Non-GAAP net loss attributable to common stockholders | $ | (0.40 | ) | $ | (0.58 | ) | ||
| Fortress non-GAAP loss attributable to common stockholders | $ | (0.18 | ) | $ | (0.27 | ) | ||
| Weighted average common shares outstanding - basic and diluted | 72,005,181 | 54,711,838 |
Reconciliation to non-GAAP research and development
and general and administrative costs:
| For the year ended December 31, | ||||||||
| ($ in thousands) | 2020 | 2019 | ||||||
| Research and development 1 | $ | 64,108 | $ | 81,326 | ||||
| Less: | ||||||||
| Research and development Avenue | 2,866 | 22,194 | ||||||
| Research and development Checkpoint 2 | 11,735 | 16,815 | ||||||
| Research and development Mustang 3 | 39,475 | 31,142 | ||||||
| Non-GAAP research and development costs | $ | 10,032 | $ | 11,175 | ||||
| Selling, general and administrative | $ | 61,166 | $ | 55,590 | ||||
| Less: | ||||||||
| General and administrative Avenue | 2,347 | 3,071 | ||||||
| General and administrative Checkpoint 4 | 6,518 | 5,996 | ||||||
| General and administrative Mustang 5 | 6,810 | 7,659 | ||||||
| Non-GAAP selling, general and administrative costs | $ | 45,491 | $ | 38,864 |
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 six 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 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