Full Press Release Details
Fortress Biotech Reports Record Fourth
Quarter and Full-Year 2019 Financial Results and Recent Corporate Highlights
Revenue from marketed dermatology
products increased 85% for fourth quarter 2019 and 49% for full-year 2019 compared to 2018
NDA for IV tramadol accepted for review
by FDA; PDUFA date is set for October 10, 2020
Rolling NDA submission for CUTX-101
for the treatment of Menkes disease is on track to begin in the fourth quarter of 2020
York, NY - March 16, 2020 - Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative
biopharmaceutical company, today announced financial results and recent corporate highlights for the fourth quarter and full year
ended December 31, 2019.
Fortress achieved multiple key milestones
in 2019 and early 2020, including:
A. Rosenwald, M.D., Fortress' Chairman, President and Chief Executive Officer, said, "We have generated significant
momentum throughout 2019 and into early 2020. In order to drive our next phase of growth, our world-class business development
team continues to identify and acquire high-potential marketed and development-stage assets to further expand our portfolio of
product opportunities. Additionally, Fortress and our development partners continue to advance our clinical-stage programs across
multiple therapeutic categories. With five commercial products and over 25 programs in development, we aim to continue to meaningfully
increase value and decrease overall risk for Fortress shareholders. Looking ahead, we expect 2020 to be a record revenue-generating
year and a transformational one for many of the development-stage programs across Fortress and our partner companies. Finally,
we look forward to continued acquisitions of marketable dermatology drugs and in-licenses of development-stage drug candidates."
Marketed Dermatology Products
MB-107 (Lentiviral Gene Therapy for
Cosibelimab (formerly CK-301, an anti-PD-L1
CK-101 (third-generation EGFR inhibitor)
MB-102 (CD123-targeted CAR T cell therapy)
MB-101 (IL13R 2-targeted CAR
MB-108 (Oncolytic Virus C134)
MB-104 (CS1-targeted CAR T cell therapy)
MB-103 (HER2-targeted CAR T cell therapy)
MB-105 (Prostate Stem Cell Antigen
(PSCA)-targeted CAR T cell therapy)
MB-106 (CD20-targeted CAR T cell therapy)
BAER-101 (novel 2/3-subtype-selective
GABA A positive allosteric modulator ["PAM"])
About Fortress Biotech
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 therapeutic areas, including oncology, rare diseases and gene therapy, which allow it
to create value while mitigating risk 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., 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
stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual
property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking
to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations
or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law. The
information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply
to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other
instance of such information appearing herein.
Jaclyn Jaffe and William Begien
Fortress Biotech, Inc.
Investor Relations Contact:
LifeSci Advisors, LLC
Media Relations Contact:
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.
FORTRESS BIOTECH, INC. AND SUBSIDIARIES
Consolidated Balance Sheets
($ in thousands except for share and
| December 31, | ||||||||
| 2019 | 2018 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 136,858 | $ | 65,508 | ||||
| Accounts receivable (net of allowance for doubtful accounts of $100 and $0 at December 31, 2019 and December 31, 2018, respectively) | 13,539 | 5,498 | ||||||
| Short-term investments (certificates of deposit) | - | 17,604 | ||||||
| Inventory | 857 | 678 | ||||||
| Other receivables - related party | 865 | 2,095 | ||||||
| Prepaid expenses and other current assets | 4,133 | 6,735 | ||||||
| Current assets held for sale | - | 13,089 | ||||||
| Total current assets | 156,252 | 111,207 | ||||||
| Property and equipment, net | 12,433 | 12,019 | ||||||
| Operating lease right-of-use asset, net | 21,480 | - | ||||||
| Restricted cash | 16,574 | 16,074 | ||||||
| Long-term investment, at fair value | 11,148 | - | ||||||
| Intangible asset, net | 7,377 | 1,417 | ||||||
| Other assets | 1,158 | 276 | ||||||
| Total assets | $ | 226,422 | $ | 140,993 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable and accrued expenses | $ | 35,451 | $ | 34,067 | ||||
| Accounts payable and accrued expenses - related party | - | 149 | ||||||
| Interest payable | 1,042 | 1,232 | ||||||
| Interest payable - related party | 92 | 97 | ||||||
| Notes payable, short-term (net of debt discount of $0 and $336 at December 31, 2019 and December 31, 2018, respectively) | 7,220 | 9,164 | ||||||
| Partner company convertible note, short-term, at fair value | - | 9,914 | ||||||
| Operating lease liabilities - short-term | 1,784 | - | ||||||
| Derivative warrant liability | 27 | 991 | ||||||
| Total current liabilities | 45,616 | 55,614 | ||||||
| Notes payable, long-term (net of debt discount of $5,086 and $4,567 at December 31, 2019 and December 31, 2018, respectively) | 77,436 | 60,425 | ||||||
| Operating lease liabilities - long-term | 23,712 | - | ||||||
| Other long-term liabilities | 7,126 | 5,211 | ||||||
| Total liabilities | 153,890 | 121,250 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity | ||||||||
| Preferred stock, $.001 par value, 15,000,000 authorized, 5,000,000 designated Series A shares, 1,341,167 and 1,000,000 shares issued and outstanding as of December 31, 2019 and December 31, 2018, respectively; liquidation value of $25.00 per share | 1 | 1 | ||||||
| Common stock, $.001 par value, 100,000,000 shares authorized, 74,027,425 and 57,845,447 shares issued and outstanding as of December 31, 2019 and December 31, 2018, respectively | 74 | 58 | ||||||
| Common stock issuable, 251,337 and 744,322 shares as of December 31, 2019 and December 31, 2018, respectively | 500 | 659 | ||||||
| Additional paid-in-capital | 461,874 | 397,408 | ||||||
| Accumulated deficit | (436,234 | ) | (396,274 | ) | ||||
| Total stockholders' equity attributed to the Company | 26,215 | 1,852 | ||||||
| Non-controlling interests | 46,317 | 17,891 | ||||||
| Total stockholders' equity | 72,532 | 19,743 | ||||||
| Total liabilities and stockholders' equity | $ | 226,422 | $ | 140,993 |
FORTRESS BIOTECH, INC. AND SUBSIDIARIES
Consolidated Statements of Operations
($ in thousands except for share and
| For the Years Ended December 31, | ||||||||
| 2019 | 2018 | |||||||
| Revenue | ||||||||
| Product revenue, net | $ | 34,921 | $ | 23,376 | ||||
| Revenue - from a related party | 1,708 | 3,506 | ||||||
| Net revenue | 36,629 | 26,882 | ||||||
| Operating expenses | ||||||||
| Cost of goods sold - product revenue | 10,532 | 6,125 | ||||||
| Research and development | 75,236 | 83,333 | ||||||
| Research and development - licenses acquired | 6,090 | 4,050 | ||||||
| General and administrative | 55,590 | 53,371 | ||||||
| Total operating expenses | 147,448 | 146,879 | ||||||
| Loss from operations | (110,819 | ) | (119,997 | ) | ||||
| Other income (expense) | ||||||||
| Interest income | 2,559 | 1,104 | ||||||
| Interest expense and financing fee | (11,849 | ) | (10,340 | ) | ||||
| Change in fair value of derivative liability | (27 | ) | (682 | ) | ||||
| Change in fair value of subsidiary convertible note | - | 437 | ||||||
| Change in fair value of investments | - | (1,390 | ) | |||||
| Gain on deconsolidation of Caelum | 18,476 | - | ||||||
| Other income | - | 68 | ||||||
| Total other income (expense) | 9,159 | (10,803 | ) | |||||
| Loss from continuing operations | (101,660 | ) | (130,800 | ) | ||||
| Discontinued operations: | ||||||||
| Gain from disposal of National | - | 2,333 | ||||||
| Loss from discontinued operations, net of tax | - | (13,469 | ) | |||||
| Total loss from discontinued operations | - | (11,136 | ) | |||||
| Net loss | (101,660 | ) | (141,936 | ) | ||||
| Less: net loss attributable to non-controlling interests | 61,700 | 57,789 | ||||||
| Net loss attributable to common stockholders | $ | (39,960 | ) | $ | (84,147 | ) | ||
| Loss from continuing operations per common share - basic and diluted | $ | (1.86 | ) | $ | (3.01 | ) | ||
| Loss from discontinued operations per common share - basic and diluted | $ | - | $ | (0.26 | ) | |||
| Net loss per common share attributable to common stockholders - basic and diluted | $ | (0.73 | ) | $ | (1.94 | ) | ||
| Weighted average common shares outstanding - basic and diluted | 54,711,838 | 43,461,978 |