Full Press Release Details
Fortress Biotech Reports Third Quarter
2019 Financial Results and Recent Corporate Highlights
New York, NY - November 12, 2019
- Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on identifying,
in-licensing and developing high-potential marketed and development-stage drugs and drug candidates, today announced financial
results and recent corporate highlights for the third quarter ended September 30, 2019.
Lindsay A. Rosenwald, M.D., Fortress'
Chairman, President and Chief Executive Officer, said, "We are very pleased with the progress made during the third quarter
of 2019 as we continue to focus on generating shareholder value in five distinct ways - through potential revenue and balance
sheet growth, monetizations, priority review vouchers and future sales royalties. We recently acquired and launched Ximino ,
the second prescription oral antibiotic for acne in our marketed dermatology portfolio, which we expect will enable us to continue
to grow the commercial side of our business. The last quarter of 2019 is expected to be marked by the achievement of additional
milestones, notably the anticipated filing of a New Drug Application ("NDA") for IV tramadol for post-surgical pain
Dr. Rosenwald continued, "We are
also pleased that MB-107, the lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency ("XSCID"),
also known as bubble boy disease, being developed by our partner company Mustang Bio, was granted the Regenerative Medicine Advanced
Therapy ("RMAT") designation by the U.S. Food and Drug Administration ("FDA"). We look forward to the presentation
of additional clinical data on MB-107 at the upcoming 61st ASH Annual Meeting and hope to achieve regulatory agreement
with the FDA later this year to potentially expedite the development and approval of this critically needed treatment option for
XSCID (bubble boy) patients. In addition, positive interim data for cosibelimab, an anti-PD-L1 antibody, were presented at the
European Society for Medical Oncology ("ESMO") Congress 2019. The ongoing Phase 1 clinical trial of cosibelimab could
support the submission of an initial Biologics License Application ("BLA") to the FDA. We are proud of our achievements
during the third quarter and are well positioned to build on the momentum in order to continue to execute on our business plan
into 2020 and beyond."
Recent Corporate Highlights1:
Marketed Dermatology Products
MB-107 (Lentiviral Gene Therapy for
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/or partners, as dictated by context.
Cosibelimab (formerly CK-301, anti-PD-L1
MB-101 (IL13R 2-targeted CAR
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)
MB-108 (Oncolytic Virus C134)
About Fortress Biotech
Fortress Biotech, Inc. ("Fortress")
is an innovative biopharmaceutical company focused on identifying, in-licensing and developing 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) and St. Jude Children's Research 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; 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:
FORTRESS BIOTECH, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
($ in thousands except for share and per share amounts)
| September 30, | December 31, | |||||||
| 2019 | 2018 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 134,945 | $ | 65,508 | ||||
| Accounts receivable (net of allowance of $250 and $0 at September 30, 2019 and December 31, 2018, respectively) | 5,137 | 5,498 | ||||||
| Short-term investments (certificates of deposit) | 5,000 | 17,604 | ||||||
| Inventory | 941 | 678 | ||||||
| Other receivables - related party | 1,243 | 2,095 | ||||||
| Prepaid expenses and other current assets | 4,117 | 6,735 | ||||||
| Restricted cash, current | 14,929 | - | ||||||
| Current assets held for sale | - | 13,089 | ||||||
| Total current assets | 166,312 | 111,207 | ||||||
| Property and equipment, net | 12,152 | 12,019 | ||||||
| Operating lease right-of-use asset, net | 21,876 | - | ||||||
| Restricted cash | 1,145 | 16,074 | ||||||
| Long-term investment, at fair value | 11,193 | - | ||||||
| Intangible asset, net | 7,731 | 1,417 | ||||||
| Other assets | 1,179 | 276 | ||||||
| Total assets | $ | 221,588 | $ | 140,993 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable and accrued expenses | $ | 28,512 | $ | 34,067 | ||||
| Accounts payable and accrued expenses - related party | - | 149 | ||||||
| Interest payable | 1,039 | 1,232 | ||||||
| Interest payable - related party | 89 | 97 | ||||||
| Notes payable, short-term - related party (net of debt discount of $0 and $336 at September 30, 2019 and December 31, 2018, respectively) | 15,472 | 9,164 | ||||||
| Partner company convertible note, short-term, at fair value | - | 9,914 | ||||||
| Operating lease liabilities - short-term | 1,741 | - | ||||||
| Derivative warrant liability | - | 991 | ||||||
| Total current liabilities | 46,853 | 55,614 | ||||||
| Notes payable, long-term (net of debt discount of $5,728 and $4,567 at September 30, 2019 and December 31, 2018, respectively) | 68,542 | 60,425 | ||||||
| Operating lease liabilities - long-term | 24,168 | - | ||||||
| Other long-term liabilities | 7,025 | 5,211 | ||||||
| Total liabilities | 146,588 | 121,250 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity | ||||||||
| Preferred stock, $.001 par value, 15,000,000 authorized, 5,000,000 designated Series A shares, 1,026,111 and 1,000,000 shares issued and outstanding as of September 30, 2019 and December 31, 2018; liquidation value of $25.00 per share | 1 | 1 | ||||||
| Common stock, $.001 par value, 100,000,000 shares authorized, 70,335,534 and 57,845,447 shares issued and outstanding as of September 30, 2019 and December 31, 2018, respectively | 70 | 58 | ||||||
| Common stock issuable, 307,486 and 744,322 shares as of September 30, 2019 and December 31, 2018, respectively | 500 | 659 | ||||||
| Additional paid-in-capital | 445,966 | 397,408 | ||||||
| Accumulated deficit | (420,742 | ) | (396,274 | ) | ||||
| Total stockholders' equity attributed to the Company | 25,795 | 1,852 | ||||||
| Non-controlling interests | 49,205 | 17,891 | ||||||
| Total stockholders' equity | 75,000 | 19,743 | ||||||
| Total liabilities and stockholders' equity | $ | 221,588 | $ | 140,993 |
FORTRESS BIOTECH, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of
($ in thousands except for share and
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Revenue | ||||||||||||||||
| Product revenue, net | $ | 9,492 | $ | 5,168 | $ | 23,816 | $ | 17,366 | ||||||||
| Revenue - from a related party | 280 | 5 | 1,683 | 525 | ||||||||||||
| Net revenue | 9,772 | 5,173 | 25,499 | 17,891 | ||||||||||||
| Operating expenses | ||||||||||||||||
| Cost of goods sold - product revenue | 2,702 | 1,406 | 6,972 | 4,546 | ||||||||||||
| Research and development | 14,571 | 16,082 | 56,355 | 58,528 | ||||||||||||
| Research and development - licenses acquired | 700 | 3,706 | 1,350 | 3,804 | ||||||||||||
| General and administrative | 14,339 | 12,184 | 41,260 | 38,788 | ||||||||||||
| Total operating expenses | 32,312 | 33,378 | 105,937 | 105,666 | ||||||||||||
| Loss from operations | (22,540 | ) | (28,205 | ) | (80,438 | ) | (87,775 | ) | ||||||||
| Other income (expenses) | ||||||||||||||||
| Interest income | 738 | 269 | 1,955 | 841 | ||||||||||||
| Interest expense and financing fee | (3,168 | ) | (2,657 | ) | (8,743 | ) | (7,650 | ) | ||||||||
| Change in fair value of derivative liability | - | 12 | - | 114 | ||||||||||||
| Change in fair value of subsidiary convertible note | - | (84 | ) | - | 26 | |||||||||||
| Change in fair value of investments | - | (565 | ) | - | (1,390 | ) | ||||||||||
| Other loss | - | - | - | (333 | ) | |||||||||||
| Gain on deconsolidation of Caelum | - | - | 18,521 | - | ||||||||||||
| Total other income (expenses) | (2,430 | ) | (3,025 | ) | 11,733 | (8,392 | ) | |||||||||
| Loss from continuing operations | (24,970 | ) | (31,230 | ) | (68,705 | ) | (96,167 | ) | ||||||||
| Discontinued operations: | ||||||||||||||||
| Income (loss) from discontinued operations, net of tax | - | 2,643 | - | (6,354 | ) | |||||||||||
| Total income (loss) from discontinued operations | - | 2,643 | - | (6,354 | ) | |||||||||||
| Net loss | (24,970 | ) | (28,587 | ) | (68,705 | ) | (102,521 | ) | ||||||||
| Less: net loss attributable to non-controlling interests | 12,208 | 11,949 | 44,237 | 43,254 | ||||||||||||
| Net loss attributable to common stockholders | $ | (12,762 | ) | $ | (16,638 | ) | $ | (24,468 | ) | $ | (59,267 | ) | ||||
| Loss from continuing operations per common share - basic and diluted | $ | (0.44 | ) | $ | (0.70 | ) | $ | (1.29 | ) | $ | (2.21 | ) | ||||
| Income (loss) from discontinued operations per common share - basic and diluted | $ | - | $ | 0.06 | $ | - | $ | (0.15 | ) | |||||||
| Net loss per common share attributable to common stockholders - basic and diluted | $ | (0.22 | ) | $ | (0.37 | ) | $ | (0.46 | ) | $ | (1.36 | ) | ||||
| Weighted average common shares outstanding - basic and diluted | 56,856,821 | 44,818,186 | 53,060,565 | 43,578,763 |