Full Press Release Details
Biotech Reports Record First Quarter 2020 Financial Results and Recent Corporate Highlights
quarter 2020 product revenue increased 95% year-over-year to $11.9 million
IV tramadol accepted for review by FDA; assigned PDUFA date of October 10, 2020
executed with Columbia University to develop a broad platform technology to effectively deliver novel, proprietary oligonucleotides
to bind and directly disable mutant DNA with an initial target of KRAS-driven cancers; platform is also being explored as a potential
treatment for coronaviruses
NY - May 11, 2020 - Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative biopharmaceutical
company, today announced financial results and recent corporate highlights for the first quarter ended March 31, 2020.
Rosenwald, M.D., Fortress' Chairman, President and Chief Executive Officer, said, "The first quarter of 2020 was another
record revenue quarter for Fortress Biotech. Revenue from our dermatology products marketed by our partner company, Journey Medical
Corporation, increased 95% compared to the first quarter of 2019, demonstrating the strength of our commercial operations. We
intend to acquire one to two new prescription products this year."
continued, "We also made significant progress across our robust pipeline of development-stage product candidates in the
first quarter. Notably, IV tramadol was assigned a PDUFA date of October 10, 2020. If IV tramadol is approved by the FDA and Avenue
Therapeutics is acquired, we would expect to realize approximately $48 million, plus future contingent value rights. After a strong
start to the year, we look forward to delivering key value-creating catalysts throughout the rest of 2020."
Corporate Highlights1:
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.
(formerly CK-301, an anti-PD-L1 antibody)
MB-107 (Lentiviral Gene Therapy for
MB-105 (PSCA-targeted
MB-106 (CD20-targeted CAR T cell therapy)
ONCOlogues (proprietary platform technology
using PNA oligonucleotides)
stockholders in understanding our company, we have prepared non-GAAP financial results for the three months ended March 31, 2020
and 2019. These results exclude the operations of our three public partner companies: Avenue Therapeutics, Inc., Checkpoint Therapeutics,
Inc. and Mustang Bio, Inc., 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. 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:
to the GAAP financial measures as presented in our Form 10-Q filed with the SEC on May 11, 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 Therapeutics, Inc.
(ATXI), Checkpoint Therapeutics, Inc. (CKPT) and Mustang Bio, Inc. (MBIO). 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, debt
discount and depreciation.
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.
below provide a reconciliation from GAAP to non-GAAP measures:
| For the three months ended March 31, | ||||||||
| ($ in thousands, except for share and per share amounts) | 2020 | 2019 | ||||||
| Net (loss) income attributable to common stockholders | $ | (12,370 | ) | $ | 1,392 | |||
| Net (loss) income attributable to common stockholders - Avenue 1 | (287 | ) | (3,269 | ) | ||||
| Net (loss) income attributable to common stockholders - Checkpoint 2 | (753 | ) | (1,824 | ) | ||||
| Net (loss) income attributable to common stockholders - Mustang 3 | (3,599 | ) | (4,069 | ) | ||||
| Net (loss) income attributable to common stockholders - Caelum 4 | - | 18,384 | ||||||
| Non-GAAP net loss attributable to common stockholders a | $ | (7,731 | ) | $ | (7,830 | ) | ||
| Stock based compensation | 1,740 | 1,328 | ||||||
| Non-cash interest | 769 | 736 | ||||||
| Amortization of licenses | 355 | 234 | ||||||
| Amortization of debt discount | 488 | 622 | ||||||
| Depreciation | 154 | 193 | ||||||
| Fortress non-GAAP loss attributable to common stockholders b | $ | (4,224 | ) | $ | (4,717 | ) | ||
| Net (loss) income per common share attributable to common stockholders - basic and diluted 5 | $ | (0.19 | ) | $ | 0.03 | |||
| Non-GAAP net loss attributable to common stockholders a | $ | (0.12 | ) | $ | (0.12 | ) | ||
| Fortress non-GAAP loss per common share attributable to common stockholders - basic and diluted b | $ | (0.07 | ) | $ | (0.07 | ) | ||
| Weighted average common shares outstanding - basic and diluted 5 | 63,496,256 | 63,811,136 |
to non-GAAP research and development and general and administrative costs:
| For the three months ended March 31, | ||||||||
| ($ in thousands) | 2020 | 2019 | ||||||
| Research and development | $ | 14,867 | $ | 23,273 | ||||
| Less: | ||||||||
| Research and development Avenue | 697 | 10,241 | ||||||
| Research and development Checkpoint | 2,635 | 4,581 | ||||||
| Research and development Mustang 1 | 9,252 | 6,898 | ||||||
| Non-GAAP research and development costs | $ | 2,283 | $ | 1,553 | ||||
| General and admininstrative | $ | 15,519 | $ | 13,478 | ||||
| Less: | ||||||||
| General and administrative Avenue | 577 | 1,119 | ||||||
| General and administrative Checkpoint 2 | 1,553 | 1,569 | ||||||
| General and administrative Mustang 3 | 1,768 | 2,281 | ||||||
| Non-GAAP general and administrative costs | $ | 11,621 | $ | 8,509 |
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 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., 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.
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:
BIOTECH, INC. AND SUBSIDIARIES
except for share and per share amounts)
| March 31, | December 31, | |||||||
| 2020 | 2019 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 135,943 | $ | 136,858 | ||||
| Accounts receivable (net of allowance for doubtful accounts of $0 and $100 at March 31, 2020 and December 31, 2019, respectively) | 15,810 | 13,539 | ||||||
| Inventory | 769 | 857 | ||||||
| Other receivables - related party | 1,753 | 865 | ||||||
| Prepaid expenses and other current assets | 4,526 | 4,133 | ||||||
| Total current assets | 158,801 | 156,252 | ||||||
| Property and equipment, net | 12,785 | 12,433 | ||||||
| Operating lease right-of-use asset, net | 21,076 | 21,480 | ||||||
| Restricted cash | 16,574 | 16,574 | ||||||
| Long-term investment, at fair value | 11,148 | 11,148 | ||||||
| Intangible asset, net | 7,022 | 7,377 | ||||||
| Other assets | 1,353 | 1,158 | ||||||
| Total assets | $ | 228,759 | $ | 226,422 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable and accrued expenses | $ | 34,200 | $ | 35,451 | ||||
| Accounts payable and accrued expenses - related party | 13 | - | ||||||
| Interest payable | 1,081 | 1,042 | ||||||
| Interest payable - related party | 53 | 92 | ||||||
| Notes payable, short-term (net of debt discount of $0 at March 31, 2020 and December 31, 2019) | 14,522 | 7,220 | ||||||
| Operating lease liabilities - short-term | 1,794 | 1,784 | ||||||
| Derivative warrant liability | 69 | 27 | ||||||
| Total current liabilities | 51,732 | 45,616 | ||||||
| Notes payable, long-term (net of debt discount of $4,354 and $5,086 at March 31, 2020 and December 31, 2019, respectively) | 70,866 | 77,436 | ||||||
| Operating lease liabilities - long-term | 23,647 | 23,712 | ||||||
| Other long-term liabilities | 7,229 | 7,126 | ||||||
| Total liabilities | 153,474 | 153,890 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity | ||||||||
| Preferred stock, $.001 par value, 15,000,000 authorized, 5,000,000 designated Series A shares, 2,059,917 and 1,341,167 shares issued as of March 31, 2020 and December 31, 2019, respectively; 2,054,917 and 1,341,167 shares outstanding as of March 31, 2020 and December 31, 2019, respectively; liquidation value of $25.00 per share | 2 | 1 | ||||||
| Common stock, $.001 par value, 100,000,000 shares authorized, 78,572,169 and 74,027,425 shares issued and outstanding as of March 31, 2020 and December 31, 2019, respectively | 79 | 74 | ||||||
| Common stock issuable, 489,095 and 251,337 shares as of March 31, 2020 and December 31, 2019, respectively | 661 | 500 | ||||||
| Treasury stock | (70 | ) | - | |||||
| Additional paid-in-capital | 485,160 | 461,874 | ||||||
| Accumulated deficit | (448,604 | ) | (436,234 | ) | ||||
| Total stockholders' equity attributed to the Company | 37,228 | 26,215 | ||||||
| Non-controlling interests | 38,057 | 46,317 | ||||||
| Total stockholders' equity | 75,285 | 72,532 | ||||||
| Total liabilities and stockholders' equity | $ | 228,759 | $ | 226,422 |