Globe Newswire 9-Nov-2018 7:30 AM
NEW YORK, Nov. 09, 2018 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ:FBIO) ("Fortress"), a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products, today announced financial results and recent corporate highlights for the third quarter ended September 30, 2018.
Lindsay A. Rosenwald, M.D., Fortress' Chairman, President and Chief Executive Officer, said, "Fortress and our subsidiaries continued to achieve important corporate and clinical milestones in the third quarter of 2018. Mustang Bio expanded its pipeline into gene therapy by securing an exclusive worldwide license for the development of a potentially first-in-class ex vivo lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency ("X-SCID") from St. Jude Children's Research Hospital ("St. Jude"). Additionally, Checkpoint Therapeutics announced positive interim safety and efficacy data from its Phase 1/2 clinical trial of CK-101, a third-generation epidermal growth factor receptor ("EGFR") inhibitor being evaluated in advanced non-small cell lung cancer ("NSCLC"). Finally, Cyprium Therapeutics' product candidate for patients diagnosed with classic Menkes disease, CUTX-101, was granted Fast Track Designation by the U.S. Food and Drug Administration ("FDA"). We plan to continue to acquire and develop compelling and, in some instances, potentially life-saving product candidates, which could lead to maximizing long-term shareholder value."
Recent Fortress and Fortress Company Highlights:
Aevitas Therapeutics, Inc.
Caelum Biosciences, Inc.
Checkpoint Therapeutics, Inc.
Cyprium Therapeutics, Inc.
Mustang Bio, Inc.
About Fortress Biotech
Fortress is a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products. Fortress develops and commercializes products both within Fortress and through certain subsidiary companies, also known as Fortress Companies. In addition to its internal development programs, Fortress leverages its biopharmaceutical business expertise and drug development capabilities and provides funding and management services to help the Fortress Companies achieve their goals. Fortress and the Fortress Companies may seek licensing arrangements, acquisitions, partnerships, joint ventures and/or public and private financings to accelerate and provide additional funding to support their research and development programs. For more information, visit www.fortressbiotech.com.
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. 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.
Fortress Biotech, Inc.
Investor Relations Contact:
Managing Director, LifeSci Advisors, LLC
Media Relations Contact:
1 Fortress acquired approximately 56 percent of National Holdings in September 2016.
FORTRESS BIOTECH, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
($ in thousands except for share and per share amounts)
|Cash and cash equivalents||$||95,867||$||113,915|
|Short-term investments (certificates of deposit)||22,538||36,002|
|Cash deposits with clearing organizations||336||1,041|
|Receivables from broker-dealers and clearing organizations||11,884||7,395|
|Forgivable loans receivable||1,610||1,616|
|Securities owned, at fair value||6,675||1,985|
|Other receivables - related party||414||618|
|Prepaid expenses and other current assets||14,089||12,680|
|Total current assets||159,518||183,181|
|Property and equipment, net||14,642||9,513|
|Long-term investments, at fair value||–||1,390|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable and accrued expenses||$||37,345||$||36,127|
|Accounts payable and accrued expenses - related party||153||222|
|Accrued commissions and payroll payable||11,974||10,065|
|Deferred clearing and marketing credits||629||786|
|Securities sold, not yet purchased, at fair value||24||151|
|Warrants issued - National||–||5,597|
|Interest payable - related party||94||97|
|Notes payable, short-term (net of debt discount of $447 and $973 at September 30, 2018 and December 31, 2017, respectively)||9,054||8,528|
|Subsidiary convertible note, short-term, at fair value||10,657||4,700|
|Derivative warrant liability||–||87|
|Other current liabilities||77||181|
|Total current liabilities||70,775||67,428|
|Notes payable, long-term (net of debt discount of $445 and $62 at September 30, 2018 and December 31, 2017, respectively)||64,546||43,222|
|Subsidiary convertible note, long-term, at fair value||–||10,059|
|Other long-term liabilities||4,961||4,739|
|Preferred stock, $0.001 par value, 15,000,000 authorized, 5,000,000 designated Series A shares, 1,000,000 shares issued and outstanding as of September 30, 2018 and December 31, 2017, respectively; liquidation value of $25.00 per share||1||1|
|Common stock, $0.001 par value, 100,000,000 shares authorized, 56,183,480 and 50,991,285 shares issued and outstanding as of September 30, 2018 and December 31, 2017, respectively||56||51|
|Common stock issuable, 347,684 and 158,015 shares as of September 30, 2018 and December 31, 2017, respectively||495||500|
|Total stockholders' equity attributed to the Company||37,773||52,573|
|Total stockholders' equity||84,637||120,502|
|Total liabilities and stockholders' equity||$||224,919||$||245,950|
FORTRESS BIOTECH, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
($ in thousands except for share and per share amounts)
|For the Three Months Ended
|For the Nine Months Ended
|Product revenue, net||$||5,168||$||2,170||$||17,366||$||8,309|
|Revenue - from a related party||5||350||525||1,393|
|Net Fortress revenue||5,173||2,520||17,891||9,702|
|Net dealer inventory gains||482||1,789||5,601||6,666|
|Interest and dividends||771||674||2,003||2,065|
|Transfer fees and clearing services||1,606||1,649||5,680||5,834|
|Tax preparation and accounting||2,444||2,527||6,835||6,527|
|Total National revenue||58,520||44,366||165,061||132,563|
|Cost of goods sold - product revenue||1,406||505||4,546||1,852|
|Research and development||16,082||15,890||58,528||34,683|
|Research and development - licenses acquired||3,706||300||3,804||3,394|
|General and administrative||12,184||15,104||38,788||36,490|
|Total Fortress operating expenses||33,378||31,799||105,666||76,419|
|Commissions, compensation and fees||48,556||39,963||141,462||118,983|
|Licenses and registration||861||391||2,028||1,223|
|Depreciation and amortization||871||507||2,587||1,513|
|Other administrative expenses||1,726||3,610||5,839||7,315|
|Total National operating expenses||55,204||47,690||162,258||139,219|
|Total operating expenses||88,582||79,489||267,924||215,638|
|Loss from operations||(24,889||)||(32,603||)||(84,972||)||(73,373||)|
|Other income (expenses)|
|Interest expense and financing fee||(2,228||)||(3,220||)||(6,455||)||(5,298||)|
|Change in fair value of derivative liabilities||-||(639||)||(7,931||)||5,155|
|Change in fair value of subsidiary convertible note||(84||)||(74||)||26||(359||)|
|Change in fair value of investments||(565||)||270||(1,390||)||(241||)|
|Total other expenses||(2,754||)||(3,704||)||(15,167||)||(445||)|
|Loss before income taxes||(27,643||)||(36,307||)||(100,139||)||(73,818||)|
|Income tax expense||944||–||2,382||–|
|Less: net loss attributable to non-controlling interests||(11,949||)||(9,191||)||(43,254||)||(17,355||)|
|Net loss attributable to common stockholders||$||(16,638||)||$||(27,116||)||$||(59,267||)||$||(56,463||)|
|Basic and diluted net loss per common share||$||(0.37||)||$||(0.67||)||$||(1.36||)||$||(1.39||)|
|Weighted average common shares outstanding-basic and diluted||44,818,186||40,724,115||43,578,763||40,547,364|
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