Questions? +1 (202) 335-3939 Login
Trusted News Since 1995
A service for healthcare industry professionals · Saturday, September 21, 2019 · 497,024,995 Articles · 3+ Million Readers

Fortress Biotech Reports Second Quarter 2019 Financial Results and Recent Corporate Highlights

/EIN News/ -- NEW YORK, Aug. 09, 2019 (GLOBE NEWSWIRE) -- 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 second quarter ended June 30, 2019.

Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “We are pleased to have achieved several important milestones in the second quarter, including positive data for three of our late-stage product candidates in development across our partner companies: IV tramadol for post-surgical pain management; MB-107 gene therapy for the treatment of X-linked severe combined immunodeficiency (XSCID); and cosibelimab, an anti-programmed death ligand-1 (PD-L1) antibody for the treatment of multiple advanced cancers. Looking ahead to the remainder of 2019, we anticipate multiple potentially value-creating catalysts, including a New Drug Application filing for IV tramadol and additional important clinical data readouts for many of our product candidates. Our world-class business development team continues to focus on expanding our diverse pipeline with additional high-quality biotech and specialty pharmaceutical assets, further de-risking our product portfolio.”

Financial Results:

  • As of June 30, 2019, Fortress’ consolidated cash, cash equivalents, short-term investments (certificates of deposit), and restricted cash totaled $170.5 million, compared to $137.5 million as of March 31, 2019, and $99.2 million as of December 31, 2018, an increase of $33.0 million for the quarter and an increase of $71.3 million year-to-date.
  • Fortress’ net revenue totaled $9.3 million for the second quarter of 2019, compared to $6.8 million for the second quarter of 2018.
  • Research and development expenses were $18.5 million for the second quarter of 2019, of which $18.0 million was related to Fortress partner companies. This compares to $17.5 million for the second quarter of 2018, of which $15.1 million was related to Fortress partner companies. Non-cash, stock-based compensation expenses included in research and development were $0.8 million for both the second quarter of 2019 and 2018.
  • Research and development expenses from license acquisitions totaled $0.2 million for the second quarter of 2019, compared to a nominal amount for the second quarter of 2018.
  • General and administrative expenses were $13.4 million for the second quarter of 2019, of which $9.3 million was related to Fortress partner companies. This compares to $13.1 million for the second quarter of 2018, of which $7.7 million was related to Fortress partner companies. Non-cash, stock-based compensation expenses included in general and administrative expenses were $2.6 million for the second quarter of 2019, compared to $2.4 million for the second quarter of 2018.
  • Net loss attributable to common stockholders was $13.1 million, or $0.24 per share, for the second quarter of 2019, compared to a net loss attributable to common stockholders of $21.6 million, or $0.50 per share, for the second quarter of 2018. For the first six months of 2019, net loss attributable to common stockholders was $11.7 million or $0.23 per share, compared to $42.6 million or $0.99 per share for the first six months of 2018.

Recent Corporate Highlights1:
             
Marketed Dermatology Products

  • In the second quarter of 2019, our marketed products generated net revenue of $8.2 million, compared to $6.7 million in the second quarter of 2018.
  • We are anticipating the launch of a second prescription oral antibiotic drug for acne during the current quarter, Q3 2019.
  • This new asset, coupled with our salesforce expansion to 34 territory managers, will allow us to reach over 5,000 dermatologists across the country. This combination is expected to fuel the growth of our dermatology portfolio in 2019 and beyond.
  • Our dermatology products are marketed by our partner company, Journey Medical Corporation.

IV Tramadol

  • In June 2019, we announced that our second pivotal Phase 3 trial of IV tramadol achieved the primary endpoint of a statistically significant improvement in Sum of Pain Intensity Difference over 24 hours (SPID24) compared to placebo in patients with postoperative pain following abdominoplasty surgery. In addition, the trial met all of its key secondary endpoints. The study also included a standard-of-care IV opioid as an active comparator, IV morphine 4 mg. In this study, IV tramadol also demonstrated similar efficacy and safety to that of IV morphine.
  • IV Tramadol is currently in development at our partner company, Avenue Therapeutics, Inc.

MB-102 (CD123 CAR T)

  • In July 2019, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to MB-102 (CD123 CAR T) for the treatment of acute myeloid leukemia (AML).
  • In August 2019, we announced that the FDA has approved the Investigational New Drug (IND) application to initiate a multicenter Phase 1/2 clinical trial of MB-102 (CD123 CAR T) in AML, blastic plasmacytoid dendritic cell neoplasm (BPDCN) and high-risk myelodysplastic syndrome (MDS).
  • MB-102 is currently in development at our partner company, Mustang Bio, Inc.

MB-108 (Oncolytic Virus C134)

  • In May 2019, the FDA granted Orphan Drug Designation to MB-108 (oncolytic virus C134) for the treatment of malignant glioma, a type of brain cancer with a median survival of less than 18 months.
  • MB-108 is currently in development at our partner company, Mustang Bio, Inc.

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 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.

Company Contacts:
Jaclyn Jaffe and William Begien
Fortress Biotech, Inc.
(781) 652-4500
ir@fortressbiotech.com

Investor Relations Contact:
Daniel Ferry
LifeSci Advisors, LLC
(617) 535-7746
daniel@lifesciadvisors.com

Media Relations Contact:
Tony Plohoros
6 Degrees
(908) 940-0135
tplohoros@6degreespr.com  


FORTRESS BIOTECH, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
 ($ in thousands except for share and per share amounts)

    June 30,     December 31,  
    2019     2018  
    (Unaudited)        
ASSETS                
Current assets                
Cash and cash equivalents   $ 149,407     $ 65,508  
Accounts receivable (net of allowance of $250 and $0 at June 30, 2019 and December 31, 2018, respectively)     3,104       5,498  
Short-term investments (certificates of deposit)     5,000       17,604  
Inventory     732       678  
Other receivables - related party     1,850       2,095  
Prepaid expenses and other current assets     3,418       6,735  
Current assets held for sale     -       13,089  
Total current assets     163,511       111,207  
                 
Property and equipment, net     12,023       12,019  
Operating lease right-of-use asset, net     22,255       -  
Restricted cash     16,074       16,074  
Long-term investment, at fair value     11,193       -  
Intangible asset     971       1,417  
Other assets     1,237       276  
Total assets   $ 227,264     $ 140,993  
                 
LIABILITIES AND STOCKHOLDERS' EQUITY                
Current liabilities                
Accounts payable and accrued expenses   $ 24,260     $ 34,067  
Accounts payable and accrued expenses - related party     -       149  
Interest payable     1,022       1,232  
Interest payable - related party     94       97  
Notes payable, short-term - related party (net of debt discount of $104 and $336 at June 30, 2019 and December 31, 2018, respectively)     9,396       9,164  
Partner company convertible note, short-term, at fair value     -       9,914  
Operating lease liabilities - short-term     1,626       -  
Derivative warrant liability     -       991  
Total current liabilities     36,398       55,614  
                 
Notes payable, long-term (net of debt discount of $6,435 and $4,567 at June 30, 2019 and December 31, 2018, respectively)     74,307       60,425  
Operating lease liabilities - long-term     24,510       -  
Other long-term liabilities     2,229       5,211  
Total liabilities     137,444       121,250  
                 
Commitments and contingencies                
                 
Stockholders' equity                
Preferred stock, $.001 par value, 15,000,000 authorized, 5,000,000 designated Series A shares, 1,000,000 shares issued and outstanding as of June 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, 68,138,203 and 57,845,447 shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively     68       58  
Common stock issuable, 317,804 and 744,322 shares as of June 30, 2019 and December 31, 2018, respectively     490       659  
Additional paid-in-capital     439,295       397,408  
Accumulated deficit     (407,980 )     (396,274 )
Total stockholders' equity attributed to the Company     31,874       1,852  
                 
Non-controlling interests     57,946       17,891  
Total stockholders' equity     89,820       19,743  
Total liabilities and stockholders' equity   $ 227,264     $ 140,993  



FORTRESS BIOTECH, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
 ($ in thousands except for share and per share amounts)
(Unaudited)

    Three Months Ended June 30,     Six Months Ended June 30,  
    2019     2018     2019     2018  
Revenue                                
Product revenue, net   $ 8,199     $ 6,689     $ 14,324     $ 12,198  
Revenue - from a related party     1,051       126       1,403       520  
Net revenue     9,250       6,815       15,727       12,718  
                                 
Operating expenses                                
Cost of goods sold - product revenue     2,386       1,668       4,270       3,140  
Research and development     18,511       17,488       41,784       42,446  
Research and development – licenses acquired     200       1       650       98  
General and administrative     13,443       13,056       26,921       26,604  
Total operating expenses     34,540       32,213       73,625       72,288  
Loss from operations     (25,290 )     (25,398 )     (57,898 )     (59,570 )
                                 
Other income (expenses)                                
Interest income     779       294       1,217       572  
Interest expense and financing fee     (3,106 )     (2,590 )     (5,575 )     (4,993 )
Change in fair value of derivative liability     -       79       -       102  
Change in fair value of subsidiary convertible note     -       (140 )     -       110  
Change in fair value of investments     -       (707 )     -       (825 )
Other loss     -       (333 )     -       (333 )
Gain on deconsolidation of Caelum     137       -       18,521       -  
Total other (expenses) income     (2,190 )     (3,397 )     14,163       (5,367 )
Loss from continuing operations     (27,480 )     (28,795 )     (43,735 )     (64,937 )
                                 
Discontinued operations:                                
Loss from discontinued operations, net of tax     -       (6,921 )     -       (8,997 )
Total loss from discontinued operations     -       (6,921 )     -       (8,997 )
Net loss     (27,480 )     (35,716 )     (43,735 )     (73,934 )
                                 
Less: net loss attributable to non-controlling interests     14,382       14,105       32,029       31,305  
Net loss attributable to common stockholders   $ (13,098 )   $ (21,611 )   $ (11,706 )   $ (42,629 )
                                 
Loss from continuing operations per common share - basic and diluted   $ (0.51 )   $ (0.66 )   $ (0.86 )   $ (1.51 )
Loss from discontinued operations per common share - basic and diluted   $ -     $ (0.16 )   $ -     $ (0.21 )
Net loss per common share attributable to common stockholders - basic and diluted   $ (0.24 )   $ (0.50 )   $ (0.23 )   $ (0.99 )
                                 
Weighted average common shares outstanding - basic and diluted     53,726,125       43,377,629       51,130,977       42,948,780  


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/or partners, as dictated by context.

Primary Logo

Powered by EIN News
Distribution channels: Business & Economy, Technology


EIN Presswire does not exercise editorial control over third-party content provided, uploaded, published, or distributed by users of EIN Presswire. We are a distributor, not a publisher, of 3rd party content. Such content may contain the views, opinions, statements, offers, and other material of the respective users, suppliers, participants, or authors.

Submit your press release