Full Press Release Details
Fortress Biotech Reports Third Quarter 2024 Financial Results and Recent Corporate Highlights
Emrosi approved by FDA on November 4 for the treatment of inflammatory lesions of rosacea in adults
Cosibelimab PDUFA goal date of December 28 for potential approval to treat metastatic or locally advanced cutaneous squamous cell carcinoma
Miami, FL - November 14, 2024 - Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, today announced financial results and recent corporate highlights for the third quarter ended September 30, 2024.
Lindsay A. Rosenwald, M.D., Fortress' Chairman, President and Chief Executive Officer, said, "We are thrilled to have received U.S. Food and Drug Administration ("FDA") approval for Emrosi , a potential best-in-class treatment for inflammatory lesions of rosacea in adults, which is a tremendous milestone for Fortress and our partner company, Journey Medical Corporation ("Journey Medical"). This marks the first FDA approval across the Fortress portfolio, and demonstrates our ability to successfully in-license a clinical stage program and develop it through commercialization. We could achieve up to two more U.S. FDA approvals in the next nine months, and our next anticipated PDUFA goal date is December 28, 2024, for cosibelimab, an anti-PD-L1 antibody, for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC"). We have an exciting late-stage pipeline with many upcoming value creation opportunities, and we are focused on attaining our long-term strategy of building shareholder value, while bringing innovative treatment options to patients with unmet medical needs."
Recent Corporate Highlights1:
1 The development programs depicted in this press release include product candidates in development at Fortress, at Fortress' private subsidiaries (referred to herein as "subsidiaries"), at Fortress' public subsidiaries (referred to herein as "partner companies") and at entities with whom one of the foregoing parties has a significant business relationship, such as an exclusive license or an ongoing product-related payment obligation (such entities referred to herein as "partners"). The words "we", "us" and "our" may refer to Fortress individually, to one or more of our subsidiaries and/or partner companies, or to all such entities as a group, as dictated by context.
Commercial Product Updates
About Fortress Biotech
Fortress Biotech, Inc. ("Fortress") is an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue. The company has seven marketed prescription pharmaceutical products and over 20 programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Fortress' portfolio is being commercialized and developed for various therapeutic areas including oncology, dermatology, and rare diseases. Fortress' model is focused on leveraging its significant biopharmaceutical industry expertise and network to further expand and advance 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 AstraZeneca, City of Hope, Fred Hutchinson Cancer Center, Nationwide Children's Hospital and Sentynl. For more information, visit www.fortressbiotech.com.
Forward-Looking Statements
Statements in this press release that are not descriptions of historical facts are "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. The words "anticipates," "believes," "can," "continue," "could," "estimates," "expects," "intends," "may," "might," "plans," "potential," "predicts," "should," or "will" or the negative of these terms or other comparable terminology are generally intended to identify forward-looking statements. These
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, financing and strategic agreements and relationships; our need for substantial additional funds and uncertainties relating to financings; our ability to identify, acquire, close and integrate product candidates successfully and on a timely basis; our ability to attract, integrate and retain key personnel; the early stage of products under development; the results of research and development activities; uncertainties relating to preclinical and clinical testing; our ability to obtain regulatory approval for products under development; our ability to successfully commercialize products for which we receive regulatory approval or receive royalties or other distributions from third parties; our ability to secure and maintain third-party manufacturing, marketing and distribution of our and our partner companies' products and product candidates; 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, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. 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.
Fortress Biotech, Inc.
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FORTRESS BIOTECH, INC. AND SUBSIDIARIES
Unaudited Condensed Consolidated Balance Sheets
($ in thousands except for share and per share amounts)
| September 30, | December 31, | |||||
| 2024 | 2023 | |||||
| ASSETS | ||||||
| Current assets | ||||||
| Cash and cash equivalents | $ | 58,853 | $ | 80,927 | ||
| Accounts receivable, net | 10,671 | 15,222 | ||||
| Inventory | 11,788 | 10,206 | ||||
| Other receivables - related party | 174 | 167 | ||||
| Prepaid expenses and other current assets | 2,583 | 10,500 | ||||
| Assets held for sale | 2,209 | - | ||||
| Total current assets | 86,278 | 117,022 | ||||
| Property, plant and equipment, net | 3,403 | 6,505 | ||||
| Operating lease right-of-use asset, net | 14,152 | 16,990 | ||||
| Restricted cash | 2,063 | 2,438 | ||||
| Intangible assets, net | 17,844 | 20,287 | ||||
| Other assets | 3,345 | 4,284 | ||||
| Total assets | $ | 127,085 | $ | 167,526 | ||
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||
| Current liabilities | ||||||
| Accounts payable and accrued expenses | $ | 64,499 | $ | 73,562 | ||
| Income taxes payable | 850 | 843 | ||||
| Common stock warrant liabilities | 154 | 886 | ||||
| Operating lease liabilities, short-term | 2,514 | 2,523 | ||||
| Partner company convertible preferred shares, short-term, net | - | 3,931 | ||||
| Partner company installment payments - licenses, short-term | 1,250 | 3,000 | ||||
| Other short-term liabilities | 1,038 | 163 | ||||
| Total current liabilities | 70,305 | 84,908 | ||||
| Notes payable, long-term, net | 52,473 | 60,856 | ||||
| Operating lease liabilities, long-term | 15,292 | 18,282 | ||||
| Other long-term liabilities | 1,753 | 1,893 | ||||
| Total liabilities | 139,823 | 165,939 | ||||
| Commitments and contingencies | ||||||
| Stockholders' equity (deficit) | ||||||
| Cumulative redeemable perpetual preferred stock, $0.001 par value, 15,000,000 authorized, 5,000,000 designated Series A shares, 3,427,138 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively, liquidation value of $25.00 per share | 3 | 3 | ||||
| Common stock, $0.001 par value, 200,000,000 shares authorized, 27,584,600 and 15,093,053 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively | 28 | 15 | ||||
| Additional paid-in-capital | 755,229 | 717,396 | ||||
| Accumulated deficit | (734,102) | (694,870) | ||||
| Total stockholders' equity attributed to the Company | 21,158 | 22,544 | ||||
| Non-controlling interests | (33,896) | (20,957) | ||||
| Total stockholders' equity (deficit) | (12,738) | 1,587 | ||||
| Total liabilities and stockholders' equity (deficit) | $ | 127,085 | $ | 167,526 |
FORTRESS BIOTECH, INC. AND SUBSIDIARIES
Unaudited Condensed Consolidated Statements of Operations
($ in thousands except for share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||
| Revenue | |||||||||||||
| Product revenue, net | $ | 14,629 | $ | 15,279 | $ | 42,514 | $ | 44,405 | |||||
| Collaboration revenue | - | 182 | - | 546 | |||||||||
| Revenue - related party | - | 31 | 41 | 97 | |||||||||
| Other revenue | - | 19,260 | - | 19,519 | |||||||||
| Net revenue | 14,629 | 34,752 | 42,555 | 64,567 | |||||||||
| Operating expenses | |||||||||||||
| Cost of goods sold - product revenue | 5,285 | 6,429 | 18,642 | 20,645 | |||||||||
| Research and development | 9,446 | 20,288 | 46,941 | 87,702 | |||||||||
| Research and development - licenses acquired | - | 60 | - | 4,293 | |||||||||
| Selling, general and administrative | 21,993 | 21,733 | 60,867 | 71,512 | |||||||||
| Asset impairment | - | - | 2,649 | 3,143 | |||||||||
| Total operating expenses | 36,724 | 48,510 | 129,099 | 187,295 | |||||||||
| Loss from operations | (22,095) | (13,758) | (86,544) | (122,728) | |||||||||
| Other income (expense) | |||||||||||||
| Interest income | 589 | 547 | 2,157 | 2,296 | |||||||||
| Interest expense and financing fee | (6,209) | (2,534) | (10,933) | (13,255) | |||||||||
| Gain (loss) on common stock warrant liabilities | 19 | 4,542 | (578) | 10,708 | |||||||||
| Other income (expense) | 1,071 | 620 | 1,334 | (2,049) | |||||||||
| Total other income (expense) | (4,530) | 3,175 | (8,020) | (2,300) | |||||||||
| Loss before income tax expense | (26,625) | (10,583) | (94,564) | (125,028) | |||||||||
| Income tax expense (refund) | 69 | 141 | (24) | 142 | |||||||||
| Net loss | (26,694) | (10,724) | (94,540) | (125,170) | |||||||||
| Net loss attributable to non-controlling interests | 13,827 | 5,679 | 55,308 | 73,812 | |||||||||
| Net loss attributable to Fortress | $ | (12,867) | $ | (5,045) | $ | (39,232) | $ | (51,358) | |||||
| Preferred A dividends declared and paid and/or cumulated, and Fortress' share of subsidiary deemed dividends | (2,173) | (2,008) | (7,006) | (6,024) | |||||||||
| Net loss attributable to common stockholders | $ | (15,040) | $ | (7,053) | $ | (46,238) | $ | (57,382) | |||||
| Net loss per common share attributable to common stockholders - basic and diluted | $ | (0.76) | $ | (0.94) | $ | (2.43) | $ | (7.94) | |||||
| Weighted average common shares outstanding - basic and diluted | 19,697,290 | 7,498,653 | 19,041,590 | 7,231,004 |