Total net revenue increased 20.5% to $17.6 million for third quarter of 2025 compared to the third quarter of 2024
Fortress subsidiary Checkpoint Therapeutics acquired by Sun Pharma; Fortress received ~$28 million at closing and is eligible to receive up to an additional $4.8 million under a contingent value right (CVR), plus a 2.5% royalty on future net sales of UNLOXCYT™ (cosibelimab-ipdl)
Dotinurad, a next-generation URAT1 inhibitor, is advancing in two Phase 3 clinical trials with potential for best-in-class safety and efficacy following Crystalys Therapeutics' $205 million Series A financing
MIAMI, Nov. 14, 2025 (GLOBE NEWSWIRE) -- 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 income, today announced financial results and recent corporate highlights for the third quarter ended September 30, 2025.
Lindsay A. Rosenwald, M.D., Fortress' Chairman, President and Chief Executive Officer, said, "Fortress has achieved several strategic milestones that reinforce the strength of our diversified business model and our continued ability to enhance shareholder value across our portfolio. The acquisition of two subsidiaries this year, Checkpoint Therapeutics, Inc. ("Checkpoint"), by Sun Pharma and Baergic Bio, Inc. ("Baergic") by Axsome Therapeutics ("Axsome"), are both strategic exits that represent validation of our approach. The sale of Checkpoint generated approximately $28 million in upfront consideration, with the potential for additional contingent value right (CVR) payments and future royalty income from sales of UNLOXCYT™ (cosibelimab-ipdl) to Fortress. We also anticipate the resubmission of the New Drug Application ("NDA") for CUTX-101, which, upon approval, may qualify for a Priority Review Voucher—further demonstrating the potential embedded value in our pipeline. Journey Medical Corporation ("Journey Medical") continues to deliver strong operational execution, highlighted by the successful launch of Emrosi™ and accelerating commercial performance, supported by expanded payer coverage and new pooled Phase 3 data analysis presented at Fall Clinical demonstrating Emrosi's statistical and clinical superiority over Oracea® and placebo for the treatment of rosacea. Additionally, our late-stage pipeline continues to progress meaningfully, with dotinurad advancing in two Phase 3 trials for the treatment of gout. The $205 million Series A financing announced by Crystalys Therapeutics, Inc. ("Crystalys") underscores the market's confidence in dotinurad's best-in-class potential for safety and efficacy. Urica Therapeutics' ("Urica") strategic sale of dotinurad to Crystalys last year, in exchange for equity and a 3% royalty on future net sales, further positions Fortress to participate in long-term value creation. As we move forward, Fortress remains focused on disciplined execution, optimizing our capital allocation, and advancing high-impact assets that drive sustainable growth and deliver innovative treatments to patients worldwide."
Recent Corporate Highlights1:
Monetization Updates
Clinical Updates
Regulatory Updates
Commercial Product Updates
General Corporate:
Financial Results:
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 income. The company has eight marketed prescription pharmaceutical products and multiple 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, Nationwide Children's Hospital, Columbia University, Dana Farber Cancer Center and Sentynl Therapeutics. 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; uncertainty related to the timing and amounts expected to be realized from future milestone, contingent value right, royalty or similar future revenue streams, if at all; 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.
Company Contact:
Jaclyn Jaffe
Fortress Biotech, Inc.
(781) 652-4500
ir@fortressbiotech.com
Media Relations Contact:
Tony Plohoros
6 Degrees
(908) 591-2839
tplohoros@6degreespr.com
________________________
1 The development programs depicted in this press release include product candidates in development at Fortress, at Fortress' private or public subsidiaries (referred to herein as "subsidiaries" or "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.
| FORTRESS BIOTECH, INC. AND SUBSIDIARIES Condensed Consolidated Balance Sheets ($ in thousands except for share and per share amounts) | ||||||||
| September 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| ASSETS | (Unaudited) | |||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 86,218 | $ | 57,263 | ||||
| Accounts receivable, net | 17,983 | 10,231 | ||||||
| Inventory | 11,818 | 14,431 | ||||||
| Other receivables - related party | 142 | 171 | ||||||
| Prepaid expenses and other current assets | 2,342 | 7,110 | ||||||
| Assets held for sale | — | 1,165 | ||||||
| Total current assets | 118,503 | 90,371 | ||||||
| Property, plant and equipment, net | 2,611 | 3,260 | ||||||
| Operating lease right-of-use asset, net | 12,321 | 13,861 | ||||||
| Restricted cash | 1,220 | 1,552 | ||||||
| Intangible assets, net | 28,670 | 31,863 | ||||||
| Other assets | 18,082 | 3,316 | ||||||
| Total assets | $ | 181,407 | $ | 144,223 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
| Current liabilities | ||||||||
| Accounts payable and accrued expenses | $ | 45,171 | $ | 65,501 | ||||
| Income taxes payable | 1,005 | 932 | ||||||
| Common stock warrant liabilities | 2 | 214 | ||||||
| Operating lease liabilities, short-term | 2,129 | 2,623 | ||||||
| Partner company notes payable, short-term | 5,625 | — | ||||||
| Partner company installment payments - licenses, short-term | — | 625 | ||||||
| Other current liabilities | 135 | 1,504 | ||||||
| Total current liabilities | 54,067 | 71,399 | ||||||
| Notes payable, long-term, net | 47,774 | 57,962 | ||||||
| Operating lease liabilities, long-term | 12,765 | 14,750 | ||||||
| Other long-term liabilities | 1,616 | 1,756 | ||||||
| Total liabilities | 116,222 | 145,867 | ||||||
| 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, 2025 and December 31, 2024, respectively, liquidation value of $25.00 per share | 3 | 3 | ||||||
| Common stock, $0.001 par value, 200,000,000 shares authorized, 31,005,170 and 27,908,839 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively | 31 | 28 | ||||||
| Additional paid-in-capital | 785,943 | 763,573 | ||||||
| Accumulated deficit | (730,115 | ) | (740,867 | ) | ||||
| Total stockholders' equity attributed to the Company | 55,862 | 22,737 | ||||||
| Non-controlling interests | 9,323 | (24,381 | ) | |||||
| Total stockholders' equity (deficit) | 65,185 | (1,644 | ) | |||||
| Total liabilities and stockholders' equity (deficit) | $ | 181,407 | $ | 144,223 | ||||
| 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, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenue | ||||||||||||||||
| Product revenue, net | $ | 17,025 | $ | 14,629 | $ | 45,173 | $ | 42,514 | ||||||||
| Revenue - related party | — | — | — | 41 | ||||||||||||
| Other revenue | 606 | — | 2,010 | — | ||||||||||||
| Net revenue | 17,631 | 14,629 | 47,183 | 42,555 | ||||||||||||
| Operating expenses | ||||||||||||||||
| Cost of goods - (excluding amortization of acquired intangible assets) | 5,755 | 4,471 | 15,484 | 16,199 | ||||||||||||
| Amortization of acquired intangible assets | 1,064 | 814 | 3,193 | 2,443 | ||||||||||||
| Research and development | 208 | 9,446 | 12,268 | 46,941 | ||||||||||||
| Selling, general and administrative | 17,415 | 21,993 | 81,670 | 60,867 | ||||||||||||
| Asset impairment | — | — | — | 2,649 | ||||||||||||
| Total operating expenses | 24,442 | 36,724 | 112,615 | 129,099 | ||||||||||||
| Loss from operations | (6,811 | ) | (22,095 | ) | (65,432 | ) | (86,544 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Interest income | 736 | 589 | 1,848 | 2,157 | ||||||||||||
| Interest expense and financing fee | (2,742 | ) | (6,209 | ) | (8,065 | ) | (10,933 | ) | ||||||||
| Gain (loss) on common stock warrant liabilities | (2 | ) | 19 | (399 | ) | (578 | ) | |||||||||
| Gain from deconsolidation of subsidiary | — | — | 27,127 | — | ||||||||||||
| Other income | 17,672 | 1,071 | 17,599 | 1,334 | ||||||||||||
| Total other income (expense) | 15,664 | (4,530 | ) | 38,110 | (8,020 | ) | ||||||||||
| Income (loss) before income tax expense | 8,853 | (26,625 | ) | (27,322 | ) | (94,564 | ) | |||||||||
| Income tax expense (refund) | 26 | 69 | 196 | (24 | ) | |||||||||||
| Net income (loss) | 8,827 | (26,694 | ) | (27,518 | ) | (94,540 | ) | |||||||||
| Attributable to non-controlling interests | (2,977 | ) | 13,827 | 38,270 | 55,308 | |||||||||||
| Net income (loss) attributable to Fortress | $ | 5,850 | $ | (12,867 | ) | $ | 10,752 | $ | (39,232 | ) | ||||||
| Preferred A dividends declared and paid and/or cumulated, and Fortress' share of subsidiary deemed dividends | (2,174 | ) | (2,173 | ) | (6,436 | ) | (7,006 | ) | ||||||||
| Net income (loss) attributable to common stockholders | $ | 3,675 | $ | (15,040 | ) | $ | 4,316 | $ | (46,238 | ) | ||||||
| Net income (loss) per common share attributable to common stockholders - basic | $ | 0.13 | $ | (0.76 | ) | $ | 0.16 | $ | (2.43 | ) | ||||||
| Net income (loss) per common share attributable to common stockholders - diluted | $ | 0.11 | $ | (0.76 | ) | $ | 0.14 | $ | (2.43 | ) | ||||||
| Weighted average common shares outstanding - basic | 27,244,474 | 19,697,290 | 27,075,216 | 19,041,590 | ||||||||||||
| Weighted average common shares outstanding - diluted | 33,100,961 | 19,697,290 | 30,695,996 | 19,041,590 | ||||||||||||
