Full Press Release Details
Fortress Biotech Reports 2023 Financial Results
and Recent Corporate Highlights
Record consolidated net revenue of $84.5
million for full-year 2023
Fortress may receive up to four regulatory
decisions on NDAs and BLAs in the next 18 months
FDA accepted New Drug Application filing
for DFD-29 to treat inflammatory lesions and erythema of
rosacea in adults; PDUFA goal date of November 4, 2024
March 28, 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 full-year ended December 31,
Lindsay A. Rosenwald, M.D., Fortress' Chairman,
President and Chief Executive Officer, said, "In 2023, we built a significant amount of momentum to position our Company to achieve
multiple milestones in 2024. We also generated record consolidated net revenues of $84.5 million in 2023, the majority of which came from
the sales and milestone payments from our dermatology and rare disease businesses."
continued, "We are pleased that the U.S. Food and Drug Administration ("FDA") accepted the New Drug Application ("NDA")
filing for DFD-29 earlier this month and look forward to the Prescription Drug User Fee Act ("PDUFA") goal date of
November 4, 2024. Across our portfolio, we could receive up to four NDA and Biologics License Application ("BLA") regulatory
approvals over the next 18 months, while we continue to advance our 25 development stage programs in 2024."
2023 and Recent Corporate Highlights1:
Regulatory Milestones and Updates
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 25 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. Such product candidates span six large-market
areas, including oncology, rare diseases and gene therapy, which allow it to create value for shareholders. Fortress advances its diversified
pipeline through a streamlined operating structure that fosters efficient drug development. The Fortress model is focused on leveraging
its significant biopharmaceutical industry expertise and network 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 AstraZeneca, City of Hope, Fred Hutchinson Cancer Center, St. Jude Children's
Research Hospital, Nationwide Children's Hospital and Sentynl. For more information, visit www.fortressbiotech.com.
Forward-Looking Statements
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; 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
Fortress Biotech, Inc.
Media Relations Contact:
FORTRESS BIOTECH, INC.
Consolidated Balance
($ in thousands except for
share and per share amounts)
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 80,927 | $ | 178,266 | ||||
| Accounts receivable, net | 15,222 | 28,208 | ||||||
| Inventory | 10,206 | 14,159 | ||||||
| Other receivables - related party | 167 | 138 | ||||||
| Prepaid expenses and other current assets | 10,500 | 9,661 | ||||||
| Total current assets | 117,022 | 230,432 | ||||||
| Property, plant and equipment, net | 6,505 | 13,020 | ||||||
| Operating lease right-of-use asset, net | 16,990 | 19,991 | ||||||
| Restricted cash | 2,438 | 2,688 | ||||||
| Intangible asset, net | 20,287 | 27,197 | ||||||
| Other assets | 4,284 | 973 | ||||||
| Total assets | $ | 167,526 | $ | 294,301 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
| Current liabilities | ||||||||
| Accounts payable and accrued expenses | $ | 73,562 | $ | 97,446 | ||||
| Income taxes payable | 843 | 722 | ||||||
| Common stock warrant liabilities | 886 | 13,869 | ||||||
| Operating lease liabilities, short-term | 2,523 | 2,447 | ||||||
| Partner company convertible preferred shares, short-term, net | 3,931 | 2,052 | ||||||
| Partner company line of credit | - | 2,948 | ||||||
| Partner company installment payments - licenses, short-term, net | 3,000 | 7,235 | ||||||
| Other short-term liabilities | 163 | 996 | ||||||
| Total current liabilities | 84,908 | 127,715 | ||||||
| Notes payable, long-term, net | 60,856 | 91,730 | ||||||
| Operating lease liabilities, long-term | 18,282 | 21,572 | ||||||
| Partner company installment payments - licenses, long-term, net | - | 1,412 | ||||||
| Other long-term liabilities | 1,893 | 1,847 | ||||||
| Total liabilities | 165,939 | 244,276 | ||||||
| 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 December 31, 2023 and December 31, 2022, respectively, liquidation value of $25.00 per share | 3 | 3 | ||||||
| Common stock, $0.001 par value, 200,000,000 shares authorized, 15,093,053 and 7,366,283 shares issued and outstanding as of December 31, 2023 and December 31, 2022, respectively | 15 | 7 | ||||||
| Additional paid-in-capital | 717,396 | 675,944 | ||||||
| Accumulated deficit | (694,870 | ) | (634,233 | ) | ||||
| Total stockholders' equity attributed to the Company | 22,544 | 41,721 | ||||||
| Non-controlling interests | (20,957 | ) | 8,304 | |||||
| Total stockholders' equity (deficit) | 1,587 | 50,025 | ||||||
| Total liabilities and stockholders' equity (deficit) | $ | 167,526 | $ | 294,301 |
FORTRESS BIOTECH, INC.
Consolidated Statements of Operations
($ in thousands except for share and per share
| Year Ended December 31, | ||||||||
| 2023 | 2022 | |||||||
| Revenue | ||||||||
| Product revenue, net | $ | 59,662 | $ | 70,995 | ||||
| Collaboration revenue | 5,229 | 1,882 | ||||||
| Revenue - related party | 103 | 192 | ||||||
| Other revenue | 19,519 | 2,674 | ||||||
| Net revenue | 84,513 | 75,743 | ||||||
| Operating expenses | ||||||||
| Cost of goods sold - product revenue | 26,660 | 30,775 | ||||||
| Research and development | 101,747 | 134,199 | ||||||
| Research and development - licenses acquired | 4,324 | 677 | ||||||
| Selling, general and administrative | 94,124 | 113,656 | ||||||
| Total operating expenses | 226,855 | 279,307 | ||||||
| Loss from operations | (142,342 | ) | (203,564 | ) | ||||
| Other income (expense) | ||||||||
| Interest income | 3,003 | 1,398 | ||||||
| Interest expense and financing fee | (15,315 | ) | (13,642 | ) | ||||
| Change in fair value of warrant liabilities | 4,424 | 1,129 | ||||||
| Other income (expense) | (3,403 | ) | 1,215 | |||||
| Total other income (expense) | (11,291 | ) | (9,900 | ) | ||||
| Loss before income tax expense | (153,633 | ) | (213,464 | ) | ||||
| Income tax expense | 521 | 449 | ||||||
| Net loss | (154,154 | ) | (213,913 | ) | ||||
| Net loss attributable to non-controlling interests | 93,517 | 127,338 | ||||||
| Net loss attributable to Fortress | (60,637 | ) | $ | (86,575 | ) | |||
| Preferred A dividends declared and paid | (8,032 | ) | (8,032 | ) | ||||
| Net loss attributable to common stockholders | $ | (68,669 | ) | (94,607 | ) | |||
| Net loss per common share attributable to common stockholders - basic and diluted | $ | (8.47 | ) | $ | (15.97 | ) | ||
| Weighted average common shares outstanding - basic and diluted | 8,110,906 | 5,924,967 |