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FORTRESS BIOTECH, INC. ANNUAL REPORT ON FORM 10-K

Press release·03/31/2025 22:34:49
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FORTRESS BIOTECH, INC. ANNUAL REPORT ON FORM 10-K

FORTRESS BIOTECH, INC. ANNUAL REPORT ON FORM 10-K

Fortress Biotech, Inc. reported its financial results for the fiscal year ended December 31, 2024. The company’s total revenue was $23.1 million, a decrease of 14% compared to the prior year. Net loss was $43.1 million, or $1.45 per share, compared to a net loss of $34.1 million, or $1.14 per share, in the prior year. The company’s cash and cash equivalents decreased to $14.3 million as of December 31, 2024, compared to $24.1 million as of December 31, 2023. The company’s research and development expenses increased by 15% to $24.4 million, primarily due to increased spending on its pipeline programs. The company’s general and administrative expenses decreased by 12% to $13.4 million, primarily due to reduced personnel costs. The company’s balance sheet reflects a significant decrease in cash and cash equivalents, which may impact its ability to fund its operations and pursue its business objectives.

Fortress Biotech’s Diverse Portfolio and Strategic Moves

Fortress Biotech, a biopharmaceutical company focused on acquiring, developing and commercializing novel pharmaceutical and biotechnology products, has had an eventful year marked by both progress and challenges across its diverse portfolio.

Revenue and Profit Trends In 2024, Fortress reported total net revenue of $57.7 million, down 32% from $84.5 million in 2023. This decline was primarily driven by a $19 million upfront payment received in 2023 for the exclusive license of Qbrexza in Asia, which was not repeated in 2024. Fortress’ core product revenue from its subsidiary Journey Medical Corporation (JMC) decreased 8% to $55.1 million, due to higher managed care rebates and lower sales volumes for some legacy products facing generic competition.

On the positive side, Fortress saw the FDA approvals of two key late-stage assets - Emrosi for rosacea and UNLOXCYT for cutaneous squamous cell carcinoma. The approval of these products should provide a boost to future revenues. Fortress also made progress advancing its pipeline, with several ongoing late-stage trials for products like CUTX-101 for Menkes disease and CAEL-101 for AL amyloidosis.

Despite the revenue decline, Fortress was able to reduce its operating expenses by 26% to $168 million, primarily through lower R&D spending. This, combined with a 10% decrease in other expenses, led to a 22% reduction in Fortress’ net loss to $120.9 million. The company’s public subsidiaries also raised a combined $49.7 million through equity offerings and warrant exercises, providing additional capital.

Strengths and Weaknesses A key strength of Fortress is the breadth and diversity of its portfolio, with late-stage assets, commercial products, and an active pipeline of earlier-stage candidates. This diversification helps mitigate risk, as setbacks with any one program are less likely to significantly impact the overall business. The recent FDA approvals for Emrosi and UNLOXCYT demonstrate Fortress’ ability to successfully navigate the regulatory process and bring new therapies to market.

However, Fortress continues to struggle with profitability, reporting a net loss of $120.9 million in 2024. The company’s high R&D expenses, which accounted for 34% of total operating expenses, are a significant drag on its bottom line. While Fortress was able to reduce these costs in 2024, further optimization may be necessary to achieve sustained profitability.

Another weakness is Fortress’ reliance on external financing to fund its operations. The company raised $21.1 million through equity offerings in 2024, and it also secured a new $50 million term loan from Oaktree Capital. This ongoing need for capital infusions could limit Fortress’ flexibility and make it vulnerable to changes in the financing environment.

Outlook and Future Prospects Looking ahead, Fortress is positioned for potential growth with the recent approvals of Emrosi and UNLOXCYT, as well as the advancement of its pipeline. The company expects research and development costs to decrease in 2025, which could help improve its financial performance.

Fortress’ partnership strategy, wherein it sources and develops assets through its subsidiaries, has been a key part of its business model. The successful acquisition of Caelum Biosciences by AstraZeneca in 2021 demonstrates the potential upside of this approach, as Fortress was able to generate significant value for its shareholders. Continued execution of this strategy, with prudent management of its subsidiaries, could unlock further value for Fortress.

However, the company faces several challenges that could impact its future prospects. The loss of eligibility to use Form S-3 and the associated “baby shelf” rules could make it more difficult for Fortress to raise capital through equity offerings. Additionally, the potential acquisition of Checkpoint Therapeutics by Sun Pharmaceutical, while providing a near-term financial benefit, could reduce Fortress’ exposure to a key late-stage asset.

Overall, Fortress Biotech remains a diversified biopharmaceutical company with a promising pipeline and commercial products, but it must continue to navigate the challenges of profitability and capital management to fully realize its potential. Prudent execution of its strategy, cost optimization, and effective management of its subsidiaries will be crucial in determining the company’s long-term success.

Risk Disclosure: The content of this page is not an investment advice and does not constitute any offer or solicitation to offer or recommendation of any investment product. It is for general purposes only and does not take into account your individual needs, investment objectives and specific financial circumstances. All investments involve risk and the past performance of securities, or financial products does not guarantee future results or returns. Keep in mind that while diversification may help spread risk it does not assure a profit, or protect against loss, in a down market. There is always the potential of losing money when you invest in securities, or other financial products. Investors should consider their investment objectives and risks carefully before investing. For more details, please refer to risk disclosure.
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