Company Performance - Fortress Biotech reported a quarterly loss of $0.26 per share, significantly better than the Zacks Consensus Estimate of a loss of $0.79, and an improvement from a loss of $0.53 per share a year ago, resulting in an earnings surprise of 67.09% [1] - The company posted revenues of $15.12 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 12.58%, and down from $19.95 million in the same quarter last year [2] - Fortress Biotech has surpassed consensus EPS estimates three times over the last four quarters but has not beaten consensus revenue estimates during the same period [2] Stock Performance - Fortress Biotech shares have declined approximately 20.5% since the beginning of the year, compared to a decline of 5.1% for the S&P 500 [3] - The current Zacks Rank for Fortress Biotech is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $1.47 on revenues of $11.84 million, while for the current fiscal year, the estimate is -$1.13 on revenues of $155.67 million [7] - The estimate revisions trend for Fortress Biotech is mixed, and changes in these estimates could occur following the recent earnings report [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Fortress Biotech belongs, is currently ranked in the top 27% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]

Financial Performance - Total net revenue for the years ended December 31, 2024 and 2023 was $57.7 million and $84.5 million, respectively, with net product revenue from Journey's commercial portfolio at $55.1 million and $59.7 million[394]. - For the year ended December 31, 2024, the company generated net revenue of $57.7 million, a decrease of $26.8 million or 32% from $84.5 million in 2023[428]. - Product revenue decreased by $4.5 million or 8% to $55.1 million, primarily due to higher managed care rebate costs and lower unit volumes from legacy products[429]. - The company reported a net loss of $120.9 million for 2024, a reduction of $33.3 million or 22% compared to a net loss of $154.2 million in 2023[425]. - Total operating expenses decreased by $58.8 million or 26% to $168.1 million in 2024 from $226.9 million in 2023[425]. - The cost of goods sold decreased by $2.0 million or 9% to $20.9 million in 2024, attributed to lower royalties and a decrease in sales[430]. - Collaboration revenue fell by $3.7 million or 71% to $1.5 million in 2024, compared to $5.2 million in 2023[426]. - The total cash decrease for the year ended December 31, 2024, was $24.6 million, compared to a decrease of $97.6 million in 2023, reflecting a significant improvement of $73.0 million[486]. Research and Development - Research and development expenses were approximately $56.6 million in 2024, down $45.1 million or 44% from $101.7 million in 2023[434]. - The company expects research and development costs to decrease in 2025[439]. - Research and development expenses for licenses acquired dropped by $4.1 million or 94% to $252,000 in 2024, due to the absence of comparable transactions[440]. - Stock-based compensation expense included in R&D increased by $3.9 million or 120% to $7.1 million in 2024, primarily due to performance-based vesting at Checkpoint[437]. Equity and Financing Activities - Fortress raised total net proceeds of approximately $21.1 million through equity offerings throughout 2024[412]. - Checkpoint raised total net proceeds of approximately $32.8 million through equity offerings and warrant exercises throughout 2024[412]. - Mustang raised total net proceeds of approximately $11.2 million through equity offerings and warrant exercises throughout 2024[412]. - Avenue raised total net proceeds of approximately $9.8 million through equity offerings and warrant exercises throughout 2024[412]. - Fortress entered into a new $50 million term loan with Oaktree Capital Management, borrowing $35 million initially and having the option to draw an additional $15 million[406]. - Fortress entered into a $50.0 million senior secured credit agreement in July 2024, borrowing $35.0 million initially, with a maturity date of July 25, 2027[481]. - Journey entered into a Credit Agreement with SWK Funding LLC for a term loan facility of up to $25 million, with $15 million drawn on December 27, 2023, and the remaining $10 million drawn upon FDA approval of Emrosi[485]. Regulatory Approvals and Product Developments - Checkpoint received FDA approval for UNLOXCYT (cosibelimab-ipdl) for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma on December 13, 2024[394]. - Emrosi (Minocycline Hydrochloride Extended-Release Capsules) was approved by the FDA in November 2024 for the treatment of inflammatory lesions of rosacea, with a launch planned for March 2025[394]. - Cyprium announced that the FDA accepted the NDA for CUTX-101 for priority review, with a target action date of September 30, 2025[398]. - Mustang's MB-101 CAR T-cell therapy showed a 50% stable disease or better rate in high-grade glioma patients, with two complete responses lasting over 66 months[402]. - Updated data for MB-106 indicated a 90% overall response rate in patients with Waldenstrom macroglobulinemia, including three complete responses[402]. Cash Flow and Liquidity - Net cash used in operating activities decreased by $48.0 million from 2023 to 2024, primarily due to a decrease in net loss of $33.3 million and a one-time recovery payment of $4.6 million[487]. - Net cash used by investing activities increased from $2.1 million in 2023 to $15.0 million in 2024, due to a $15 million milestone payment triggered by FDA approval of Emrosi[488]. - Net cash provided by financing activities increased by $37.9 million from 2023 to 2024, driven by proceeds from long-term debt of $33.7 million and common stock issuance of $17.4 million[490]. - The company reported a net cash outflow from operating activities of $80.2 million for the year ended December 31, 2024, compared to $128.2 million in 2023[491]. Stock and Shareholder Actions - Fortress announced a pause in dividend payments on its 9.375% Series A Preferred Stock, deferring approximately $0.7 million in cash dividends each month[406]. - Mustang executed a 1-for-50 reverse stock split to comply with Nasdaq listing requirements[406]. - Avenue's common stock began trading under the symbol "ATXI" on the OTC Markets system after receiving a notice of suspension from Nasdaq[406]. - Journey issued approximately 1.6 million shares of common stock at an average price of $5.19 per share for net proceeds of $7.9 million in 2024[461]. - Checkpoint received approximately $9.2 million from the exercise of Series B warrants to purchase 3,256,269 shares of common stock in November 2024[463]. - Checkpoint closed a registered direct offering in July 2024, issuing 1,230,000 shares at $2.05 per share, raising approximately $11.0 million in net proceeds[464]. - Mustang sold approximately $4.4 million of securities under its 2021 S-3 registration statement in 2024, prior to its expiration[466]. - Avenue raised approximately $4.5 million from the exercise of existing warrants in January 2024, after deducting fees[477]. Other Significant Events - Journey received a $19.0 million upfront payment for the exclusive license of certain rights relating to Qbrexza in Asia, included in total net revenue for 2023[394]. - Urica entered into a transaction with Crystalys Therapeutics, transferring rights to dotinurad and receiving 35% equity in Crystalys along with a 3% royalty on future net sales[402]. - Fortress's Board of Directors approved a workforce reduction of approximately 81% to reduce costs and preserve capital[412]. - Mustang recorded an asset impairment of $3.7 million in 2024, a 17% increase from the $3.1 million impairment in 2023[449]. - Journey recorded a loss recovery benefit of $4.6 million related to a cybersecurity incident, received in cash in December 2024[448]. - Total other expense decreased by $1.1 million, or 10%, from $11.3 million in 2023 to $10.2 million in 2024[452]. - As of December 31, 2024, the company had cash and cash equivalents of $57.3 million, with $20.9 million related to Fortress and private subsidiaries[454].

Financial Performance - Fortress Biotech reported consolidated net revenue of $57.7 million for the full year ended December 31, 2024, down from $84.5 million in 2023, with dermatology product revenue decreasing from $59.7 million to $55.1 million[14]. - Fortress Biotech reported a net revenue of $57.675 million for the year ended December 31, 2024, a decrease of 31.7% compared to $84.513 million in 2023[19]. - Product revenue, net, was $55.134 million in 2024, down from $59.662 million in 2023, reflecting a decline of 7.5%[19]. - The net loss attributable to common stockholders was $(55.9) million, or $(2.69) per share, for 2024, an improvement from a net loss of $(68.7) million, or $(8.47) per share, in 2023[14]. - The net loss attributable to common stockholders for 2024 was $55.890 million, compared to a net loss of $68.669 million in 2023, showing an improvement of 18.5%[19]. - Fortress Biotech's net loss per common share attributable to common stockholders was $(2.69) in 2024, compared to $(8.47) in 2023, indicating a significant reduction in loss per share[19]. Expenses - Consolidated research and development expenses totaled $56.9 million for 2024, a significant decrease from $106.1 million in 2023[14]. - Research and development expenses were $56.629 million in 2024, down 44.4% from $101.747 million in 2023[19]. - Consolidated selling, general and administrative costs were $87.7 million for 2024, compared to $91.0 million in 2023[14]. - Total operating expenses decreased to $168.054 million in 2024 from $226.855 million in 2023, a reduction of 26%[19]. - The company reported a loss from operations of $110.379 million in 2024, an improvement from a loss of $142.342 million in 2023[19]. Cash and Assets - Fortress' cash and cash equivalents totaled $57.3 million as of December 31, 2024, down from $80.9 million at the end of 2023[14]. - Fortress Biotech's cash and cash equivalents decreased to $57.263 million as of December 31, 2024, from $80.927 million in 2023, a decline of 29%[18]. - Fortress Biotech's total assets decreased to $144.223 million in 2024 from $167.526 million in 2023, a decline of 13.9%[18]. - The company’s accumulated deficit increased to $(740.867) million in 2024 from $(694.870) million in 2023[18]. Strategic Developments - Fortress' subsidiary Checkpoint Therapeutics is set to be acquired by Sun Pharma, with Fortress expecting to receive approximately $28 million at closing and a 2.5% royalty on net sales of UNLOXCYT[2]. - The FDA accepted the New Drug Application for CUTX-101, with a PDUFA goal date of September 30, 2025[2]. - The commercial launch of Emrosi for treating inflammatory lesions of rosacea is underway, with initial prescriptions filled[2]. - Fortress raised total net proceeds of approximately $21.1 million through equity offerings in 2024[10]. - Fortress entered into a strategic collaboration with Partex NV to evaluate biopharmaceutical compounds using artificial intelligence for potential acquisition or licensing[10].

Core Insights - Fortress Biotech, Inc. announced significant developments including FDA approvals for Emrosi™ and UNLOXCYT™, and the acceptance of a New Drug Application for CUTX-101, indicating a transformative fourth quarter for the company [2][7] - The acquisition of Checkpoint Therapeutics by Sun Pharma is expected to enhance patient access to UNLOXCYT and provide Fortress with approximately $28 million at closing, along with a 2.5% royalty on net sales [2][3] - Fortress aims to leverage its pipeline of late clinical-stage candidates and recently approved products to drive revenue growth and shareholder value [2][10] Recent Corporate Highlights - Fortress' subsidiary Checkpoint Therapeutics is set to be acquired by Sun Pharma, with Fortress holding approximately 6.9 million shares of Checkpoint and eligible for a 2.5% royalty on future sales of UNLOXCYT [3] - The acquisition agreement includes an upfront cash payment of $4.10 per share for Checkpoint stockholders, plus a contingent value right potentially worth an additional $0.70 [3] - Fortress raised approximately $21.1 million through equity offerings in 2024, while Checkpoint raised about $32.8 million during the same period [11] Regulatory Updates - The FDA approved Emrosi (Minocycline Hydrochloride Extended-Release Capsules, 40mg) for treating inflammatory lesions of rosacea in November 2024, with commercial launch initiated in March 2025 [7][2] - UNLOXCYT was approved by the FDA in December 2024 for treating metastatic or locally advanced cutaneous squamous cell carcinoma [7] - The FDA accepted the New Drug Application for CUTX-101 for priority review, with a PDUFA goal date set for September 30, 2025 [7][2] Clinical Updates - Phase 3 clinical trials for Emrosi demonstrated its efficacy, safety, and tolerability in treating moderate-to-severe papulopustular rosacea, with results published in the Journal of the American Medical Association - Dermatology [7] - Clinical data for UNLOXCYT presented at the European Society for Medical Oncology Congress 2024 showed improved response rates over time [7] - A Phase 2 clinical trial for Triplex, a cytomegalovirus vaccine, commenced in January 2025, targeting patients undergoing hematopoietic stem cell transplantation [7] Financial Results - Fortress reported consolidated net revenue of $57.7 million for the year ended December 31, 2024, down from $84.5 million in 2023, with product revenue from dermatology products totaling $55.1 million [10][17] - Consolidated research and development expenses decreased to $56.9 million in 2024 from $106.1 million in 2023 [10][17] - The net loss attributable to common stockholders was $(55.9) million, or $(2.69) per share, for the year ended December 31, 2024, compared to a net loss of $(68.7) million, or $(8.47) per share, in 2023 [10][17]

Financial Data and Key Metrics Changes - Journey Medical reported annual revenue of $56 million in 2024, a decrease from $79 million in 2023, primarily due to higher rebate costs and lower unit volumes from legacy products [10][26] - Total net product revenue for 2024 was $55.1 million, down from $59.7 million in 2023 [26] - The net loss for 2024 was $14.7 million, or $0.72 per share, compared to a net loss of $3.9 million, or $0.21 per share in 2023 [30] - Non-GAAP adjusted EBITDA for 2024 was positive $800,000, down from $15.6 million in 2023 [31][32] - Cash and cash equivalents as of December 31, 2024, were $20.3 million, down from $27.4 million at the end of 2023 [32] Business Line Data and Key Metrics Changes - Research and development expenses increased by $2.3 million to $9.9 million in 2024, driven by non-recurring payments related to Emrosi's NDA filing [28][29] - Selling, general and administrative (SG&A) expenses decreased by $3.7 million to $40.2 million in 2024, attributed to expense optimization efforts [30] Market Data and Key Metrics Changes - Emrosi is entering a treatment category valued at over $1 billion, with expectations for significant operating leverage as it gains market traction [13][14] - As of early 2025, approximately 20% of commercial lives and 4% of Medicare lives have coverage for Emrosi, with expectations for substantial increases throughout the year [18][19] Company Strategy and Development Direction - The company is focused on the launch of Emrosi, which is expected to be a major growth driver, with peak annual sales estimated at $200 million in the U.S. and $100 million internationally [34] - Journey Medical plans to continue attending and presenting at dermatology-focused medical congresses throughout 2025 to promote Emrosi [23][35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the launch of Emrosi and its potential to transform the business, highlighting the positive reception from dermatologists at recent conferences [15][17] - The company anticipates a ramp-up in payer coverage and prescription demand over the next 12 to 18 months [40][41] Other Important Information - Journey Medical completed a total of $22 million in FDA filing fees and milestone payments related to Emrosi in 2024 [11] - The company has received a $1 million milestone payment following regulatory approval for Amzeeq in China [27] Q&A Session Summary Question: What should be expected for payer coverage by the end of 2025? - Management expects peak commercial coverage to take 12 to 18 months, with ongoing efforts to increase covered lives [38][40] Question: How important was the erythema data to KOLs at AAD? - The head-to-head performance data was of significant interest, while erythema data was not a primary focus [42][44] Question: Thoughts on 2025 guidance? - Guidance for 2025 will be provided later in the year after assessing initial Emrosi prescription demand [52][54] Question: How has the reimbursement environment been? - Early indications show that around 20% coverage is on target, with prescriptions starting to come in [56][57] Question: Will Q1 report meaningful revenues from Emrosi? - Minimal revenues are expected in Q1, with more significant contributions anticipated in Q2 [59] Question: How is pricing across the legacy portfolio expected to change? - Pricing for legacy brands is expected to hold steady, with some erosion in volume due to competition [80][81] Question: What are the main bottlenecks for the Emrosi launch? - Supply and formulary coverage are key areas of focus, with ample supply already secured [86][88] Question: Will there be any pricing moves by competitors post-launch? - No significant pricing movements from competitors have been observed since the launch [104]

FRANKFURT, Germany and MIAMI, March 17, 2025 (GLOBE NEWSWIRE) -- Partex NV and Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company, today announced a strategic collaboration aimed at identifying and evaluating biopharmaceutical compounds using artificial intelligence (AI) for potential acquisition or licensing by Fortress. Partex will deploy its proprietary AI-based drug discovery and development technology platform, which delivers diverse recommendations on alternati ...

WORCESTER, Mass., Feb. 10, 2025 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. ("Mustang" or the "Company") (NASDAQ:MBIO), a clinical-stage biopharmaceutical company focused on translating today's medical breakthroughs in cell therapies into potential cures for difficult-to-treat cancers, today announced the closing of its previously announced public offering, for the issuance and sale of an aggregate of 2,657,807 shares of its common stock (or common stock equivalents in lieu thereof), Series C-1 warrants to purcha ...

WORCESTER, Mass., Feb. 06, 2025 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. ("Mustang" or the "Company") (NASDAQ:MBIO), a clinical-stage biopharmaceutical company focused on translating today's medical breakthroughs in cell therapies into potential cures for difficult-to-treat cancers, today announced the pricing of a public offering of an aggregate of 2,657,807 shares of its common stock (or common stock equivalents in lieu thereof), Series C-1 warrants to purchase up to 2,657,807 shares of common stock and Seri ...

Study is the first randomized, controlled trial examining a vaccine's effectiveness in controlling CMV in recipients of HSCT from vaccinated donors Encouraging pilot study results demonstrated the benefit of vaccinating donors with Triplex to convey protective CMV-specific T cell immunity to allogeneic HSCT recipients at risk for CMV reactivation MIAMI, Jan. 27, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ:FBIO) ("Fortress"), and its majority-owned subsidiary, Helocyte, Inc. ("Helocyte"), today a ...

Reverse Stock Split - Mustang Bio Inc announced a 1-for-50 reverse stock split of its issued and outstanding common stock, effective from January 16, 2025 [1] - The reverse stock split was approved by the Board of Directors and stockholders representing approximately 56% of the voting power on June 27, 2024 [2] - The number of outstanding shares will be reduced from approximately 64.8 million to approximately 1.3 million, with no fractional shares issued and proportional cash payments made instead [3] Compliance and Trading Details - The reverse stock split aims to bring the company into compliance with Nasdaq's $1.00 per share minimum bid price requirement for continued listing [2] - Mustang's common stock will continue to trade on Nasdaq under the symbol "MBIO" with a new CUSIP number of 62818Q302 [3] - VStock Transfer LLC is acting as the exchange and paying agent for the reverse stock split, providing instructions for physical share certificate exchanges [4] Company Overview - Mustang Bio Inc is a clinical-stage biopharmaceutical company focused on developing cell therapies for difficult-to-treat cancers [5] - The company partners with top medical institutions to advance CAR-T therapies and aims to license or acquire technologies for research and development [5] - Mustang was founded by Fortress Biotech Inc and its common stock is registered under the Securities Exchange Act of 1934 [5]