Fortress Biotech(US:FBIO)2024-05-15 20:20Q1 2024 Overview and Corporate Highlights CEO's Statement The CEO highlighted 7% product revenue growth in Q1 2024, driven by flagship products, alongside key regulatory milestones and anticipated approvals - Product revenue grew 7% year-over-year in Q1, primarily driven by over 20% growth in flagship products Qbrexza and Accutane2 - The company's late-stage pipeline may yield up to three regulatory approvals within the next 12 months, with a potential fourth BLA filing as early as 202512 - Multiple data readouts are anticipated in 2024, including topline data for AJ201, Phase 1b data for dotinurad, and Phase 2 data for Triplex2 Recent Corporate Highlights Significant pipeline progress reported, encompassing regulatory milestones, clinical advancements, commercial performance, and financing Regulatory Milestones and Updates Fortress achieved key regulatory milestones, including DFD-29 NDA acceptance, CUTX-101 submission, and planned cosibelimab BLA resubmission - The FDA accepted the New Drug Application (NDA) for DFD-29 for treating rosacea, with a PDUFA goal date of November 4, 202416 - The rolling NDA submission for CUTX-101 is ongoing and expected to be completed in 20246 - Following a Complete Response Letter (CRL) for cosibelimab citing third-party manufacturing issues, a BLA resubmission is targeted for mid-year 20246 - Partner AstraZeneca estimates it may submit the BLA for CAEL-101 for AL amyloidosis for FDA review as early as 20256 Clinical Updates Several clinical programs advanced, including Triplex Phase 2 enrollment, new Triplex study initiation, and anticipated dotinurad data - The Phase 2 clinical trial of Triplex in adults co-infected with HIV and CMV is fully enrolled, with topline data expected in Q4 20246 - The first patient was dosed in a multi-center Phase 2 study of Triplex for CMV control in liver transplant patients, funded by an NIH grant of over $20 million26 - Data from the ongoing Phase 1b clinical trial of dotinurad for gout and hyperuricemia is expected in mid-202426 Commercial Product Updates Journey Medical reported $13.0 million in total revenues for Q1 2024, representing a 7% increase year-over-year Journey Medical Total Revenues | Company | Metric | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | :--- | | Journey Medical | Total Revenues | $13.0 million | $12.2 million | +7% | General Corporate Fortress and partner companies completed several financing activities in early 2024, securing significant capital - In January 2024, Fortress raised gross proceeds of approximately $11.0 million in a registered direct offering9 - Partner companies Checkpoint and Avenue raised approximately $14.0 million and $5.0 million, respectively, in January 20249 - Subsequent to Q1, in May 2024, Avenue raised approximately $4.4 million and Mustang raised approximately $4.0 million9 Financial Results First Quarter 2024 Financial Performance Fortress reported $13.0 million in Q1 2024 net revenue, reduced operating expenses, and a net loss of $17.7 million Key Financial Highlights | Financial Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Consolidated Net Revenue | $13.0 million | $12.4 million | | R&D Expenses | $24.8 million | $39.5 million | | SG&A Costs | $17.9 million | $25.3 million | | Net Loss (to common stockholders) | $(17.7) million | $(23.5) million | | Net Loss per Share | $(1.03) | $(3.47) | Consolidated Cash Position | Cash Position | March 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Consolidated Cash | $85.8 million | $83.4 million | Financial Statements Unaudited Condensed Consolidated Balance Sheets Fortress Biotech reported total assets of $164.6 million, liabilities of $168.6 million, and a stockholders' deficit of $3.9 million Condensed Consolidated Balance Sheet Summary | Balance Sheet Item ($ in thousands) | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $83,774 | $80,927 | | Total Assets | $164,645 | $167,526 | | Total Liabilities | $168,582 | $165,939 | | Total stockholders' equity (deficit) | $(3,937) | $1,587 | Unaudited Condensed Consolidated Statements of Operations For Q1 2024, the company reported $13.0 million net revenue, reduced operating expenses, and an improved net loss of $17.7 million Condensed Consolidated Statements of Operations Summary | Statement of Operations ($ in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net revenue | $13,030 | $12,429 | | Total operating expenses | $49,596 | $71,296 | | Loss from operations | $(36,566) | $(58,867) | | Net loss attributable to common stockholders | $(17,731) | $(23,545) | | Net loss per common share | $(1.03) | $(3.47) |