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Delcath(DCTH) - 2023 Q4 - Annual Results
DelcathDelcath(US:DCTH)2024-03-26 11:48

Part I Business Highlights and Updates Delcath Systems achieved key milestones: first HEPZATO KIT commercial use, increased site activations, secured J-code, and strengthened its balance sheet - Announced the first commercial use of HEPZATO KIT™ for treating metastatic uveal melanoma (mUM) at Moffitt Cancer Center3 - Increased the 2024 treatment site activation guidance from 15 to 20 sites by year-end, with several sites already active or expected to be active shortly34 - Secured a permanent, product-specific J-code (J9248) and transitional pass-through payment status from CMS for HEPZATO, effective April 1, 2024, simplifying reimbursement3 - Raised $7.0 million in a private placement from existing investors, senior executives, and board members to strengthen the balance sheet35 - Appointed Martha S. Rook, Ph.D., as Chief Operating Officer, bringing over 25 years of industry experience in biologics and combination products manufacturing3 Financial Performance Delcath's 2023 financial performance showed decreased revenue, widened operating loss, and a strengthened cash position post-year-end financing Key Financial Metrics 2023 metrics show slight revenue decrease, reduced R&D, increased SG&A for HEPZATO KIT launch, and a $32.5 million year-end cash balance - As of December 31, 2023, cash, cash equivalents, and investments totaled $32.5 million. A subsequent private placement in March 2024 added $7.0 million5 Revenue Performance (in millions) | Period | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Q4 Revenue | $0.5 | $0.6 | -16.7% | | Full Year Revenue | $2.1 | $2.7 | -22.2% | Operating Expenses (in millions) | Expense Category | Full Year 2023 | Full Year 2022 | Change | | :--- | :--- | :--- | :--- | | Research & Development | $17.5 | $18.6 | -5.9% | | Selling, General & Admin | $22.1 | $17.3 | +27.7% | Consolidated Balance Sheets Delcath's 2023 balance sheet shows total assets increased to $38.6 million and a shift to $15.8 million stockholders' equity Selected Balance Sheet Data (in thousands) | Account | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash, cash equivalents & short-term investments | $32,454 | $7,671 | | Total Current Assets | $37,158 | $16,155 | | Total Assets | $38,613 | $17,862 | | Total Liabilities | $22,836 | $23,721 | | Total Stockholders' Equity (Deficit) | $15,777 | $(5,859) | Consolidated Statements of Operations Delcath's 2023 operations show $2.1 million total revenues, $38.2 million operating loss, and $47.7 million net loss or ($2.94) per share Full Year Statement of Operations Highlights (in thousands, except per share data) | Metric | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Total Revenues | $2,065 | $2,719 | | Gross Profit | $1,430 | $2,033 | | Operating Loss | $(38,182) | $(33,853) | | Net Loss | $(47,678) | $(36,508) | | Basic and Diluted Loss Per Share | $(2.94) | $(4.12) | Company and Product Overview Delcath Systems is an interventional oncology company focused on liver cancer treatment with HEPZATO KIT™ (U.S.) and CHEMOSAT® (Europe) - Delcath's core technology, percutaneous hepatic perfusion (PHP), administers high-dose chemotherapy (melphalan) to the liver while controlling systemic exposure8 - In the U.S., HEPZATO KIT™ is an FDA-approved drug/device combination for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases under specific conditions8 - In Europe, the product is regulated as a Class III medical device under the name CHEMOSAT® and is used to treat a wide range of liver cancers9 Safe Harbor / Forward-Looking Statements This section provides a standard safe harbor statement, noting forward-looking statements are subject to risks, especially for HEPZATO KIT commercialization and supply chain - The press release contains forward-looking statements regarding the company's plans and expectations10 - Identified risks include uncertainties related to commercialization plans, supply chain management, FDA inspections, and reimbursement for the HEPZATO KIT10