
Business Highlights and Operational Updates Delcath achieved significant Q1 2024 progress in HEPZATO KIT's commercial launch, marked by strong revenue, increased active center guidance, and key operational milestones Q1 2024 Product Revenue | Product | Revenue (USD) | | :--- | :--- | | HEPZATO KIT | $2.0 million+ | | CHEMOSAT | $1.1 million | - Updated U.S. center activation guidance, increasing the target from 15 to 20 active centers by the end of 20242 - Raised $7.0 million in a private placement from existing investors, senior executives, and board members2 - Received a permanent, product-specific J-code (J9248) and transitional pass-through payment status for HEPZATO KIT from CMS, effective April 1, 20242 - Appointed Martha S. Rook, Ph.D, as Chief Operating Officer2 - Extended the supply agreement for melphalan hydrochloride with Synerx Pharma, LLC and Mylan Teoranta to December 31, 20282 First Quarter 2024 Financial Performance Delcath's Q1 2024 revenue increased to $3.1 million, but operating loss widened to $10.3 million due to higher SG&A, ending the quarter with $27.2 million in cash Q1 2024 Key Financial Metrics (YoY Comparison) | Metric | Q1 2024 (USD) | Q1 2023 (USD) | Change | | :--- | :--- | :--- | :--- | | Total Revenue | $3.1 million | $0.6 million | +417% | | R&D Expenses | $3.7 million | $4.6 million | -19.6% | | SG&A Expenses | $8.8 million | $4.2 million | +110% | | Operating Loss | ($10.3 million) | ($8.3 million) | +24% | | Cash Position | $27.2 million | N/A | N/A | Condensed Consolidated Statements of Operations Q1 2024 total revenues surged to $3.1 million, increasing gross profit, but higher SG&A expenses led to a widened operating loss of $10.3 million and a net loss of $11.1 million Q1 2024 Statement of Operations (in thousands, except per share data) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Total Revenues | $3,139 | $597 | | Gross Profit | $2,236 | $416 | | Research and development expenses | $3,700 | $4,576 | | Selling, general and administrative expenses | $8,814 | $4,165 | | Operating loss | $(10,278) | $(8,325) | | Net loss | $(11,111) | $(9,000) | | Basic and diluted loss per common share | $(0.45) | $(0.77) | Condensed Consolidated Balance Sheets As of March 31, 2024, Delcath held $27.2 million in cash and investments, with total assets at $36.1 million and total liabilities decreasing to $21.5 million Balance Sheet Highlights (in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $11,760 | $12,646 | | Short-term investments | $15,360 | $19,808 | | Total current assets | $33,646 | $37,158 | | Total assets | $36,099 | $38,613 | | Total current liabilities | $13,341 | $16,448 | | Total liabilities | $21,479 | $22,836 | | Total stockholders' equity | $14,620 | $15,777 | Company Information and Forward-Looking Statements Delcath Systems is an interventional oncology company focused on liver cancer treatment with HEPZATO KIT in the U.S. and CHEMOSAT in Europe, providing standard forward-looking statement disclaimers - Delcath is an interventional oncology company focused on treating primary and metastatic liver cancers6 - HEPZATO KIT is approved in the U.S. for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and limited or no extrahepatic disease6 - In Europe, the device component is regulated as a Class III medical device and sold under the name CHEMOSAT7 - The press release contains forward-looking statements subject to risks and uncertainties, including commercialization, supply chain management, and reimbursement8