Delcath(DCTH)

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Friday's Biotech Bounce: Clinical Momentum Fuels Late-Day Gains
RTTNews· 2025-09-29 05:07
Core Insights - Several small- and mid-cap biotech and medical stocks experienced significant after-hours trading activity on September 26, driven by clinical updates, investor presentations, and strategic announcements. Company Summaries - **Enanta Pharmaceuticals Inc. (ENTA)**: The stock surged 20% in after-hours trading to $9.48 after closing at $7.90, following the announcement of upcoming topline results from its Phase 2b study on zelicapavir for RSV treatment in high-risk adults [2][3]. - **Acumen Pharmaceuticals Inc. (ABOS)**: Shares rebounded 12.67% to $1.60 after closing at $1.42, driven by renewed interest in its Alzheimer's pipeline, particularly the Phase 2 candidate Sabirnetug (ACU193) [4]. - **Delcath Systems Inc. (DCTH)**: The stock gained 6.00% in after-hours trading to $11.39 after closing at $10.74, following renewed investor interest in its CHOPIN Phase 2 trial data presentation scheduled for ESMO 2025 Congress [5][6]. - **Vivos Therapeutics Inc. (VVOS)**: The stock climbed 4.81% to $3.27 after closing at $3.12, likely due to renewed interest following recent positive clinical trial results for its pediatric OSA treatment [7][8]. - **Xilio Therapeutics (XLO)**: Shares rose 4.28% to $0.83 after closing at $0.7959, driven by enthusiasm surrounding the initiation of a Phase 2 trial for its tumor-activated IL-12 candidate, which also triggered a $17.5 million payment from Gilead [9][10]. - **Nyxoah SA (NYXH)**: The stock increased 3.77% to $4.68 after closing at $4.51, supported by optimism regarding its international expansion and a recent patent infringement lawsuit against Inspire Medical Systems [11].
Delcath Systems, Inc. (NASDAQ:DCTH) Financial Performance and Competitive Landscape
Financial Modeling Prep· 2025-09-16 00:00
Delcath Systems, Inc. (NASDAQ:DCTH) is a medical technology company focused on oncology. It develops and commercializes therapies for the treatment of primary and metastatic liver cancers. The company's main product is the Hepatic Delivery System, which administers high-dose chemotherapy to the liver while minimizing systemic exposure. Delcath operates in a competitive landscape with peers like Interpace Biosciences, EOM Pharmaceuticals Holdings, Aeterna Zentaris, and Rennova Health.In evaluating Delcath's ...
Delcath Systems (NasdaqCM:DCTH) FY Conference Transcript
2025-09-10 16:02
Summary of Delcath Systems FY Conference Call - September 10, 2025 Company Overview - **Company**: Delcath Systems (NasdaqCM:DCTH) - **Industry**: Oncology, specifically focused on liver cancers - **Lead Product**: HEPZATO KIT, a minimally invasive percutaneous perfusion technology launched in January 2024 for treating primary and secondary liver tumors [2][4] Core Business Strategy - **Initial Focus**: Targeting metastatic uveal melanoma, an ultra-orphan indication where the liver is often the life-limiting organ [4][5] - **Market Potential**: Over 100,000 patients annually in the U.S. have liver as a life-limiting organ due to cancer [4] - **Expansion Plans**: Revenue from the initial indication will fund expansion into other cancers, including metastatic colorectal cancer (40,000 patients annually), breast cancer, and pancreatic cancer [5][6] Competitive Advantages of HEPZATO KIT - **Unique Treatment Method**: Unlike other liver-directed therapies (Y-90, microwave ablation, TACE), HEPZATO KIT perfuses the entire liver with chemotherapy, allowing for treatment of multiple small metastases that are not visible on imaging [6][7][8] - **Liver Function Preservation**: High doses of melphalan can be administered without losing liver function, unlike other methods that can compromise liver health [8] Commercial Growth and Center Activation - **Current Status**: 22 active commercial centers in the U.S. with plans to grow to 40 centers next year [9][10] - **Revenue Guidance**: Revised guidance for the year is $93 million to $96 million, with growth linked to the number of active centers [9][10] - **Procedure Volume**: Average of two procedures per center per month, with potential for growth through referrals and operational improvements [10][14] Training and Operational Challenges - **Team Composition**: Each treatment team consists of an Interventional Radiologist, Anesthesiologist, and Perfusionist, which requires coordination and training [18][19] - **Training Complexity**: Training involves didactic learning and proctoring, which can be logistically challenging [18][19] Medicaid National Drug Rebate Agreement (NDRA) - **Impact on Revenue**: NDRA participation results in a 11% to 13% decrease in revenue per kit, affecting Q3 financials but potentially increasing patient access [20][23] - **Reimbursement Changes**: New guidelines have expanded the number of customers under NDRA, which may help in patient access despite the revenue decrease [21][24] Clinical Development and Future Indications - **Current Trials**: Ongoing trials for metastatic colorectal cancer and breast cancer, with interim data expected in 1997-1998 [25][26] - **Future Studies**: Potential for additional studies based on the safety and efficacy of combining HEPZATO with immuno-oncology agents [27] Financial Health - **Cash Position**: Company is cash positive with no debt, indicating a strong financial position for future growth [29][30][32] Conclusion - **Outlook**: Delcath Systems is positioned for growth with a unique product offering in the oncology space, a solid commercial strategy, and a focus on expanding treatment indications while maintaining a strong financial position [29][30]
Delcath Systems, Inc. (DCTH) Surpasses Q2 Earnings and Revenue Estimates
ZACKS· 2025-08-06 14:16
Delcath Systems, Inc. (DCTH) came out with quarterly earnings of $0.07 per share, beating the Zacks Consensus Estimate of $0.02 per share. This compares to a loss of $0.48 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +250.00%. A quarter ago, it was expected that this company would post earnings of $0.1 per share when it actually produced earnings of $0.03, delivering a surprise of -70%. Over the last four quarters, the com ...
Delcath(DCTH) - 2025 Q2 - Earnings Call Transcript
2025-08-06 13:30
Financial Data and Key Metrics Changes - Quarterly revenue reached $24.2 million, an increase of over 20% compared to the same period in 2024, reflecting continued strong adoption [6][17] - Net income for the second quarter was $2.7 million, compared to a net loss of $13.7 million in the same quarter of the previous year [18] - Adjusted EBITDA for the second quarter was $9.8 million, compared to an adjusted EBITDA loss of $0.8 million for the same period in 2024 [18] - The company ended the quarter with approximately $81 million in cash and investments and generated $7.3 million in positive cash from operations [6][18] Business Line Data and Key Metrics Changes - U.S. sales of hepcidol were $22.5 million, while Kenosat sales in Europe were $1.7 million, showing significant growth from $6.6 million and $1.2 million respectively in the same period of 2024 [17] - Gross margins improved to 86% in the second quarter compared to 80% for the same period in the prior year [17] Market Data and Key Metrics Changes - The total hepcido treatment volume in 2025 is projected to increase by over 175% versus 2024 [10] - The company anticipates 25 to 28 operational centers by the end of the fourth quarter, with a goal of 40 sites by the end of next year [9][10] Company Strategy and Development Direction - The company is intentionally scaling by targeting world-class cancer centers to expand the use of hepcido into pipeline indications with larger patient populations [7] - Plans are underway to enter into the National Drug Rebate Agreement (NDRA) with the U.S. Department of Health and Human Services to increase market access [10][11] - The company is investing in further research and development for Hepsato, with preparations for trials in liver-dominant metastatic colorectal cancer and breast cancer [13][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continuing to open sites, despite slower U.S. site activations, and adjusted full-year revenue guidance to $93 million to $96 million [10][12] - Management noted that the complexities of working with large institutions for a novel product are reflected in the pace of site openings [8][9] - The management team emphasized the importance of physician interest and patient outcomes as primary drivers for growth [36][70] Other Important Information - Research and development expenses for the quarter were $6.9 million, compared to $3.4 million for the same period in the prior year [17] - Selling, general, and administrative expenses for the second quarter were $11.4 million, compared to $6.8 million for the same period in the previous year [18] Q&A Session Summary Question: Insights on NDRA program and its impact on volumes - Management indicated it is premature to assess any tailwinds from the NDRA program, but noted that centers are pleased with the participation [20][21] Question: Update on sales team expansion - The expansion of the sales team is complete, with six regions now staffed with dedicated personnel for clinical support and site management [24][25] Question: Long-term volume potential with NDRA - Management discussed the potential for increased volume but emphasized the difficulty in quantifying the impact of the NDRA program [28][30] Question: Urgency from centers post-NDRA - Management noted no increased urgency from centers to activate, as many factors still influence the approval process [35][36] Question: R&D spending outlook - R&D expenses are expected to increase significantly in the coming quarters as trials ramp up [37][38] Question: ESMO presentation capacity - Management confirmed that MSLs will be able to discuss the outcomes of the CHOPEN trial at the ESMO conference [42][43] Question: Adjustments to active site guidance - The adjustment in active site guidance was due to the complexities of activating large academic centers [61][62] Question: Onboarding and training process improvements - Management is implementing strategies to streamline the onboarding process and improve training efficiency [75][79] Question: Impact of clinical programs on ChemoSAT sales - Long-term benefits for ChemoSAT sales are anticipated as new clinical sites open, but significant impacts will take time [82]
Delcath(DCTH) - 2025 Q2 - Quarterly Report
2025-08-06 13:14
[PART I—FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) This section presents the company's financial statements and management's discussion and analysis for the reporting period [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements and related notes [Unaudited Condensed Consolidated Balance Sheets](index=4&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) This statement provides a snapshot of the company's assets, liabilities, and equity at specific points in time Condensed Consolidated Balance Sheet Highlights | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | Change (in thousands) | % Change | | :-------------------------------- | :----------------------------- | :------------------------------- | :-------------------- | :------- | | **Assets** | | | | | | Cash and cash equivalents | $34,421 | $32,412 | $2,009 | 6.19% | | Short-term investments | $46,584 | $20,821 | $25,763 | 123.74% | | Total current assets | $113,482 | $73,760 | $39,722 | 53.85% | | Total assets | $116,876 | $76,589 | $40,287 | 52.60% | | **Liabilities** | | | | | | Total current liabilities | $10,435 | $6,144 | $4,291 | 69.84% | | Total liabilities | $11,890 | $7,843 | $4,047 | 51.60% | | **Stockholders' Equity** | | | | | | Total stockholders' equity | $104,986 | $68,746 | $36,240 | 52.72% | - Total assets increased by **$40.3 million (52.6%)** from December 31, 2024, to June 30, 2025, primarily driven by a significant increase in short-term investments and cash and cash equivalents[11](index=11&type=chunk) - Total stockholders' equity increased by **$36.2 million (52.7%)** over the six-month period, reflecting net income and additional paid-in capital[11](index=11&type=chunk) [Unaudited Condensed Consolidated Statements of Operations and Comprehensive Income and Loss](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20and%20Loss) This statement details the company's revenues, expenses, and net income or loss over specific periods Condensed Consolidated Statements of Operations Highlights (Three Months Ended June 30) | Metric (in thousands) | 2025 | 2024 | Change | % Change | | :-------------------------------- | :----- | :----- | :----- | :------- | | Product revenue | $24,156 | $7,766 | $16,390 | 211.05% | | Gross profit | $20,838 | $6,247 | $14,591 | 233.58% | | Operating income (loss) | $2,590 | $(3,912) | $6,502 | -166.21% | | Net income (loss) | $2,697 | $(13,741) | $16,438 | -119.63% | | Basic income (loss) per common share | $0.08 | $(0.48) | $0.56 | -116.67% | | Diluted income (loss) per common share | $0.07 | $(0.48) | $0.55 | -114.58% | Condensed Consolidated Statements of Operations Highlights (Six Months Ended June 30) | Metric (in thousands) | 2025 | 2024 | Change | % Change | | :-------------------------------- | :----- | :----- | :----- | :------- | | Product revenue | $43,940 | $10,905 | $33,035 | 302.93% | | Gross profit | $37,777 | $8,483 | $29,294 | 345.32% | | Operating income (loss) | $3,232 | $(14,190) | $17,422 | -122.78% | | Net income (loss) | $3,766 | $(24,852) | $28,618 | -115.15% | | Basic income (loss) per common share | $0.11 | $(0.93) | $1.04 | -111.83% | | Diluted income (loss) per common share | $0.09 | $(0.93) | $1.02 | -109.68% | - Product revenue for the three months ended June 30, 2025, increased by **211.05% to $24.2 million**, and for the six months ended June 30, 2025, increased by **302.93% to $43.9 million**, compared to the same periods in 2024[13](index=13&type=chunk) - The company reported net income of **$2.7 million** for the three months and **$3.8 million** for the six months ended June 30, 2025, a significant improvement from net losses of **$(13.7) million** and **$(24.9) million**, respectively, in the prior year periods[13](index=13&type=chunk) [Unaudited Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) This statement tracks changes in the company's equity from various sources over specific periods Stockholders' Equity Changes (Six Months Ended June 30, 2025) | Item (in thousands) | Amount | | :-------------------------------- | :----- | | Balance at January 1, 2025 | $68,746 | | Compensation expense for stock options | $13,972 | | Compensation expense for ESPP | $100 | | Issuance of common stock (ESPP) | $238 | | Warrant Exercise - Series F | $16,158 | | Stock Option Exercise | $1,496 | | Net income | $3,766 | | Unrealized gain on investment adjustments | $296 | | Foreign currency translation adjustments | $214 | | Balance at June 30, 2025 | $104,986 | - Total stockholders' equity increased from **$68.7 million** at January 1, 2025, to **$105.0 million** at June 30, 2025, driven by net income, stock-based compensation, and proceeds from warrant and stock option exercises[16](index=16&type=chunk) - Common stock shares outstanding increased from **33,061,002** at January 1, 2025, to **34,955,974** at June 30, 2025, primarily due to warrant and stock option exercises[16](index=16&type=chunk) [Unaudited Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This statement summarizes the cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows Highlights (Six Months Ended June 30) | Cash Flow Activity (in thousands) | 2025 | 2024 | Change | | :-------------------------------- | :----- | :----- | :----- | | Net cash provided by (used in) operating activities | $9,496 | $(14,035) | $23,531 | | Net cash (used in) provided by investing activities | $(25,563) | $14,944 | $(40,507) | | Net cash provided by financing activities | $17,892 | $1,167 | $16,725 | | Net increase in total cash | $2,009 | $2,086 | $(77) | | End of period cash and cash equivalents | $34,421 | $14,782 | $19,639 | - Net cash provided by operating activities significantly improved to **$9.5 million** for the six months ended June 30, 2025, compared to **$14.0 million** used in the same period in 2024[20](index=20&type=chunk) - Cash flows from investing activities shifted from a net inflow of **$14.9 million** in 2024 to a net outflow of **$25.6 million** in 2025, primarily due to increased purchases of investments[20](index=20&type=chunk) - Net cash provided by financing activities increased substantially to **$17.9 million** in 2025 from **$1.2 million** in 2024, mainly driven by proceeds from warrant exercises[20](index=20&type=chunk) [Notes to the Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed explanations of the accounting policies and specific financial statement items [(1) General](index=10&type=section&id=%281%29%20General) This note provides an overview of Delcath Systems, Inc., its primary business focus on interventional oncology with its lead product HEPZATO KIT and CHEMOSAT, and assesses the company's liquidity - Delcath's lead product, **HEPZATO KIT**, received FDA approval on August 14, 2023, for uveal melanoma with unresectable hepatic metastases, with its first commercial use in January 2024[23](index=23&type=chunk) - The company is conducting Phase 2 clinical trials for HEPZATO in liver-dominant metastatic colorectal cancer (IND cleared December 2024, patient enrollment H2 2025) and liver-dominant metastatic breast cancer (IND cleared April 2025, patient enrollment Q4 2025)[28](index=28&type=chunk)[30](index=30&type=chunk)[31](index=31&type=chunk) - As of June 30, 2025, the company had **$34.4 million** in cash and cash equivalents and **$46.6 million** in short-term investments, believing these resources are sufficient for at least 12 months of operations[37](index=37&type=chunk)[38](index=38&type=chunk) [(2) Revenue](index=14&type=section&id=%282%29%20Revenue) This note details the company's revenue recognition policies for HEPZATO KIT in the US and CHEMOSAT in Europe, provides a breakdown of product revenue, and highlights customer concentration Revenue by Product (in thousands) | Product | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | CHEMOSAT | $1,656 | $1,196 | $3,417 | $2,327 | | HEPZATO KIT | $22,500 | $6,570 | $40,523 | $8,578 | | Total revenue | $24,156 | $7,766 | $43,940 | $10,905 | - **HEPZATO KIT** revenue saw substantial growth, increasing from **$6.6 million** to **$22.5 million (242.5%)** for the three months ended June 30, 2025, and from **$8.6 million** to **$40.5 million (372.4%)** for the six months ended June 30, 2025, compared to the prior year[49](index=49&type=chunk) - The company entered into the National Drug Rebate Agreement (NDRA) with CMS, subjecting it to Medicaid rebates, Pharmaceutical Pricing Agreement (PPA) for 340B pricing, and a master agreement with the U.S. Department of Veterans Affairs (VA) for Federal Ceiling Price sales, effective July 1, 2025[51](index=51&type=chunk) [(3) Investments](index=17&type=section&id=%283%29%20Investments) This note summarizes the company's marketable debt securities, classified as available-for-sale and carried at fair value Marketable Securities (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :------------------------ | :------------ | :---------------- | | Amortized Cost | $46,153 | $20,686 | | Gross Unrealized Gains | $431 | $135 | | Estimated Fair Value | $46,584 | $20,821 | - The fair value of short-term investments, primarily U.S. government agency bonds, increased significantly from **$20.8 million** at December 31, 2024, to **$46.6 million** at June 30, 2025[52](index=52&type=chunk)[53](index=53&type=chunk) [(4) Inventory](index=17&type=section&id=%284%29%20Inventory) This note provides a breakdown of the company's inventory, including raw materials, work-in-process, and finished goods Inventory Breakdown (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :--------------- | :------------ | :---------------- | | Raw materials | $7,227 | $3,849 | | Work-in-process | $2,339 | $2,260 | | Finished goods | $957 | $824 | | Total inventory | $10,523 | $6,933 | - Total inventory increased by **$3.6 million (51.8%)** from **$6.9 million** at December 31, 2024, to **$10.5 million** at June 30, 2025, primarily due to an increase in raw materials[54](index=54&type=chunk) - Approximately **$0.6 million** in finished goods were held on consignment at hospitals and treatment centers as of June 30, 2025[54](index=54&type=chunk) [(5) Prepaid Expenses and Other Current Assets](index=18&type=section&id=%285%29%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) This note details the components of prepaid expenses and other current assets, highlighting significant increases in clinical trial expenses and professional services Prepaid Expenses and Other Current Assets (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Clinical trial expenses | $2,405 | $222 | | Professional services | $1,249 | $762 | | Interest receivable | $448 | $125 | | Total prepaid expenses and other current assets | $6,118 | $2,704 | - Prepaid expenses and other current assets more than doubled, increasing from **$2.7 million** at December 31, 2024, to **$6.1 million** at June 30, 2025, largely driven by a significant rise in prepaid clinical trial expenses[55](index=55&type=chunk) [(6) Property, Plant, and Equipment](index=18&type=section&id=%286%29%20Property%2C%20Plant%2C%20and%20Equipment) This note outlines the company's property, plant, and equipment, net of accumulated depreciation, and provides estimated useful lives for various asset categories Property, Plant, and Equipment, Net (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Property, plant and equipment, gross | $7,504 | $6,744 | | Accumulated depreciation | $(5,103) | $(4,954) | | Property, plant and equipment, net | $2,401 | $1,790 | - Net property, plant, and equipment increased by **$0.6 million (34.1%)** from **$1.8 million** at December 31, 2024, to **$2.4 million** at June 30, 2025[56](index=56&type=chunk) [(7) Accrued Expenses](index=18&type=section&id=%287%29%20Accrued%20Expenses) This note details the composition of accrued expenses, including clinical expenses, compensation, professional fees, and inventory-related accruals Accrued Expenses (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :------------------------ | :------------ | :---------------- | | Clinical expenses | $1,095 | $615 | | Compensation, excluding taxes | $2,891 | $3,471 | | Professional fees | $305 | $57 | | Total accrued expenses | $5,603 | $5,078 | - Total accrued expenses increased by **$0.5 million (10.3%)** from **$5.1 million** at December 31, 2024, to **$5.6 million** at June 30, 2025, primarily due to higher clinical expenses and professional fees[57](index=57&type=chunk) [(8) Leases](index=19&type=section&id=%288%29%20Leases) This note describes the company's operating lease arrangements for facilities in the U.S. and Ireland, including the Queensbury Lease initiated in January 2024 Operating Lease Liabilities (in thousands) | Category | U.S. | Ireland | Total | | :-------------------------------------------------------------------------------- | :----- | :------ | :------ | | Operating lease liabilities included in the condensed consolidated balance sheets at June 30, 2025 | $944 | $49 | $993 | - The company entered into a new Queensbury Lease in January 2024 for manufacturing and office space in New York, with an annual rent expense of less than **$0.2 million** for a five-year term[61](index=61&type=chunk) - Total operating lease liabilities were **$993 thousand** as of June 30, 2025, with remaining maturities totaling **$1.37 million** before present value discount[62](index=62&type=chunk) [(9) Stockholders' Equity](index=19&type=section&id=%289%29%20Stockholders%27%20Equity) This note details changes in stockholders' equity, including public and private placements, authorized and outstanding shares, and equity incentive plans - As of June 30, 2025, **34,955,974** shares of common stock were issued and outstanding, compared to **33,061,002** shares at December 31, 2024[11](index=11&type=chunk) - The company has a 2020 Omnibus Equity Incentive Plan with **9,325,000** shares reserved, of which **2,382,636** shares remained available for issuance as of June 30, 2025[69](index=69&type=chunk) Stock Option Activity (Six Months Ended June 30, 2025) | Metric | Number of Options | Weighted Average Exercise Price Per Share | | :-------------------------- | :---------------- | :---------------------------------------- | | Outstanding at January 1, 2025 | 5,766,927 | $7.23 | | Granted | 2,632,163 | $15.76 | | Exercised | (243,684) | $6.14 | | Outstanding at June 30, 2025 | 8,082,243 | $10.01 | Share-Based Compensation Expense (in thousands) | Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Selling, general and administrative | $4,718 | $1,930 | $9,247 | $3,971 | | Research and development | $1,773 | $895 | $3,341 | $1,543 | | Cost of goods sold | $718 | $244 | $1,484 | $500 | | Total | $7,209 | $3,069 | $14,072 | $6,014 | [(10) Net Income (Loss) per Share](index=25&type=section&id=%2810%29%20Net%20Income%20%28Loss%29%20per%20Share) This note explains the calculation of basic and diluted net income (loss) per share, providing a reconciliation of weighted average shares outstanding Weighted Average Shares Outstanding (Six Months Ended June 30) | Metric | 2025 | 2024 | | :-------------------------------- | :----------- | :----------- | | Weighted average number of basic shares outstanding | 35,217,887 | 26,625,955 | | Weighted average number of diluted shares outstanding | 39,890,102 | 26,625,955 | - Basic EPS for the six months ended June 30, 2025, was **$0.11**, a significant improvement from **$(0.93)** in the prior year, reflecting the company's net income[13](index=13&type=chunk) - Potentially dilutive securities, including common stock warrants, preferred stock, and stock options, totaling **2,818,739** for the six months ended June 30, 2025, were excluded from diluted EPS calculation as their effects were anti-dilutive[80](index=80&type=chunk) [(11) Income Taxes](index=26&type=section&id=%2811%29%20Income%20Taxes) This note addresses the company's income tax provision, valuation allowance against deferred tax assets, and the impact of recent tax legislation - The company recorded an income tax provision of **$0.7 million** for the six months ended June 30, 2025, compared to no provision in the same period of 2024[81](index=81&type=chunk) - The company maintains a valuation allowance against the full amount of its net deferred tax assets[82](index=82&type=chunk) - The recently signed One Big Beautiful Bill (OBBB) is being evaluated for its impact on future financial statements, particularly regarding the full expensing of U.S. research and development costs and changes to Section 163(j) taxable income base[85](index=85&type=chunk)[86](index=86&type=chunk) [(12) Commitments and Contingencies](index=28&type=section&id=%2812%29%20Commitments%20and%20Contingencies) This note details the company's commitments and contingencies, including the settlement of the medac matter, manufacturing and supply agreements, and clinical trial support - The company has an estimated remaining fair value of **$0.8 million** for the medac settlement as of June 30, 2025, with **$0.2 million** recorded as accrued expenses and **$0.6 million** as non-current other liabilities[89](index=89&type=chunk) - A Supply Agreement with Synerx Pharma, LLC and Mylan Teoranta for melphalan was extended through December 31, 2028, with **$2.1 million** of melphalan received in 2025[90](index=90&type=chunk) - The company has made **$2.3 million** in deposits for clinical trial support, including a Clinical Research Organization (CRO) engagement for Phase 2 trials in mCRC and HER2-negative mBC[91](index=91&type=chunk) [(13) Fair Value Measurements](index=29&type=section&id=%2813%29%20Fair%20Value%20Measurements) This note describes the company's fair value measurements, classifying financial assets and liabilities into Level 1, Level 2, and Level 3 categories Fair Value Measurements (in thousands) - June 30, 2025 | Category | Level 1 | Level 2 | Level 3 | Total | | :------------------------ | :------ | :------ | :------ | :------ | | **Assets:** | | | | | | Money market funds | $8 | — | — | $8 | | U.S. government agency bonds | — | $46,584 | — | $46,584 | | Total Assets | $8 | $46,584 | — | $46,592 | | **Liabilities:** | | | | | | Contingent Liability | — | — | $802 | $802 | | Total Liabilities | — | — | $802 | $802 | - The contingent liability related to the medac settlement, classified as Level 3, had a balance of **$802 thousand** at June 30, 2025, down from **$974 thousand** at January 1, 2025, due to liability payments and fair value adjustments[94](index=94&type=chunk) [(14) Segment Information](index=30&type=section&id=%2814%29%20Segment%20Information) This note states that the company operates as a single reportable segment focused on the research, development, manufacture, and distribution of hepatic delivery systems - Delcath Systems, Inc. operates as a single reportable segment, focusing on hepatic delivery systems for cancer treatment[98](index=98&type=chunk) - The company's CODM, comprising the CFO, COO, CMO, and General Manager, assesses financial performance using consolidated gross profit and net income or loss[98](index=98&type=chunk) [(15) Subsequent Events](index=30&type=section&id=%2815%29%20Subsequent%20Events) The company has evaluated subsequent events through the date of this report and has not identified any recordable or disclosable events not already reported - No recordable or disclosable subsequent events were identified through the report date[99](index=99&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations [Company Overview](index=32&type=section&id=Company%20Overview) Delcath Systems, Inc. is an interventional oncology company focused on liver cancer treatments, with its lead product HEPZATO KIT and advancing Phase 2 clinical trials - **HEPZATO KIT** received FDA approval on August 14, 2023, for uveal melanoma with unresectable hepatic metastases, with the first commercial use in January 2024[105](index=105&type=chunk) - The company's IND for a Phase 2 clinical trial evaluating HEPZATO in liver-dominant metastatic colorectal cancer was cleared by the FDA in December 2024, with patient enrollment expected in the second half of 2025. The estimated total addressable market for this indication is **6,000 to 10,000 patients annually** in the U.S[113](index=113&type=chunk) - The IND for a Phase 2 clinical trial of HEPZATO in liver-dominant HER2-negative metastatic breast cancer was cleared by the FDA on April 28, 2025, with patient enrollment expected in Q4 2025. Approximately **7,000 patients annually** in the U.S. are candidates for third-line treatment in this population[114](index=114&type=chunk)[115](index=115&type=chunk) [Results of Operations](index=35&type=section&id=Results%20of%20Operations) The company experienced substantial financial improvement for the three and six months ended June 30, 2025, driven by significant increases in product revenue and improved profitability Key Financial Results (in thousands) | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | :----------------------------- | :----------------------------- | | Total revenues | $24,156 | $7,766 | $43,940 | $10,905 | | Gross profit | $20,838 | $6,247 | $37,777 | $8,483 | | Operating income (loss) | $2,590 | $(3,912) | $3,232 | $(14,190) | | Net income (loss) | $2,697 | $(13,741) | $3,766 | $(24,852) | - Total revenue for the six months ended June 30, 2025, increased by **302.9% to $43.9 million**, compared to **$10.9 million** in the same period of 2024, primarily due to the commercial expansion of HEPZATO in the U.S. and CHEMOSAT in Europe[118](index=118&type=chunk)[119](index=119&type=chunk) - Research and development expenses increased to **$11.9 million** for the six months ended June 30, 2025, from **$7.1 million** in 2024, driven by expanding the clinical team and initiating Phase 2 trials for mCRC and mBC[118](index=118&type=chunk)[121](index=121&type=chunk) - Selling, general and administrative expenses rose to **$22.7 million** for the six months ended June 30, 2025, from **$15.6 million** in 2024, due to continued commercial expansion activities and increased personnel-related share-based compensation[118](index=118&type=chunk)[122](index=122&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity significantly improved, with cash and short-term investments totaling **$81.0 million** at June 30, 2025, and sufficient resources for at least the next 12 months Liquidity Position (in millions) | Metric | June 30, 2025 | December 31, 2024 | | :------------------------ | :------------ | :---------------- | | Cash and cash equivalents | $34.4 | $32.4 | | Short-term investments | $46.6 | $20.8 | | Total cash and investments | $81.0 | $53.2 | - Cash provided by operating activities was **$9.5 million** for the six months ended June 30, 2025, a significant improvement from **$14.0 million** used in operating activities during the same period in 2024[124](index=124&type=chunk)[125](index=125&type=chunk) - The company has capital commitments of **$10.4 million** over the next twelve months, including accounts payable, accrued expenses, current lease liabilities, and current medac settlement[127](index=127&type=chunk) - A universal shelf registration statement on Form S-3, effective August 5, 2024, allows the company to offer and sell up to **$150 million** in various securities[128](index=128&type=chunk) [Critical Accounting Estimates](index=37&type=section&id=Critical%20Accounting%20Estimates) There have been no material changes to the company's critical accounting estimates as reported in its Annual Report on Form 10-K filed on March 6, 2025 - No material changes to critical accounting estimates since the 2024 Annual Report on Form 10-K[130](index=130&type=chunk) [Application of Critical Accounting Policies](index=37&type=section&id=Application%20of%20Critical%20Accounting%20Policies) There were no material changes to the company's critical accounting policies as reported in its Annual Report on Form 10-K - No material changes to critical accounting policies since the 2024 Annual Report[131](index=131&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not required for the company - This disclosure item is not required for the company[132](index=132&type=chunk) [Item 4. Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting - The company's disclosure controls and procedures were deemed effective as of June 30, 2025[134](index=134&type=chunk) - No material changes in internal control over financial reporting occurred during the six months ended June 30, 2025[136](index=136&type=chunk) [PART II—OTHER INFORMATION](index=40&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) This section covers legal proceedings, risk factors, and other disclosures not included in the financial statements [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company is subject to claims in the ordinary course of business, which could result in litigation - Claims are made against the company in the ordinary course of business, which could lead to litigation[139](index=139&type=chunk) - Details on the medac matter are provided in Note 12, 'Commitment and Contingencies - medac Matter'[140](index=140&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) This section updates the company's risk factors, including those related to governmental pricing and tax laws - Failure to comply with reporting and payment obligations under governmental pricing programs (Medicaid Drug Rebate Program, 340B program, VA/FSS pricing) could result in penalties, sanctions, and fines[143](index=143&type=chunk)[144](index=144&type=chunk)[146](index=146&type=chunk) - Changes in healthcare law and implementing regulations, such as the One Big Beautiful Bill (OBBB) and the Inflation Reduction Act (IRA), could significantly impact the company's business by reducing Medicaid spending, affecting Medicare drug price negotiations, and altering access to health insurance[150](index=150&type=chunk)[151](index=151&type=chunk)[152](index=152&type=chunk) - New or changed tax laws, including the OBBB's restoration of R&D expensing, could adversely affect the company's business operations and financial performance[155](index=155&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=43&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is not applicable to the company for the reporting period - This item is not applicable[156](index=156&type=chunk) [Item 3. Defaults Upon Senior Securities](index=43&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company for the reporting period - This item is not applicable[157](index=157&type=chunk) [Item 4. Mine Safety Disclosure](index=43&type=section&id=Item%204.%20Mine%20Safety%20Disclosure) This item is not applicable to the company for the reporting period - This item is not applicable[158](index=158&type=chunk) [Item 5. Other Information](index=44&type=section&id=Item%205.%20Other%20Information) During the three months ended June 30, 2025, no Section 16 officers and directors adopted, modified, or terminated Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements - No Section 16 officers or directors adopted, modified, or terminated Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements during the three months ended June 30, 2025[159](index=159&type=chunk) [Item 6. Exhibits](index=45&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including amendments to the Certificate of Incorporation, By-Laws, equity incentive plans, and certifications - Exhibits include various corporate governance documents (e.g., Certificate of Incorporation, By-Laws), equity incentive plans (2020 Omnibus Equity Incentive Plan, 2021 Employee Stock Purchase Plan, 2023 Inducement Plan), and certifications required by the Sarbanes-Oxley Act[160](index=160&type=chunk) [SIGNATURES](index=48&type=section&id=SIGNATURES) The report is duly signed on behalf of Delcath Systems, Inc. by its Chief Executive Officer and Chief Financial Officer - The Form 10-Q was signed by Gerard Michel, Chief Executive Officer, and Sandra Pennell, Chief Financial Officer, on August 6, 2025[166](index=166&type=chunk)
Is the Options Market Predicting a Spike in Delcath Systems Stock?
ZACKS· 2025-07-17 13:35
Company Overview - Delcath Systems, Inc. (DCTH) is currently experiencing significant activity in the options market, particularly with the Aug 15, 2025 $7.5 Call option showing high implied volatility, indicating potential for a major price movement [1] - The company holds a Zacks Rank of 3 (Hold) within the Medical - Instruments industry, which is positioned in the bottom 35% of the Zacks Industry Rank [3] Analyst Insights - Over the past 60 days, one analyst has raised the earnings estimate for the current quarter, while no analysts have lowered their estimates, resulting in a shift of the Zacks Consensus Estimate from breakeven earnings per share to 2 cents [3] - The high implied volatility suggests that options traders are anticipating a significant price movement for Delcath Systems shares, which could indicate a developing trading opportunity [4] Options Trading Strategy - Options traders often seek out options with high implied volatility to sell premium, a strategy that aims to benefit from the decay of option value over time [4]
Delcath Systems (DCTH) Earnings Call Presentation
2025-06-17 07:33
Company Overview - Delcath is focused on liver-dominant cancers with a high unmet medical need[16, 22] - The company's lead product is the HEPZATO KIT, a liver-directed treatment for metastatic uveal melanoma (mUM)[38] - Delcath has an experienced management team with expertise in commercializing high-value, specialty products[10, 14, 100] - The company has a strong financial position with $58.9 million in cash and investments as of March 31, 2025, and no outstanding debt obligations[15] HEPZATO KIT Commercialization - HEPZATO KIT received FDA approval in August 2023 for mUM[17] - In Q1 2025, total revenue was $19.8 million with gross margins of 86%[14] - Full-year revenue guidance for 2025 is $94 to $98 million[14] - The company is expanding its commercial presence, with 19 active centers as of May 8, 2025, and 29 sites accepting referrals[65] - The US mUM total addressable market (TAM) is approximately $500 million[15] Clinical Development and Pipeline - Delcath has IND approval for Phase 2 trials in metastatic colorectal cancer (mCRC) and metastatic breast cancer (mBC)[14] - Phase 2 trials for mCRC and mBC are planned to initiate enrollment in Q3/Q4 2025 and Q4 2025, respectively[17] - The company is evaluating HEPZATO in combination with SOC (trifluridine-tipiracil and bevacizumab) in liver-dominant mCRC, enrolling approximately 90 patients[17] - The company is also evaluating HEPZATO in combination with SOC (eribulin, vinorelbine or capecitabine) in liver-dominant HER2-negative mBC, enrolling approximately 90 patients[18] Financial Performance - Q1 2025 net income was $1.1 million, and adjusted EBITDA was $7.6 million (Non-GAAP)[15] - Q1 2025 operating cash flow was $2.2 million[15] - The company received approximately $16 million from warrant exercises through May 5th at a $10 strike price[15]
Delcath Systems: Growing Fast, But Business Model Is Fragile
Seeking Alpha· 2025-06-12 12:36
Group 1 - Delacth has experienced strong growth for its HEPZATO treatment and trades at an attractive valuation [1] - Delacth faces both current and future competitive pressures that will likely weigh down sentiment and valuation multiples [1] Group 2 - The author identifies key information from earnings transcripts and reports that signify growth, having studied hundreds of earnings reports [2] - The author successfully identified future winners such as OPRX, OTRK, FUBO, and PLUG through careful analysis [2]
Delcath Systems, Inc. (DCTH) Is Up 0.62% in One Week: What You Should Know
ZACKS· 2025-06-04 17:01
Company Overview - Delcath Systems, Inc. (DCTH) currently holds a Momentum Style Score of A, indicating strong potential for momentum investing [3] - The company has a Zacks Rank of 2 (Buy), suggesting favorable market performance [4] Performance Metrics - DCTH shares have increased by 0.62% over the past week, outperforming the Zacks Medical - Instruments industry, which rose by 0.37% [6] - Over the past month, DCTH's price change is 37.2%, significantly higher than the industry's 1.13% [6] - In the last quarter, DCTH shares have risen by 36.27%, and over the past year, they have gained 149.3%, while the S&P 500 has only moved 2.37% and 14.4%, respectively [7] Trading Volume - The average 20-day trading volume for DCTH is 588,239 shares, which serves as a bullish indicator when combined with rising stock prices [8] Earnings Outlook - In the past two months, one earnings estimate for DCTH has increased, while none have decreased, raising the consensus estimate from $0.28 to $0.29 [10] - For the next fiscal year, one estimate has also moved upwards with no downward revisions during the same period [10] Conclusion - Given the strong performance metrics and positive earnings outlook, DCTH is positioned as a promising momentum pick for investors [12]