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]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 _____________________ FORM 10-Q ______________________ x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 Or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 DELCATH SYSTEMS, INC. (Exact name of registrant as specified in its charter) ______________________ Delaware 06-1245881 (State or other ju ...

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]

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]

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]

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]

Investors interested in Medical stocks should always be looking to find the best-performing companies in the group. Has Benitec Biopharma Limited (BNTC) been one of those stocks this year? A quick glance at the company's year-to-date performance in comparison to the rest of the Medical sector should help us answer this question.Benitec Biopharma Limited is a member of our Medical group, which includes 999 different companies and currently sits at #4 in the Zacks Sector Rank. The Zacks Sector Rank includes 1 ...

Core Viewpoint - Delcath Systems, Inc. (DCTH) has seen a 34.5% increase in share price over the past four weeks, closing at $16.41, with analysts suggesting a potential upside of 48.7% based on a mean price target of $24.40 [1][11]. Price Targets and Analyst Estimates - The mean estimate for DCTH comprises five short-term price targets with a standard deviation of $2.97, indicating a range of estimates from a low of $21 (28% increase) to a high of $29 (76.7% increase) [2][9]. - A low standard deviation suggests a high degree of agreement among analysts regarding the stock's price movement, which can serve as a starting point for further research [9]. Earnings Estimates and Market Sentiment - Analysts are optimistic about DCTH's earnings prospects, as indicated by a positive trend in earnings estimate revisions, which have increased by 3.6% over the past month with no negative revisions [11][12]. - DCTH holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, further supporting the potential for upside [13].

Core Viewpoint - The article emphasizes the importance of identifying and maintaining trends in short-term investing, highlighting that sound fundamentals and positive earnings estimates are crucial for sustaining momentum in stocks [1]. Group 1: Recent Price Strength Screen - The "Recent Price Strength" screen is a unique short-term trading strategy that helps investors shortlist stocks with strong fundamentals capable of maintaining an uptrend [2]. - Stocks that pass this screen are typically trading in the upper portion of their 52-week high-low range, indicating bullish sentiment [2]. Group 2: Delcath Systems, Inc. (DCTH) - Delcath Systems, Inc. (DCTH) has shown a solid price increase of 19.2% over the past 12 weeks, indicating investor confidence in its potential upside [3]. - DCTH has experienced a price increase of 34.5% over the last four weeks, suggesting that the upward trend is still intact [4]. - Currently, DCTH is trading at 84.7% of its 52-week high-low range, indicating a potential breakout opportunity [4]. Group 3: Fundamental Strength - DCTH holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises [5]. - The Zacks Rank system has a strong track record, with Zacks Rank 1 stocks averaging an annual return of +25% since 1988 [6]. - DCTH also has an Average Broker Recommendation of 1 (Strong Buy), reflecting high optimism from the brokerage community regarding its near-term price performance [6]. Group 4: Additional Investment Opportunities - Besides DCTH, there are several other stocks that meet the criteria of the "Recent Price Strength" screen, suggesting further investment opportunities [7]. - The article encourages exploring over 45 Zacks Premium Screens tailored to different investing styles to identify potential winning stocks [7].

Company Performance - Delcath Systems, Inc. (DCTH) reported quarterly earnings of $0.03 per share, missing the Zacks Consensus Estimate of $0.10 per share, compared to a loss of $0.43 per share a year ago, representing an earnings surprise of -70% [1] - The company posted revenues of $19.78 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 9.24%, and this is a significant increase from year-ago revenues of $3.14 million [2] - Over the last four quarters, Delcath Systems has surpassed consensus EPS estimates two times and topped consensus revenue estimates three times [2] Stock Outlook - The sustainability of Delcath Systems' stock price movement will depend on management's commentary during the earnings call and future earnings expectations [3] - The stock has lost about 3.6% since the beginning of the year, while the S&P 500 has declined by 4.3% [3] - The current consensus EPS estimate for the coming quarter is $0.08 on revenues of $19.75 million, and for the current fiscal year, it is $0.28 on revenues of $82.26 million [7] Industry Context - The Medical - Instruments industry, to which Delcath Systems belongs, is currently in the top 28% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5] - Mesa Labs (MLAB), another company in the same industry, is expected to report quarterly earnings of $2.75 per share, with revenues projected to be $63.1 million, reflecting a year-over-year increase of 7.1% [9]