Delcath Systems, Inc. (DCTH) closed the last trading session at $14.26, gaining 0.1% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $22.60 indicates a 58.5% upside potential.The average comprises five short-term price targets ranging from a low of $21 to a high of $25, with a standard deviation of $1.82. While the lowest estimate indicates an increase of 47.3% from the current pri ...

Company Overview - Atyr Pharma (ATYR) is part of the Medical sector, which includes 1012 individual stocks and currently holds a Zacks Sector Rank of 4, indicating its relative strength within the sector [2] - Atyr Pharma belongs to the Medical - Biomedical and Genetics industry, which consists of 510 individual stocks and is currently ranked 73 in the Zacks Industry Rank [6] Performance Metrics - Atyr Pharma has returned 6.9% year-to-date, outperforming the Medical sector's average return of 4.8% [4] - The Zacks Consensus Estimate for Atyr Pharma's full-year earnings has increased by 19.4% over the past quarter, reflecting stronger analyst sentiment and an improving earnings outlook [4] - The Medical - Biomedical and Genetics industry has gained an average of 6.3% year-to-date, indicating that Atyr Pharma is performing better than its industry peers [6] Comparative Analysis - Delcath Systems, Inc. (DCTH), another Medical stock, has outperformed the sector with a year-to-date return of 11.6% and a significant increase of 132.9% in its consensus EPS estimate over the past three months [5] - Delcath Systems operates in the Medical - Instruments industry, which has seen a decline of 3.5% year-to-date and is currently ranked 129 [7]

Financial Data and Key Metrics Changes - In 2024, the company generated $32.3 million in HEPZATO revenue in the U.S., including $13.7 million in Q4 from 14 active treatment centers [9][24] - The company achieved a positive adjusted EBITDA of $4.6 million in Q4, marking the first time the company reached this milestone [11][26] - The company ended the year with $53.2 million in cash and investments, with no debt [11][23] Business Line Data and Key Metrics Changes - HEPZATO sales for Q4 were $13.7 million, while CHEMOSAT sales were $1.4 million, up from $0.5 million in Q4 2023 [24] - Full year 2024 revenue for HEPZATO was $32.3 million, and CHEMOSAT was $4.9 million, compared to $2.1 million for CHEMOSAT in 2023 [24] - Gross margins were reported at 86% for Q4 and 83% for the full year [25] Market Data and Key Metrics Changes - CHEMOSAT volumes in Europe grew 137% in 2024, with Germany up 75% and other markets like the UK and Turkey doubling year-over-year [16] - The company activated three new U.S. treatment centers in Q4 and has plans to reach 30 active centers by year-end 2025 [12][14] Company Strategy and Development Direction - The company aims to expand its R&D capabilities to maximize the hepatic delivery system's potential for treating other liver-dominant cancers [11][21] - The strategic value of the European presence lies in supporting clinical trials and generating publications, with plans to expand into France, Italy, and Spain in 2025 [17] - The company is increasing its commercial team and expanding from four to six regions to enhance operational efficiency [14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, stating that the first year of HEPZATO's U.S. launch has been a success and has brought the company close to cash flow break-even [22][23] - The company plans to continue investing in high-impact R&D initiatives while maintaining a focus on revenue growth [23] Other Important Information - The company received over $41 million in proceeds from the exercise of warrants during the year [11] - The SCANDIUM 3 trial in Sweden began screening patients, and the CHOPIN trial in the Netherlands completed enrollment with 76 patients [18][19] Q&A Session Summary Question: Changes in treatment cycles with new sites for HEPZATO - Management noted that the average treatment rate per site is expected to remain steady at around 4.1 treatments, similar to the FOCUS trial [31][32] Question: SG&A ramp with expansion plans - SG&A expenses are expected to increase by 30% to 40% in 2025, with most expenses starting in the second quarter [39] Question: R&D expenses and cash flow - Management indicated that while they expect to be cash flow positive, they will prioritize R&D opportunities over maintaining positive cash flow [47][48] Question: Price increase for HEPZATO - A price increase of approximately 2.74% was implemented, with future increases dependent on inflation rates [49][50] Question: Referral network effectiveness - The referral network is functioning well, with community centers referring patients to larger academic centers [56] Question: Expansion of treatment indications - Management confirmed that no device modifications are necessary for new indications, and they are focusing on engaging existing treatment sites [41] Question: Expectations for European market growth - Management anticipates modest growth in Europe, contingent on reimbursement developments [76][78] Question: Timeline for activating new treatment centers - More centers are expected to come online in the second half of the year, with a goal of reaching 30 active centers by year-end [88] Question: Competitive landscape for HEPZATO - Management believes that HEPZATO will complement systemic therapies, emphasizing the need for liver-directed treatments [94][96]

Corporate Presentation 2 NASDAQ: DCTH March 2025 Forward-Looking Statement The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This presentation contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potenti ...

Group 1: Earnings Performance - Delcath Systems, Inc. reported quarterly earnings of $0.05 per share, exceeding the Zacks Consensus Estimate of a loss of $0.10 per share, compared to a loss of $0.48 per share a year ago, representing an earnings surprise of 150% [1] - The company posted revenues of $15.1 million for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 33.04%, compared to year-ago revenues of $0.54 million [2] - Over the last four quarters, Delcath Systems has surpassed consensus EPS estimates two times and topped consensus revenue estimates two times [2] Group 2: Stock Performance and Outlook - Delcath Systems shares have increased approximately 11.6% since the beginning of the year, while the S&P 500 has declined by 0.7% [3] - The current consensus EPS estimate for the coming quarter is -$0.17 on revenues of $11.9 million, and for the current fiscal year, it is -$0.41 on revenues of $62.3 million [7] - The estimate revisions trend for Delcath Systems is favorable, leading to a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] Group 3: Industry Context - The Medical - Instruments industry, to which Delcath Systems belongs, is currently in the top 34% of over 250 Zacks industries, suggesting a positive outlook for stocks within this sector [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Performance - As of December 31, 2024, the company had $32.4 million in cash and cash equivalents and $20.8 million in short-term investments, with net losses of approximately $26.4 million and $47.7 million for the years ended December 31, 2024 and 2023, respectively[142]. - Total revenues for the year ended December 31, 2024, were approximately $37.2 million, a significant increase from $2.1 million in 2023, driven by the commercial launch of the HEPZATO KIT in the U.S.[332][333]. - The net loss for the year ended December 31, 2024, was $26.4 million, compared to a net loss of $47.7 million in 2023[332]. - The company used $18.7 million and $31.3 million in cash for operating activities during the years ended December 31, 2024, and 2023, respectively[316]. - Selling, general and administrative expenses rose to $29.6 million in 2024, an increase of 34% from $22.1 million in 2023, mainly due to expenses related to commercial launch activities[337]. - Research and development expenses decreased to $13.9 million in 2024 from $17.5 million in 2023, a reduction of 21%, primarily due to lower costs associated with the NDA submission[335]. Commercialization Efforts - The commercialization of HEPZATO in the United States began in 2024 following FDA approval in August 2023, and its success is critical for the company's profitability[155]. - The company may require additional substantial financing to further commercialize HEPZATO and CHEMOSAT or to conduct future product development, including clinical trials[146]. - The ability to generate additional product revenue from HEPZATO and CHEMOSAT depends on various factors, including market acceptance and reimbursement from third-party payors[144]. - The company has limited experience in establishing a sales and marketing infrastructure, which may impede the commercialization of CHEMOSAT and HEPZATO in various markets[170]. - If the company fails to establish effective sales and marketing capabilities, it may not successfully commercialize HEPZATO or other product candidates[172]. - The potential market opportunity for CHEMOSAT and HEPZATO is difficult to estimate, and if actual market sizes are smaller than anticipated, revenue growth may be adversely affected[183]. Regulatory and Compliance Risks - Regulatory compliance is critical; failure to maintain it could result in loss of marketing approval and adversely affect financial conditions[199]. - The company is subject to extensive ongoing regulatory obligations, including post-marketing testing and compliance with REMS requirements for HEPZATO[195]. - The company relies on third parties for conducting clinical trials, which may impact the timing and success of obtaining regulatory approvals[204]. - The lack of adequate reimbursement from government and private payors may significantly limit sales opportunities for CHEMOSAT and HEPZATO in Europe[208]. - Healthcare reforms in the U.S. and abroad may limit the commercialization and demand for CHEMOSAT and HEPZATO[210]. Supply Chain and Manufacturing - The company faces risks related to the supply of melphalan, a critical component for HEPZATO and CHEMOSAT, which could impact commercialization efforts[157]. - The company is currently reliant on one supplier for melphalan and is in discussions with other potential suppliers to mitigate supply interruption risks[161]. - Manufacturing of CHEMOSAT and HEPZATO is conducted at the company's facility in Queensbury, New York, with additional operations in Galway, Ireland, but reliance on third-party suppliers may lead to delays in component availability, impacting product delivery[164]. - Delays in manufacturing could hinder the company's ability to obtain regulatory approval for other indications, affecting clinical trial timelines and commercialization efforts[165]. Intellectual Property and Legal Risks - The company faces risks related to intellectual property rights, which may not provide adequate protection against competitors, potentially allowing them to compete more effectively[229]. - The complexity and uncertainty of European patent laws have increased, particularly with the introduction of the new unitary patent system in June 2023, which could impact the enforcement of patents[231]. - The company may face expensive and time-consuming litigation to protect its intellectual property, with no guarantee of a favorable outcome[236]. - Changes in patent law could diminish the value of patents, impacting the company's ability to protect its products and technologies[244]. Market and Competitive Landscape - The company faces intense competition in the cancer treatment industry, with competitors having greater resources and experience, which could impact revenue and profitability[180]. - The commercial success of CHEMOSAT and HEPZATO depends on acceptance by the medical community and third-party payors as clinically useful and cost-effective[211]. - The healthcare industry is experiencing significant consolidation, leading to potential price concessions and increased pressure on product pricing, particularly for CHEMOSAT and HEPZATO[228]. Financial Position and Future Outlook - The company has a substantial accumulated deficit and recurring operating losses, which adversely affect stockholders' equity and working capital[144]. - Future product development and commercialization efforts may be delayed or limited if the company cannot raise additional funds or generate significant revenue[151]. - The company may pursue agreements with additional contract manufacturers for melphalan and other critical components, but may face challenges in obtaining these on commercially reasonable terms, which could adversely affect revenues and profitability[163]. - The company is considering strategic alternatives, including potential acquisitions, but currently has no agreements in place[265]. Stock and Shareholder Information - The closing trading price of the company's common stock has fluctuated between a high of $12.64 on December 2, 2024, and a low of $3.72 on March 14, 2024[255]. - As of December 31, 2024, there are 33,061,002 shares of common stock issued and outstanding, with an additional 13,539,532 shares reserved for future issuance[260]. - The company has never declared or paid any dividends and does not expect to do so in the foreseeable future, relying on stock appreciation for returns[264]. - The company may face significant costs from potential class action securities litigation due to volatility in its trading price and volume[259]. Economic and External Factors - Economic downturns, inflation, and geopolitical conflicts could negatively impact the company's financial performance[283]. - The Federal Reserve's interest rate hikes may increase economic uncertainty and affect the company's ability to obtain financing[284]. - Potential downgrades of the United States credit rating could adversely impact the company's liquidity and financial condition[285].

Financial Overview - As of December 31, 2024, the company reported cash and investments totaling $53.2 million[9] - The company anticipates a cash burn of $3.6 million for Q3 2024, with expectations for cash flow positivity in the near future[11] - The company has no outstanding debt obligations, enhancing its financial stability[11] - The company has an expected cash and investments balance of $53.2 million and no outstanding debt obligations[73] Revenue and Market Potential - Preliminary Q4 2024 revenue is expected to be $15.1 million, with gross margins between 80% and 85%[10] - Fourth quarter revenue is expected to be approximately $15 million, with full year total revenue around $37 million, reflecting a 39% increase[73] - Revenue growth is primarily driven by HEPZATO activation, which has shown a 150% increase[73] - The total addressable market (TAM) for metastatic uveal melanoma (mUM) in the US is approximately $600 million[11] - The U.S. incidence of liver-dominant cancers is approximately 50,000 annually, indicating a significant market opportunity[70] Product Development and Clinical Trials - The HEPZATO KIT is the first and only FDA-approved whole-liver directed therapy, targeting unresectable hepatic metastases[10] - The company plans to initiate clinical trials for colorectal cancer (CRC) and basal cell carcinoma (BCC) following the readout of CHOPIN data[11] - The company plans to initiate Phase 2 trials in 2025 targeting liver-dominant metastatic patients[71] - The Phase 1b portion of the Chopin Trial showed an overall response rate (ORR) of 85.7% and a disease control rate (DCR) of 100%[67] - The FOCUS trial reported an ORR of 36.3% and a median overall survival (OS) of 20.53 months[83] Treatment Efficacy and Patient Population - HEPZATO KIT received FDA approval on August 14, 2023, for treating patients with liver-dominant mUM[36] - Approximately 800 patients are potentially eligible for treatment with HEPZATO, which has no HLA genotype restrictions[37] - The one-year overall survival rate for patients with metastatic disease in the liver is only 13%, with median survival ranging from 4 to 15 months[29] - The FOCUS trial reported a median overall survival (OS) of 20.53 months for patients treated with HEPZATO, with a 1-year OS rate of 80%[85] - The median progression-free survival (PFS) for the same group was 9.03 months[85] - 55% of metastatic uveal melanoma (mUM) patients have no approved systemic treatment options, with most treated through multiple lines of therapy[32] Market Strategy and Expansion - The company is focused on expanding its market presence in Europe with the CHEMOSAT device launch[10] - The company aims to have 30 active commercial centers for HEPZATO by the end of 2025, with 22 sites currently accepting referrals[42] - 50% of the target sites for HEPZATO are either PPS exempt or NCI designated Cancer Centers, allowing for favorable reimbursement terms[50] Adverse Events and Safety - Adverse events related to the study treatment included thrombocytopenia (64%), leukopenia (44%), and anemia (33%) among 95 patients[89] - Grade 3 or 4 adverse reactions included leukopenia (34%) and anemia (33%)[89] Overall Objectives - The overall objective is to convert unresectable liver metastases into resectable ones, potentially improving survival rates[59] - The trial results suggest a potential for improved survival outcomes with HEPZATO compared to historical data[85] - The company is exploring further development of HEPZATO based on these promising results[85]

Core Viewpoint - Momentum investing focuses on following a stock's recent price trends, aiming to buy high and sell higher, with the expectation that established trends will continue [1] Company Overview: Delcath Systems, Inc. (DCTH) - DCTH currently holds a Momentum Style Score of B, indicating a positive momentum outlook [2] - The company has a Zacks Rank of 2 (Buy), suggesting strong potential for outperformance in the market [3] Performance Metrics - DCTH shares have increased by 4.17% over the past week, contrasting with a 1.24% decline in the Zacks Medical - Instruments industry [5] - Over the past quarter, DCTH shares have surged by 73.06%, and over the last year, they have gained 242.1%, while the S&P 500 has only moved 1.24% and 22.19% respectively [6] Trading Volume - The average 20-day trading volume for DCTH is 496,916 shares, which serves as a bullish indicator when combined with rising stock prices [7] Earnings Outlook - In the past two months, one earnings estimate for DCTH has increased, while none have decreased, raising the consensus estimate from -$0.80 to -$0.79 [9] - For the next fiscal year, one estimate has moved upwards with no downward revisions, indicating a positive trend in earnings expectations [9] Conclusion - Considering the positive momentum indicators and earnings outlook, DCTH is positioned as a 2 (Buy) stock with a Momentum Score of B, making it a potential candidate for near-term investment [11]

Core Viewpoint - Delcath Systems, Inc. (DCTH) has seen a significant stock price increase of 35.2% over the past four weeks, closing at $16.30, with analysts suggesting a potential upside to a mean price target of $21.80, indicating a further increase of 33.7% [1] Group 1: Price Targets and Analyst Consensus - The mean price target is based on five short-term estimates with a standard deviation of $1.92, where the lowest estimate of $20 suggests a 22.7% increase, and the highest estimate of $25 indicates a potential surge of 53.4% [2] - A low standard deviation among price targets reflects a strong agreement among analysts regarding the stock's price movement direction, which can serve as a starting point for further research [7] - Despite the consensus price target being a popular tool among investors, its reliability has been questioned, as empirical research shows that price targets often mislead rather than guide investors [5][6] Group 2: Earnings Estimates and Market Sentiment - Analysts have shown increasing optimism about DCTH's earnings prospects, as evidenced by a strong consensus in revising EPS estimates higher, which correlates with potential stock price increases [9] - The Zacks Consensus Estimate for the current year has risen by 3.5% over the past month, with no negative revisions, indicating positive sentiment [10] - DCTH holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, suggesting a strong potential upside [11]

Core Viewpoint - The article emphasizes the importance of confirming the sustainability of stock trends for successful short-term investing, highlighting the use of a specific screening strategy to identify stocks with strong fundamentals and positive price momentum [1][2]. Group 1: Stock Screening Strategy - The "Recent Price Strength" screen is designed to identify stocks with sufficient fundamental strength to maintain their recent uptrend, focusing on those trading in the upper portion of their 52-week high-low range, indicating bullishness [3]. - Delcath Systems, Inc. (DCTH) is highlighted as a strong candidate for trend investing, having increased by 43.1% over the past 12 weeks, reflecting investor confidence [4]. - A price increase of 30% over the last four weeks further confirms that the upward trend for DCTH is intact, with the stock currently trading at 93.8% of its 52-week high-low range, suggesting a potential breakout [5]. Group 2: 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, which are critical for near-term price movements [6]. - The Zacks Rank system has a proven track record, with Zacks Rank 1 stocks averaging an annual return of +25% since 1988, indicating the effectiveness of this ranking in identifying strong investment opportunities [7]. - The Average Broker Recommendation for DCTH is 1 (Strong Buy), reflecting high optimism from the brokerage community regarding the stock's near-term performance [7]. Group 3: Additional Investment Opportunities - Besides DCTH, there are several other stocks that meet the criteria of the "Recent Price Strength" screen, suggesting a broader range of investment opportunities for investors [8]. - The article encourages investors to explore over 45 Zacks Premium Screens tailored to different investing styles, which can help in identifying potential winning stocks [8].