Financial Data and Key Metrics Changes - The company reported a combined revenue of $19,800,000 for Hebsado and ChemoSATs in Q1 2025, with Hebsado sales in the U.S. contributing $18,000,000 and ChemoSATs in Europe adding $1,800,000, compared to $2,000,000 and $1,100,000 respectively in Q1 2024 [7][16] - Gross margins improved to 86% in Q1 2025 from 71% in the same period last year [16] - Net income for Q1 2025 was $1,100,000, a significant turnaround from a net loss of $11,100,000 in Q1 2024 [17] - Positive adjusted EBITDA was reported at $7,600,000 compared to an adjusted EBITDA loss of $7,300,000 in Q1 2024 [17] - The company ended the quarter with approximately $59,000,000 in cash and investments and no debt [8][17] Business Line Data and Key Metrics Changes - The U.S. market for Hebsado and ChemoSATs showed strong growth, with a focus on expanding treatment centers, increasing from 17 to 19 active centers [8][9] - The average treatments per center per month were approximately two in Q1, with expectations to remain just under two for the remainder of the year [10][28] Market Data and Key Metrics Changes - The European market for ChemoSATs grew by 29% over the prior quarter to $1,800,000, although it is not expected to be a significant revenue contributor in the short to medium term due to reimbursement pricing challenges [11] - The company is focusing on generating clinical data from European sites, which have over a decade of experience with ChemoSATs [11][44] Company Strategy and Development Direction - The company aims to expand its active treatment centers to 30 by year-end, with a current pace of opening three to five centers per quarter [9][10] - The strategic focus includes leveraging cash from operations to support research and development initiatives for broader patient populations suffering from liver cancer [8][15] - The company is pursuing additional indications for Hepciddo, including metastatic colorectal and breast cancer, with ongoing clinical trials [12][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a more even distribution of center activations throughout the year, rather than a concentration in the second half [25] - The company anticipates that the ongoing engagement with oncologists and interventional radiologists will drive demand for treatments [15] - Management acknowledged the competitive landscape but emphasized the collaborative nature of information sharing among treatment centers [38] Other Important Information - The company has implemented a patient access program to assist with copay costs and connect patients with treatment centers [10][53] - The company is managing its European operations on a breakeven basis while focusing on generating clinical data [44] Q&A Session Summary Question: Update on center activations - Management indicated that the pace of center activations may be more even throughout the year than previously anticipated, with potential for two to three additional centers in Q2 [25][26] Question: R&D expenses and EBITDA expectations - R&D expenses are expected to increase significantly, with total operating expenses projected to rise by 60% over 2024, while maintaining positive EBITDA for the year [30][31] Question: Frequency of patient treatments - The average frequency of treatments for patients is expected to remain around 4.1, which is a key driver for overall revenue [36] Question: European market growth and reimbursement - Management noted that while European revenues are increasing, reimbursement challenges remain, and they are focusing on generating clinical data before investing more resources [40][44] Question: Companion diagnostics and potential acquisitions - The company is open to exploring companion diagnostics or synergistic products but has not found suitable opportunities yet [70][72]

Financial Data and Key Metrics Changes - The company reported a combined revenue of $19.8 million for Q1 2025, with Hebsado sales in the U.S. contributing $18 million and ChemoSAT sales in Europe adding $1.8 million, compared to $2 million and $1.1 million respectively in Q1 2024 [5][15] - Gross margins improved to 86% in Q1 2025 from 71% in the same period last year [15] - Net income for Q1 2025 was $1.1 million, a significant turnaround from a net loss of $11.1 million in Q1 2024 [16] - Positive adjusted EBITDA for Q1 2025 was $7.6 million, compared to an adjusted EBITDA loss of $7.3 million in Q1 2024 [16] - The company ended the quarter with approximately $59 million in cash and investments, and positive operating cash flow of $2.2 million [16] Business Line Data and Key Metrics Changes - The company activated 19 treatment centers in the U.S. by the end of Q1 2025, with plans to reach 30 active centers by year-end [6][7] - Average treatments per center were approximately two per month in Q1, with expectations to remain just under two for the remainder of the year [8][27] Market Data and Key Metrics Changes - The European market for ChemoSAT experienced a 29% growth over the prior quarter, reaching $1.8 million, although it is not expected to be a significant revenue contributor in the short to medium term [9] - The company is focusing on expanding its presence in the U.S. market while managing reimbursement challenges in Europe [9][40] Company Strategy and Development Direction - The company aims to leverage cash from operations to support research and development initiatives for Hebsado beyond metastatic uveal melanoma patients [6] - The strategy includes expanding treatment centers and enhancing access for patients through the Hepcido KidAccess 360 platform [8] - The company is pursuing additional clinical trials for liver-dominant metastatic colorectal and breast cancer, with FDA clearance received for both trials [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the goal of 30 active centers by year-end, with a balanced approach to center activations throughout the year [22][24] - The company anticipates that the average monthly treatment per site will stabilize just under two for the remainder of the year due to the pace of new center activations [27] - Management highlighted the importance of clinical demand and engagement with oncologists and interventional radiologists in driving revenue growth [13] Other Important Information - The company has no outstanding debt obligations and has successfully raised $16.2 million through the exercise of Series F warrants [16][17] - The company is managing its European operations on a breakeven basis while focusing on generating clinical data [43] Q&A Session Summary Question: Update on center activations and expectations for Q2 - Management indicated that center activations may be more evenly distributed throughout the year than previously anticipated, with potential for two to three additional centers in Q2 [20][24] Question: Treatment frequency and center performance - Average treatment frequency is expected to stabilize around 4.1 treatments per patient, with a mix of organic and referred patients contributing to center performance [35][86] Question: R&D expenses and EBITDA expectations - R&D expenses are expected to increase significantly, with EBITDA margins projected to remain positive throughout the year despite rising operational costs [29][30] Question: European market growth and reimbursement - Management noted that while the European market is growing, reimbursement challenges remain, and additional resources will be allocated once reimbursement is secured [39][42] Question: Companion diagnostics and potential acquisitions - The company is open to exploring companion diagnostics or synergistic products but has not identified any suitable opportunities at this time [70][72]

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 Delaware 06-1245881 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 566 Queensbury Avenue Queensbury, NY 12804 (Address of principal executive offices) (518) 743-8892 (Registrant's telephone number, including area code) For t ...

Core Viewpoint - Delcath Systems, Inc. (DCTH) shows potential for significant upside, with a mean price target of $22.60 indicating a 58.5% increase from the current price of $14.26 [1] Price Targets and Analyst Consensus - The average price target for DCTH ranges from a low of $21 to a high of $25, with a standard deviation of $1.82, suggesting a relatively tight clustering of estimates [2] - The lowest estimate indicates a potential increase of 47.3%, while the highest suggests a 75.3% upside [2] - Analysts' price targets should be approached with caution, as they may not reliably predict actual stock price movements [3][7] Earnings Estimates and Analyst Agreement - Strong agreement among analysts regarding DCTH's ability to report better earnings than previously predicted supports the view of potential upside [4] - A positive trend in earnings estimate revisions has been shown to correlate with stock price movements, indicating a potential for growth [11] - Over the last 30 days, one earnings estimate for DCTH has increased, leading to a Zacks Consensus Estimate rise of 134.2% [12] Zacks Rank and Investment Potential - DCTH holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors [13] - The strong externally-audited track record of DCTH further supports its potential for near-term upside [13]

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]

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 ...

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]

Delcath Systems, Inc. (NASDAQ:DCTH) Q4 2024 Earnings Conference Call March 6, 2025 8:30 AM ET Company Participants David Hoffman - General Counsel, Corporate Secretary & Chief Compliance Officer Gerard Michel - CEO Sandra Pennell - SVP, Finance Kevin Muir - General Manager, Interventional Oncology Vojislav Vukovic - Chief Medical Officer Conference Call Participants John Newman - Canaccord Genuity Corp Marie Thibault - BTIG Sudan Loganathan - Stephens Bill Maurer - ClearStreet Yale Jen - Laidlaw & Company C ...

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].