Delcath Systems, Inc. (DCTH) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended September 2024. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released ...

Core Viewpoint - Delcath Systems' CHEMOSAT Hepatic Delivery System significantly improves melanoma-specific survival in patients with liver metastases from uveal melanoma when used as a first-line therapy, as demonstrated in a recent clinical study [1][4]. Company Overview - Delcath Systems specializes in interventional oncology, focusing on primary and metastatic liver cancers, with key products including HEPZATO KIT and CHEMOSAT Hepatic Delivery System [3]. - The CHEMOSAT device is regulated as a Class III medical device in Europe [3]. Clinical Study Findings - A retrospective study analyzed 167 patients diagnosed between 2005 and 2021, revealing that those receiving liver-directed therapies, including CHEMOSAT, had a median melanoma-specific survival (MSS) of 28 months, compared to 10 months for those on systemic therapies [2][5]. - The MSS improved to 30 months for patients treated between 2016 and 2021, indicating a growing effectiveness of liver-directed therapies [5]. Adoption and Market Trends - The use of CHEMOSAT increased from eight patients between 2005 and 2015 to 30 patients between 2016 and 2021, reflecting its rising preference for treating metastatic uveal melanoma [6]. - The global liver metastases treatment market is estimated to reach $2.66 billion by 2030, growing at a CAGR of 7.3% from an estimated $1.74 billion in 2024, driven by the rising prevalence of liver metastases and advancements in therapeutic options [7][8]. Stock Performance - Delcath Systems' shares have risen 164.4% year to date, outperforming the industry growth of 10% and the S&P 500's rise of 18.4% during the same period [10].

ALIOUI Mohammed Elamine/iStock via Getty Images Snowball Effect Just Getting Started When I wrote my bullish Delcath (NASDAQ:DCTH) article in November 2023 there was a lot of investor angst heading into the HEPZATO KIT launch in Q1 2024. It had received FDA approval in August 2023, but until sales start coming in, medical device stocks can move rapidly in either direction. Medical device stock volatility is the highest prior to approvals. Following approvals, it declines but is still elevated. The next step ...

Financial Data and Key Metrics Changes - Delcath reported total revenue of $7.8 million for Q2 2024, with $6.6 million from U.S. sales of HEPZATO and $1.2 million from European sales of CHEMOSAT, marking a significant increase compared to previous periods [5][19] - Gross margins were reported at 80% for the second quarter [19] - Cash and investments at the end of Q2 were $19.9 million, with cash used in operations approximately $4.5 million [19][20] Business Line Data and Key Metrics Changes - HEPZATO treatments averaged just under two treatments per month per center in Q2, with expectations of 1.5 to 2 treatments per center for the remainder of the year [10][11] - CHEMOSAT sales in Europe increased over 100% year-over-year, primarily driven by growth in Germany [12] - The company ended Q2 with seven active treatment centers, increasing to eight by the call date, with expectations to reach 12 by the end of Q3 and 20 by the end of 2024 [9][10] Market Data and Key Metrics Changes - In the Netherlands, approximately 40% of metastatic uveal melanoma patients are treated with CHEMOSAT, mainly as part of the ongoing CHOPIN trial [12] - The company is in the process of submitting for reimbursement in the U.K., with a review expected next year [12][13] Company Strategy and Development Direction - The company aims to activate additional treatment centers while managing investments carefully in the European market to maintain a breakeven basis [13] - Delcath is focusing on expanding the use of HEPZATO and CHEMOSAT in various treatment settings, including potential new clinical studies in colorectal and breast cancer [18] - The company plans to engage medical oncologists to integrate HEPZATO into treatment algorithms and explore combination therapies with immunotherapy [15][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving $10 million in quarterly U.S. revenue by Q4 2024, which is expected to trigger additional cash proceeds from warrant exercises [11][20] - The management noted that while the activation of treatment centers has been slower than anticipated, there are no systemic issues, and they expect all centers currently in process to activate by 2025 [6][9] Other Important Information - The company received New Technology Add-on Payment (NTAP) status for HEPZATO, effective October 1, 2024, which will help cover costs for a small percentage of Medicare patients requiring inpatient stays [11] - The CHOPIN trial is progressing, with 70 out of 76 patients enrolled, and results are expected to be presented in mid-2025 [17] Q&A Session Summary Question: What is the mean number of treatments for HEPZATO expected to progress over the next 12 to 24 months? - Management indicated that most patients are progressing to two, three, or more treatments, with expectations to match or exceed trial averages over time [22] Question: Can you comment on the average treatment per center metric excluding high-volume centers? - Management noted that while high-volume centers like Moffitt and Thomas Jefferson raise averages, most centers are expected to eventually perform at least two treatments per month [29] Question: What is the sustainability of gross margins and operating expenses? - Management stated that they are disciplined with operating expenses and do not anticipate needing a large sales force, which helps maintain margins [31] Question: How does the NTAP benefit adoption and procedure numbers? - Management believes NTAP will help hospitals with infrequent inpatient cases but does not expect it to significantly impact overall uptake [38] Question: What is the marketing strategy focus? - The current focus is on site activation, with plans to shift towards increasing patient awareness and access as more sites become operational [46] Question: What is the anticipated revenue run rate to achieve breakeven? - Management indicated that achieving around 60 to 80 kits per quarter would be necessary for breakeven or cash flow positive status, with hopes to reach this by Q1 2025 [43]

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, 2024 Or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 001-16133 ______________________ DELCATH SYSTEMS, INC. ( ...

Exhibit 99.1 Delcath Systems Reports Second Quarter 2024 Results and Business Highlights Company Reports $7.8 million in Quarterly Revenue Conference Call Today at 4:30pm Eastern Time QUEENSBURY, NY – August 5, 2024, Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today reported financial results and business highlights for the second quarter ended June 30, 2024. Recent Business Hig ...

Core Viewpoint - Delcath Systems, Inc. (DCTH) is identified as a promising momentum stock, currently holding a Zacks Rank of 2 (Buy) and a Momentum Style Score of B, indicating potential for near-term price increases [2][6]. Company Performance - DCTH shares have increased by 65.71% over the past quarter and 63.03% over the last year, significantly outperforming the S&P 500, which has moved 10% and 27.2% respectively during the same periods [4]. - The stock has shown a weekly increase of 1.38%, while the Zacks Medical - Instruments industry has risen by 3.36% in the same timeframe [10]. Earnings Outlook - Over the past two months, one earnings estimate for DCTH has moved higher, while none have moved lower, resulting in an increase in the consensus estimate from -$1.45 to -$1.31 for the full year [14]. - For the next fiscal year, one estimate has also moved upwards with no downward revisions during the same period [14]. Trading Volume - DCTH's average 20-day trading volume is 241,497 shares, which serves as a useful indicator for assessing price movements and market interest [13].

Core Viewpoint - Delcath Systems, Inc. (DCTH) has shown a significant price increase of 26.8% over the past four weeks, with analysts projecting a mean price target of $21, indicating a potential upside of 197.9% from the current price of $7.05 [1] Price Targets and Analyst Consensus - The average price target for DCTH ranges from a low of $16 to a high of $25, with a standard deviation of $3.74, suggesting a high degree of agreement among analysts [2] - The lowest estimate indicates a potential increase of 127%, while the most optimistic estimate points to a 254.6% upside [2] - A low standard deviation indicates strong consensus among analysts regarding the stock's price movement direction and magnitude [7] Earnings Estimates and Upside Potential - Analysts have shown increasing optimism about DCTH's earnings prospects, as evidenced by a positive trend in earnings estimate revisions [9] - The Zacks Consensus Estimate for the current year has increased by 13.8% over the past month, with no negative revisions [10] - DCTH holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [11]

Group 1 - Delcath Systems, Inc. (DCTH) shares have increased by 48.2% in the past four weeks, closing at $6.96, with a mean price target of $21 indicating a potential upside of 201.7% [1] - The mean estimate consists of four short-term price targets with a standard deviation of $3.74, where the lowest estimate of $16 suggests a 129.9% increase, and the highest estimate of $25 indicates a 259.2% surge [2] - Analysts show strong agreement in revising earnings estimates higher, which correlates with potential stock price movements, as the Zacks Consensus Estimate for the current year has risen by 13.8% over the past month [9][10] Group 2 - DCTH holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, suggesting a strong potential upside [11] - While price targets are often viewed skeptically due to their misleading nature, the direction implied by these targets can still serve as a useful guide for further research [8][5] - Analysts' tendency to set optimistic price targets may be influenced by business relationships, which can lead to inflated estimates [6]

Most of us have heard the dictum "the trend is your friend." And this is undeniably the key to success when it comes to short-term investing or trading. But it isn't easy to ensure the sustainability of a trend and profit from it. Often, the direction of a stock's price movement reverses quickly after taking a position in it, making investors incur a short-term capital loss. So, it's important to ensure that there are enough factors -- such as sound fundamentals, positive earnings estimate revisions, etc. - ...