Financial Performance - Total revenue for Q2 2024 was $7.8 million, a significant increase from $0.5 million in Q2 2023, representing a 1460% year-over-year growth[3] - The company reported a net loss of $13.7 million for Q2 2024, compared to a net loss of $7.2 million in Q2 2023[11] - Total liabilities as of June 30, 2024, were $29.7 million, an increase from $22.8 million at the end of 2023[9] Revenue Sources - Revenue breakdown includes $6.6 million from HEPZATO KIT sales in the U.S. and $1.2 million from CHEMOSAT sales in Europe[2] Expenses - Research and development expenses for Q2 2024 were $3.4 million, slightly down from $3.6 million in the same period last year[3] - Selling, general, and administrative expenses increased to $6.8 million in Q2 2024 from $4.8 million in Q2 2023, reflecting higher marketing and personnel costs[3] Operational Developments - Three new HEPZATO KIT treating centers were activated in the U.S. during Q2, bringing the total to eight active centers[2] - The company received New Technology Add-on Payment status for HEPZATO from CMS on August 1, 2024, which provides additional payments to hospitals for inpatient treatments[2] - The pivotal Phase 3 FOCUS study results for HEPZATO KIT were published in the Annals of Surgical Oncology, with a poster presentation scheduled for the upcoming ESMO conference in September 2024[2] Cash Position - The company ended Q2 2024 with cash and investments totaling $19.9 million[4]

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]

Core Viewpoint - The article emphasizes the importance of identifying and sustaining stock price trends for successful short-term investing, highlighting the need for strong fundamentals and positive earnings revisions to maintain momentum [1][2]. Group 1: Stock Performance - Delcath Systems, Inc. (DCTH) has shown a significant price increase of 67.7% over the past 12 weeks, indicating strong investor interest [4]. - The stock has also experienced a 49.5% price increase in the last four weeks, suggesting that the upward trend is still intact [5]. - DCTH is currently trading at 84% of its 52-week high-low range, indicating a potential breakout opportunity [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 [6]. - The stock has an Average Broker Recommendation of 1 (Strong Buy), reflecting high optimism from the brokerage community regarding its near-term price performance [7]. - The Zacks Rank system has a strong historical performance, with Rank 1 stocks averaging a +25% annual return since 1988 [7]. Group 3: Investment Strategy - The "Recent Price Strength" screen is a useful tool for investors to identify stocks like DCTH that are on an upward trend supported by strong fundamentals [3]. - In addition to DCTH, there are other stocks that meet the criteria of the "Recent Price Strength" screen, providing additional investment opportunities [8]. - The article suggests utilizing various Zacks Premium Screens tailored to different investing styles to enhance stock-picking strategies [8].

Financial Data and Key Metrics Changes - The company reported US revenue of $2 million from HEPZATO and $1.1 million from CHEMOSAT for Q1 2024, compared to $0.6 million for CHEMOSAT in the same period of 2023 [5][38] - Gross margins were 71% in the first quarter, with a non-recurring positive adjustment for standard cost reevaluation; without this adjustment, gross margins would have been approximately 60% [18][31] - Selling, general, and administrative expenses increased to $8.8 million from $4.2 million due to commercial launch preparations [39] Business Line Data and Key Metrics Changes - The company ended Q1 with four active treatment centers, which increased to six by the date of the call, with plans to reach 20 active centers by the end of 2024 [7][10] - The average treatments per center are projected to ramp from approximately one per month to two treatments per month by late Q4 2024 [30] Market Data and Key Metrics Changes - The company has engaged over 30 centers in various stages of becoming treating centers, indicating increased interest from healthcare providers [9] - The establishment of a permanent J-code effective April 1 has simplified the reimbursement process, leading to increased willingness from formulary committees to approve HEPZATO [29][55] Company Strategy and Development Direction - The company aims to build a strong commercial foundation in metastatic uveal melanoma to fund future clinical trials and expand its network of treating centers [33][34] - Plans to initiate clinical trials for HEPZATO in other tumor types within approximately a year [35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving $10 million in US quarterly revenue by the end of 2024, which would trigger a warrant exercise resulting in $25 million in proceeds [11][48] - The company believes its current financial resources are adequate to fund operations until it becomes cash flow positive [17] Other Important Information - Research and development expenses for Q1 2024 were $3.7 million, down from $4.7 million in Q1 2023, primarily due to decreased clinical trial activities [49] - The company ended Q1 with $27.2 million in cash investments, with cash used in operations approximately $9.6 million [47] Q&A Session Summary Question: What is the realized revenue per KIT sold? - The revenue for Q1 reflects 11 KITs sold, with pricing at $182.5 per KIT [40] Question: Is the growth in EU revenue sustainable? - The company expects continued growth in Germany, which has a consistent reimbursement form, but overall growth may vary [50] Question: What is the expected gross margin at peak revenue? - At peak revenue, gross margins are expected to approach close to 90% [51] Question: How is the patient profile of treated patients? - The company is seeing a mix of first-line and subsequent-line patients, with no trends of patients dropping off early [85][86] Question: What is the status of reimbursement and J-code effectiveness? - The J-code has simplified the reimbursement process, making it more predictable for hospitals [55] Question: How will future R&D be funded? - The company plans to fund R&D through its P&L, aiming to avoid excessive dilution from fundraising [73][74] Question: What is the current status of referrals from general oncologists? - The focus is on opening treatment sites and ensuring oncologists at those sites refer their patients for treatment [81]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the quarterly period ended March 31, 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. (Exact name of registrant as specified in its charter) ______________________ Delaware 06-1245881 WASHINGTON, D.C. 20549 _____________________ FORM 10-Q ______________________ x QUARTERLY REP ...

[Business Highlights and Operational Updates](index=1&type=section&id=Business%20Highlights%20and%20Operational%20Updates) Delcath achieved significant Q1 2024 progress in HEPZATO KIT's commercial launch, marked by strong revenue, increased active center guidance, and key operational milestones Q1 2024 Product Revenue | Product | Revenue (USD) | | :--- | :--- | | HEPZATO KIT | $2.0 million+ | | CHEMOSAT | $1.1 million | - Updated U.S. center activation guidance, increasing the target from **15 to 20 active centers** by the end of 2024[2](index=2&type=chunk) - Raised **$7.0 million** in a private placement from existing investors, senior executives, and board members[2](index=2&type=chunk) - Received a permanent, product-specific J-code (J9248) and transitional pass-through payment status for HEPZATO KIT from CMS, effective April 1, 2024[2](index=2&type=chunk) - Appointed Martha S. Rook, Ph.D, as Chief Operating Officer[2](index=2&type=chunk) - Extended the supply agreement for melphalan hydrochloride with Synerx Pharma, LLC and Mylan Teoranta to December 31, 2028[2](index=2&type=chunk) [First Quarter 2024 Financial Performance](index=2&type=section&id=First%20Quarter%202024%20Financial%20Performance) Delcath's Q1 2024 revenue increased to $3.1 million, but operating loss widened to $10.3 million due to higher SG&A, ending the quarter with $27.2 million in cash Q1 2024 Key Financial Metrics (YoY Comparison) | Metric | Q1 2024 (USD) | Q1 2023 (USD) | Change | | :--- | :--- | :--- | :--- | | Total Revenue | $3.1 million | $0.6 million | +417% | | R&D Expenses | $3.7 million | $4.6 million | -19.6% | | SG&A Expenses | $8.8 million | $4.2 million | +110% | | Operating Loss | ($10.3 million) | ($8.3 million) | +24% | | Cash Position | $27.2 million | N/A | N/A | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q1 2024 total revenues surged to $3.1 million, increasing gross profit, but higher SG&A expenses led to a widened operating loss of $10.3 million and a net loss of $11.1 million Q1 2024 Statement of Operations (in thousands, except per share data) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Total Revenues | $3,139 | $597 | | Gross Profit | $2,236 | $416 | | Research and development expenses | $3,700 | $4,576 | | Selling, general and administrative expenses | $8,814 | $4,165 | | Operating loss | $(10,278) | $(8,325) | | Net loss | $(11,111) | $(9,000) | | Basic and diluted loss per common share | $(0.45) | $(0.77) | [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2024, Delcath held $27.2 million in cash and investments, with total assets at $36.1 million and total liabilities decreasing to $21.5 million Balance Sheet Highlights (in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $11,760 | $12,646 | | Short-term investments | $15,360 | $19,808 | | Total current assets | $33,646 | $37,158 | | Total assets | $36,099 | $38,613 | | Total current liabilities | $13,341 | $16,448 | | Total liabilities | $21,479 | $22,836 | | Total stockholders' equity | $14,620 | $15,777 | [Company Information and Forward-Looking Statements](index=2&type=section&id=Company%20Information%20and%20Forward-Looking%20Statements) Delcath Systems is an interventional oncology company focused on liver cancer treatment with HEPZATO KIT in the U.S. and CHEMOSAT in Europe, providing standard forward-looking statement disclaimers - Delcath is an interventional oncology company focused on treating primary and metastatic liver cancers[6](index=6&type=chunk) - HEPZATO KIT is approved in the U.S. for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than **50%** of the liver and limited or no extrahepatic disease[6](index=6&type=chunk) - In Europe, the device component is regulated as a Class III medical device and sold under the name CHEMOSAT[7](index=7&type=chunk) - The press release contains forward-looking statements subject to risks and uncertainties, including commercialization, supply chain management, and reimbursement[8](index=8&type=chunk)

Conference Call Today at 8:30 am Eastern Time QUEENSBURY, N.Y., May 14, 2024 /PRNewswire/ -- 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 first quarter ended March 31, 2024. Recent Business Highlights During and since the first quarter, Delcath: "We continue to make steady progress in the training and activation of ...

Significantly Higher Overall Response Rate vs Meta-analysis of Historical Controls (36.3% vs. 5.5%) Other Efficacy Endpoints Include a 73.6% Disease Control Rate with a 7.7% Complete Response Rate NEW YORK, May 6, 2024 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced the publication of results from the pivotal Phase 3 FOCUS study of HEPZATO KIT (melphalan/Hepatic Delivery System) ...