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 ...

Exhibit 99.1 Delcath Systems Reports First Quarter 2024 Results and Business Highlights Conference Call Today at 8:30am Eastern Time QUEENSBURY – May 14, 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 first quarter ended March 31, 2024. Recent Business Highlights During and since the first quarter, Delcath: "We ...

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) ...

Shares of Delcath Systems, Inc. (DCTH) have gained 18.2% over the past four weeks to close the last trading session at $5.51, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $19 indicates a potential upside of 244.8%.The mean estimate comprises three short-term price targets with a standard deviation of $2.65. While the lowest estimate of $16 indicates a 190.4% increase from the ...

Delcath Systems, Inc. (DCTH) closed the last trading session at $5.03, gaining 26.1% 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 $19 indicates a 277.7% upside potential.The average comprises three short-term price targets ranging from a low of $16 to a high of $21, with a standard deviation of $2.65. While the lowest estimate indicates an increase of 218.1% from the current pri ...

NEW YORK, April 4, 2024 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH) (the "Company" or "Delcath"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announces that the Company granted an equity award, previously approved by the Company's Compensation Committee, as a material inducement to the employment of one individual whose employment commenced in March 2024. The grant totaled the right to purchase an aggregate of 30,000 shares of the Comp ...

Investors might want to bet on Delcath Systems, Inc. (DCTH) , as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.The power of a c ...

Financial Data and Key Metrics Changes - The company ended Q4 with $32.5 million in cash and investments, with cash used in operations approximately $8.1 million for the fourth quarter [31] - Revenue from sales of CHEMOSAT was $0.5 million for the three months ended December 31, 2023, compared to $0.6 million for the same period in 2022 [32] - Selling, general and administrative expenses increased to $7 million from $3.8 million due to activities preparing for the commercial launch [51] Business Line Data and Key Metrics Changes - The company expects to have 4 active sites treating commercial patients by the end of Q1 2024, including Moffitt Cancer Center, Stanford University Cancer Center, and Thomas Jefferson University [6] - Average treatments per site are expected to increase from approximately 1 per month early in Q2 to a run rate of 2 treatments per month by late Q4 [7] Market Data and Key Metrics Changes - The company is working with over 20 leading cancer centers across the U.S. that have expressed interest in incorporating HEPZATO KIT into their practices [41] - The establishment of a permanent J-code for HEPZATO is expected to simplify the reimbursement process and increase the pace of facilities conducting their first commercial treatment [8][20] Company Strategy and Development Direction - The company is increasing its site activation guidance from 15 to 20 active sites by the end of 2024, with a pacing of 10 active sites by the end of Q2 and 15 by the end of Q3 [18] - The company plans to pursue additional indications for HEPZATO, targeting unmet medical needs in liver cancers [30][48] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving $10 million in quarterly revenue no later than Q4 2024, driven by the ramp-up of active treatment sites [31][32] - The company believes that the future has never been brighter, with significant growth opportunities in treating metastatic uveal melanoma and other liver cancers [30][49] Other Important Information - The company closed a $7 million private placement to ensure sufficient cash for operations until achieving $10 million in quarterly revenue [50] - The company has trained over 90 healthcare professionals across approximately 20 institutions in the U.S. [21] Q&A Session Summary Question: What therapies are patients being treated with and what is the interest in combination therapies? - Management indicated that patients have varied treatment histories, with some having prior systemic or liver-directed treatments, and there is interest in combination therapies with ongoing trials [54][57] Question: What is the base case outlook for the company's finances going forward? - The base case is to achieve cash flow positivity and fund new development from cash flows without additional financing, assuming the stock performs well [58] Question: How many patients have been treated commercially so far and what are the trends? - Approximately 80% of the first quarter's revenue is expected to come from Moffitt, with patients returning for repeat treatments [61][74] Question: What percentage of the overall market do you expect to cover by the end of this year? - It is estimated that over 75% of patients who have one or more referrals at the first 20 sites will be covered [67][80] Question: What reimbursement processes have been encountered so far? - The company faced challenges in obtaining reimbursement codes initially but managed to activate four sites using a miscellaneous code before the J-code became effective [68]