Financial Data and Key Metrics Changes - Total revenue for Q3 2024 was reported at $11.2 million, with $10 million from HEPZATO in the US and $1.2 million from CHEMOSAT in Europe, marking a significant increase compared to previous periods [8][33] - Revenue from HEPZATO grew significantly, while CHEMOSAT revenue increased over 100% year-on-year, indicating strong growth momentum [15][33] - Gross margins were reported at 85% for the third quarter [33] Business Line Data and Key Metrics Changes - HEPZATO revenue was $10 million, while CHEMOSAT revenue was $1.2 million for the three months ended September 30, 2024, compared to $0.4 million for CHEMOSAT during the same period in 2023 [33] - The average treatment rate post-activation was just under two treatments per month in Q3, with expectations for this rate to remain flat as new centers are added [13][15] Market Data and Key Metrics Changes - The company activated 11 centers by the end of Q3, with an additional center activated in October, bringing the total to 12, and aims to reach 15 treating centers by year-end [10][12] - The goal for 2025 is to have 30 centers operational by the end of the year [12] Company Strategy and Development Direction - The company is focusing on expanding its center activations and treatment rates, with a strategic goal of increasing the number of treating centers significantly [12][31] - Plans to initiate two phase II randomized clinical trials for liver dominant metastatic colorectal cancer and metastatic breast cancer were announced, indicating a strategic expansion into new indications [29][30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's future, citing a strong balance sheet and expected revenue growth, with a cash burn of only $3.6 million in Q3 [31][32] - The company is on the cusp of being cash flow break-even, with adequate resources to fund further expansion of both commercial and clinical development activities [31][32] Other Important Information - The company has no outstanding debt obligations as of the end of Q3, following the maturity of loans [36][37] - The company is actively engaging with medical oncologists to integrate HEPZATO into treatment algorithms for metastatic uveal melanoma and other cancers [25][28] Q&A Session Summary Question: Will the holiday season affect treatment days? - Management indicated that there may be fewer treatment days due to the holiday season, but this is expected to be a temporary shift rather than lost business [40][42] Question: What is the expected increase in R&D spend for upcoming trials? - R&D expenses are expected to remain flat in Q4, with a projected range of $35 million to $40 million for the full year, including new indications [43][89] Question: How is the company approaching medical oncologists for referrals? - The company is actively engaging medical oncologists and has seen a fair number of referrals, although it acknowledges the need for further development in this area [66][70] Question: What data is expected from the CHOPIN trial? - The CHOPIN trial is fully enrolled, and data readouts are expected mid-next year, with results to be presented in the second half of the year [63][64]
Delcath(DCTH) - 2024 Q3 - Earnings Call Transcript