CASI(US:CASI)2022-08-12 16:28Financial Data and Key Metrics Changes - Revenue for the second quarter of 2022 was $8.6 million, a 19% increase compared to $7.2 million in the same period last year [20] - Revenue from EVOMELA sales increased by 19% year-over-year despite challenges from COVID-related lockdowns [4][20] - Cash and cash equivalents at the end of the quarter stood at $18.9 million [20] Business Line Data and Key Metrics Changes - EVOMELA generated $8.6 million in revenue for Q2 2022, with a notable increase from the previous year [9][20] - The company entered into a sub-license agreement with Precision Autoimmune Therapeutics, which includes an upfront payment of $10 million [7][20] Market Data and Key Metrics Changes - COVID-related lockdowns in major cities in China, particularly Shanghai, impacted sales and access to hospitals, affecting revenue generation [4][25] - The company anticipates that the revenue will recover as restrictions ease, although the unpredictability of COVID-19 remains a concern [25][26] Company Strategy and Development Direction - The strategic focus for 2022 is to advance the development and commercialization of the product portfolio, including the anticipated launch of CNCT19 in China [5] - The company aims to maintain its focus on the hematology-oncology market while exploring opportunities in autoimmune diseases through partnerships [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the recovery of revenue despite the challenges posed by COVID-19, highlighting the resilience of the sales and marketing team [25][26] - The company is well-financed into 2023, with a combination of cash reserves and a new loan agreement [20][30] Other Important Information - A ten-to-one reverse stock split was executed to meet Nasdaq listing requirements, resulting in approximately 13.6 million shares outstanding [6] - The company is preparing for the anticipated NDA filing for CNCT19 in the second half of 2022, with expected approval in 2023 [34] Q&A Session Summary Question: Challenges due to COVID and resolution timeline - Management acknowledged significant revenue impact from COVID lockdowns in Shanghai but noted recovery in some areas [25][26] Question: Details on the Precision Autoimmune Therapeutics deal - The partnership was chosen due to the potential of CD38 in treating autoimmune diseases and the financial backing from local venture capital [28][30] Question: Timing for CNCT19 NDRL listing and competition - The NDA for CNCT19 is expected to be filed in 2022, with approval likely in 2023; competition from other CAR-T therapies is acknowledged but the company believes in its competitive pricing [34][35] Question: Additional steps before CNCT19 launch - Sufficient manufacturing capacity is in place for the first year, with no anticipated issues at approval [39] Question: Timeline for BI-1206 and Thiotepa development - Submission for Thiotepa is expected within four to six months, while BI-1206 is moving forward with plans to initiate patient dosing soon [41]