CASI Pharmaceuticals, Inc. Q3 FY2021 earnings call

Key Program Updates - EVOMELA: Revenues of $8.1 million in Q3 2021, 92% increase y-o-y. Over 4,000 patients treated in the first 9 months of 2021, with goal to treat over 10,000 patients annually. Post-marketing study for EVOMELA in China completed accrual. - CAR-T 19: Partner Juventas making progress with CNCT19 trials. Juventas completed Series C financing raising ~$63 million. - CID-103: Phase I trial in patients with relapsed or refractory multiple myeloma ongoing. - BI-1206: Positive Phase I results with objective response rate of 50% in some patients. CASI plans to develop BI-1206 in Greater China. - CB-5339: Acquired from Cleave Therapeutics, in Phase I clinical trial for AML and MDS. - Financials: Cash and cash equivalents at $53.1 million as of Sept 30, 2021; sufficient resources to fund operations beyond 2022.

EVOMELA was the key product segment. In the third quarter of 2021, EVOMELA generated revenue of $8.1 million, a 92% increase from the same period in 2020. Cost of revenue for EVOMELA in Q3 2021 was $3.4 million, with royalty payments being a component. The commercial team in China, which has over 100 hematology/oncology sales and medical marketing specialists, is expanding in preparation for future product launches like CNCT19.

Guidance - CASI remains confident in full-year 2021 revenue growth exceeding 80% over 2020. - Company has sufficient cash to fund operations beyond 2022, with focus on building shareholder value.

Risks - Drug and cell therapy pricing in China is a significant issue, potentially affecting product adoption. - Forward-looking statements subject to numerous risks and uncertainties that could cause actual results to differ materially from projections.

Q: Leland Gershell asked about the commercial organization in China expanding with EVOMELA sales and future BD deals.

A: Wei-Wu He responded that the commercial team is expanding aggressively for CAR-T 19 launch, with EVOMELA revenue growth helping fund expansion. Regarding BD, CASI is picky about fit with commercial strategy, looking for synergistic assets.

Q: Sean Lee inquired about EVOMELA patient numbers in 2021 and CAR-T enrollment, and BI-1206 next steps.

A: Wei-Wu He said ~4,000 patients treated in first 9 months of 2021 with goal to treat over 10,000 annually; Juventas CAR-T enrollment on track. Alex Zukiwski mentioned BI-1206 will proceed with BioInvent after FDA Phase II meeting and Chinese PK/PD study.

Q: Justin Zelin asked about EVOMELA growth trends, CAR-T pricing in China.

A: Wei-Wu He stated the main bottleneck for EVOMELA is transplant units in hospitals; mentioned high pricing of current CAR-T therapies in China and expectation CASI's CNCT19 will be priced significantly lower.