CASI Pharmaceuticals, Inc. Q1 FY2021 earnings call

• EVOMELA revenues continue to increase with costs going down, and the commercial and medical marketing team is preparing for the launch of CNCT19.
• CB-5339, a VCP/p97 inhibitor from Cleave Therapeutics, was licensed for the Greater China market. It's an oral small molecule being evaluated in a Phase I trial for AML and MDS.
• BI-1206, an anti-Fc gamma RIIb antibody, has a novel mode of action and is in clinical trials. CASI is responsible for its development and commercialization in Greater China.
• CID-103, an anti-CD38 monoclonal antibody, has preclinical data showing enhanced activity and a better safety profile. Phase I study initiated in France.
• Thiotepa is progressing well, with plans to submit IND applications for 2 indications to NNPA in 2021.
• Cash and cash equivalents totaled approximately $68.1 million as of March 31, 2021, with sufficient resources to fund operations beyond 2022. The company uses a venture approach in business development, investing in partners to deepen collaborations.

EVOMELA, the first commercial drug, recorded revenue of $5.7 million in the first quarter, a 69% increase from the year-ago quarter. EVOMELA contributes to revenues, and costs were reduced due to transitioning to a lower-cost manufacturer. The revenue from EVOMELA is targeting more than 50% growth over 2020.

• Target to achieve more than 50% revenue growth for EVOMELA in 2021 compared to 2020.
• CASI has sufficient cash to fund operations beyond 2022.
• Plans to potentially double the sales force in preparation for the launch of CNCT19.

Q: Even though EVOMELA continues to grow at a good pace, what's the focus for accelerated growth?

A: Expanding reach to more hospitals and educating treating physicians about the utility of the drug, as there's a need to convert more KOLs to the new treatment regimen.

Q: Comment on seasonalities for EVOMELA in the Chinese market and the CNCT19 program.

A: First quarter in China is typically low due to Chinese New Year. For CNCT19, CASI believes it will be the first domestic CAR-T 19 to complete pivotal trials and submit NDA, with a strong sales and marketing team in place from EVOMELA.

Q: Size of current sales force and plans for CNCT19 launch?

A: Current sales force is under 100, and they plan to potentially double it in preparation for CNCT19 launch.

Q: Thoughts on EVOMELA market demand and timeline to reach peak revenue, and CNCT19 clinical study timeline and manufacturing?

A: Peak revenue for EVOMELA may be in 3-4 years. CNCT19's clinical data may be published around the time of NDA filing. Juventas has a built GMP facility in Tianjin that can manufacture for at least 2,000 patients, already in use for Phase II trials.