CASI Pharmaceuticals, Inc. Q2 FY2021 earnings call

• EVOMELA revenue in Q2 was $7.1 million, a 173% year-over-year increase. Full-year 2021 revenue growth guidance revised to exceed 80% over 2020.
• Commercial and medical marketing team preparing for CNCT19 launch. CNCT19 is a CAR-T 19 program with Juventus, being developed and manufactured locally in China.
• BI-1206, acquired in October 2020, is a novel anti-Fc gamma RIIb antibody with ongoing trials, and CASI intends to file an R&D for it with NMPA in 2021.
• CB-5339, acquired in March 2021, is a VCP/p97 inhibitor in Phase I clinical trial, with CASI planning to file an R&D with NMPA in 2022.
• CID-103, an anti-CD38 monoclonal antibody, had its first patient in Phase I study in June.
• Thiotepa asset continuing to progress, with expected regulatory applications to NMPA in 2021.
• Cash and cash equivalents at $60.4 million as of June 30, 2021, sufficient to fund operations beyond 2022.

EVOMELA generated revenue of $7.1 million in the second quarter, a 173% increase from the year-ago quarter. For the full year 2021, based on current trends, CASI is revising its guidance for 2021 revenue growth to exceed 80% over 2020. EVOMELA is approved in China for high-dose conditioning prior to hemoprotein stem cell transplant in multiple myeloma patients and is the only injectable melphalan commercially available in China.

• Revised 2021 revenue growth to exceed 80% over 2020 based on current trends.
• Cash and cash equivalents of $60.4 million as of June 30, 2021, with sufficient resources to fund operations beyond 2022.

Q: Any pull-through from Q1 seasonality with Q2 results and expectations for second half growth?

A: Expect quarter-to-quarter growth, with EVOMELA's revenue growth expected to be more predictable moving forward as manufacturing stabilizes.

Q: On CID-103, number of sites and accrual?

A: Currently 3 sites active in France and U.K., expanding to 2-3 more in a year, accrual going as predicted with a lull expected in August due to European vacation season.

Q: Context on commercial market evolution for cell therapy in China and CNCT19's place?

A: First CAR-T 19 approval in China, CNCT19 is domestically produced with lower cost of goods sold, expected to capture significant market share with pre-launch preparations including hospital detailing and commercial team building.

Q: Next steps in CNCT19 regulatory process and commercial preparation?

A: Complete Phase II patient data, Juventus to submit NDA to NMPA, with preparative work including hospital connections and commercial team building underway. Manufacturing facility already certified by NMPA with capacity for over 2,000 patients.

Q: BI-1206 clinical plans and timeline?

A: Plan to piggyback on BioInvent's global trial, submit IND in China for relapsed and refractory non-Hodgkin's lymphoma in combination with rituximab before end of 2021.

Q: Thoughts on EVOMELA Q3/Q4 revenue flattening and market penetration?

A: EVOMELA has underestimated market potential, guidance of 80% growth implies strong performance, with commercial team proud of achievements, and market penetration limited by transplant center capacity and reeducation of physicians on autologous transplant benefits.