CASI Pharmaceuticals, Inc. Q2 FY2020 earnings call

General Update

• Despite COVID-19 disruption, made progress in clinical and corporate; closed over $40M public offering, with management participating in financing.

EVOMELA Update

• First commercial product, proprietary melphalan; sales team of over 70; transitioned to new manufacturer reducing COGS; Q2 2020 revenue $2.6M, first half $6M; guidance of at least $10M for EVOMELA in 2020 second half.

Lead Programs

• CNCT19 (CAR-T 19): Phase 1 trial in B-cell non-Hodgkin lymphoma, enrolling patients; expected to complete Phase 1 by Q1 2021, pivotal trial in 2021, NDA in 2022; locally developed and manufactured, potential to address unmet need in China.
• CID-103 (anti-CD38): Fully human IgG1 anti-CD38 monoclonal antibody; preclinical data shows potential; IMPD filed with MHRA; Phase 1 study expected in Q1 2021 in UK and France.

Manufacturing Facility

• Plan to start construction of GMP manufacturing facility in Wuxi, China later this year to support clinical and commercial needs.

For the quarter ended June 30, 2020, CASI recognized $2.7 million in revenue, with $2.6 million attributed to EVOMELA sales. For the six months ended June 30, 2020, total EVOMELA revenue was $6 million. EVOMELA contributed approximately 96% of the second quarter revenue ($2.6M out of $2.7M) and 100% of the first half revenue.

EVOMELA

• Revenue guidance of at least $10M for 2020 second half.

CNCT19

• Phase 1 completion by Q1 2021, pivotal trial in 2021, NDA in 2022.

CID-103

• Phase 1 study expected in Q1 2021 in UK and France.

• COVID-19 impact on marketing efforts (limiting physician interactions).
• Manufacturer transition causing inventory shortages and COGS issues during Q2 2020.
• Uncertainties in clinical trial timelines and regulatory approvals for lead programs.

Q: What other preparation still need to be done for the CID-103 trial to start in early 2021?

A: IMPD has been approved, protocol amendment submitted to MHRA, and ongoing work with ethics committees and investigative sites for institutional review.

Q: Size of the pivotal study planned for CNCT19 and where does it come from?

A: Pivotal study expected to enroll approximately 35 to 40 evaluable patients, based on discussions with Chinese authorities.

Q: What is the reason for the impairment charge of approximately $1.5 million?

A: Impairment charge from divestiture of a few NDAs acquired last year, which were not material to the product line.

Q: Impact of COVID pandemic and manufacturer switch on second quarter?

A: COVID limited marketing efforts, especially in the first quarter; manufacturer switch caused inventory shortages as transition to new manufacturer took longer due to regulatory approvals, but now resolved with new manufacturer.

Q: Will data from CNCT19 be published before the pivotal study?

A: Data from institutional studies has been published, and Phase 1 results are likely to be shared next year.

Q: Preferences for licensing products and timeline?

A: Focus on hematology oncology, actively looking to license compounds, but deals are not always under immediate control and timing is uncertain.