CASI PHARMACEUTICALS ANNOUNCES THIRD QUARTER 2022 FINANCIAL RESULTS

On November 14, 2022 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported financial results for the third quarter of 2022 (Press release, CASI Pharmaceuticals, NOV 14, 2022, View Source [SID1234624057]).

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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "We are pleased to report $10.2 million in EVOMELA sales revenue for the third quarter of 2022. This is a 26% of increase compared to the same period last year. Our teams in both China and US delivered strong performance despite the continued COVID lockdown in several major cities in China. Since the third quarter, the COVID-19 pandemic has gradually spread nationwide in China, with many small to medium-sized cities upgrading their control measures. The implementation of these enhanced pandemic control measures is expected to adversely impact our sales activities for the remainder of the year."

Dr. He continued, "Advancement, development, and commercialization of the portfolio remains our strategic focus. Through our partner Juventas, the CNCT-19 New Drug Application (NDA) submission to the National Medical Products Administration (NMPA) is on track, and we are in preparation for the anticipated CNCT-19 launch in China. As we continue the development of the regulatory framework for BI-1206 in China, we were pleased with the recent dosing of the first patient in the BI-1206 phase I trial in China. We expect CB-5339 to receive Clinical Trial Application approval from the NMPA in early 2023; Meanwhile, our CID-103’s Phase I study continues. We plan to build on the momentum to drive our portfolio forward by executing on several milestones in the quarters ahead."

Third Quarter 2022 Financial Highlights

Revenues consist primarily of product sales of EVOMELA. Revenue was $10.2 million for the three months ended September 30, 2022, compared to $8.1 million for the three months ended September 30, 2021.
Costs of revenues consist primarily of the cost of inventories of EVOMELA and sales-based royalties related to the sale of EVOMELA. Costs of revenues were $4.2 million for the three months ended September 30, 2022, compared to $3.4 million for the three months ended September 30, 2021.
Research and development expenses for the three months ended September 30, 2022, were $3.9 million, compared with $2.9 million for the three months ended September 30, 2021. The increase of research and development expenses for the three months periods was mainly due to expense incurred for BI-1206 and CID-103.
General and administrative expenses for the three months ended September 30, 2022, were $4.8 million, compared with $5.3 million for the three months ended September 30, 2021.
Selling and marketing expenses for the three months ended September 30, 2022, were $3.6 million, compared with $3.4 million for the three months ended September 30, 2021.
Acquired in-process R&D expenses for the three months ended September 30, 2022 and 2021, were both nil.
As of September 30, 2022, CASI had cash and cash equivalents of $29.2 million.