CASI Pharmaceuticals announces second quarter 2020 financial results

CASI Pharmaceuticals, Inc., a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported financial results and business highlights for the second quarter of 2020.

Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, “One of the positive developments with respect to EVOMELA this quarter was the successful transition to a new manufacturer for the commercial supply in China. This was a key accomplishment as we expect it to significantly reduce our cost of revenue. Despite the impact of COVID-19 and manufacturer change in the second quarter, we expect EVOMELA revenue to reach at least $10 million for the full year 2020.  We also expect significant improvement in our margins for EVOMELA for the second half of 2020.”

Dr. He continued, “The current Phase 1 trials for CNCT19, a CD19 CAR-T therapy, conducted by our development partner, Juventas, are well underway. Juventas expects to complete trials in B-NHL and B-ALL and initiate registration trials in the first quarter 2021, followed by NDA filing in China in early 2022. As Juventas’ exclusive commercial partner, we expect that with a locally developed and manufactured CD19 CAR-T, we will be able to offer a much lower price point than imported therapies and thus be able to make this important cell-based therapy available to significantly more patients in China.”

“With regard to CID-103, our anti-CD38 monoclonal antibody, we recently submitted our IMPD application with MHRA, the British health authority, to initiate our Phase 1 clinical study in the UK. Clinical centers in the EU continue to be impacted by COVID-19; however, we expect to initiate our study in the first quarter 2021 assuming the centers open back up for clinical trial activities.”

“And finally, we were pleased to report our recent closing of an underwritten public offering for gross proceeds of $43.7 million. This successful financing attracted a number of new, fundamentally-driven, long-term oriented, healthcare-dedicated investors to the CASI story, as well as continued investment by our management. We look forward to continuing to expand our U.S. investor base, and importantly, positioning CASI to accelerate long-term value creation for our shareholders.”

Second Quarter 2020 Financial Results

• Revenues consisted primarily of product sales of EVOMELA that launched in August of 2019. Revenues were $2.7 million for the three months ended June 30, 2020. The decrease in the second quarter revenue figures, compared to those in the first quarter was primarily due to a manufacturer change and the effects caused by the global COVID-19 pandemic. We have since received shipment of EVOMELA from the new, lower-cost supplier and expect the product to be released into our distribution chain this month. We expect our revenue from EVOMELA will resume its original projected course in the second half of 2020.

• Costs of revenues were $2.5 million for the quarter ended June 30, 2020. Costs of revenues have been impacted by a previous supply arrangement which has since been replaced by a current lower-cost supplier. We expect that the unit cost of inventories of EVOMELA will be considerably lower in the second half of 2020.

• Research and development expenses for the second quarter ended June 30, 2020 were $1.9 million, compared with $3.0 million for the same period in 2019. The decrease in R&D expenses is primarily due to reduced regulatory costs associated with our ANDAs and lower costs associated with preclinical development activities, offset by an increase in R&D expenses incurred related to the development of CID-103.

• General and administrative expenses for the second quarter of 2020 were $4.1 million, compared with $7.0 million for the same period in 2019. The decrease in G&A expenses was primarily because the 2019 period included costs related to sales and marketing efforts to prepare for the August 2019 launch of EVOMELA, as well as lower professional fees and travel costs incurred during the 2020 period.

• Selling and marketing expenses for the second quarter 2020 were $1.6 million. The increase is due to selling costs related to commercial sales of EVOMELA that began in August of 2019.

• Acquired in-process R&D expenses for the three months ended June 30, 2020 were $0 million, compared with $5.8 million for the same period in 2019, relating to the acquisition of the Black Belt license in April 2019.

• Net loss for the second quarter of 2020 was $8.5 million compared to $15.3 million for the same period in 2019.

• As of June 30, 2020, the Company had cash and cash equivalents of $44.9 million compared to $53.9 million as of March 31, 2020. As reported, the Company consummated an underwritten public offering in July 2020 generating gross proceeds of approximately $43.7 million.

-PR News Wire