On May 13, 2021 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 first quarter of 2021 (Press release, CASI Pharmaceuticals, MAY 13, 2021, View Source [SID1234579912]).
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Wei-Wu He, Ph.D., CASI’s Chairman, and Chief Executive Officer, commented, "We are pleased to report $5.7 million EVOMELA revenues for the quarter. For the full year 2021, we expect to meet our guidance of greater than 50% revenue growth. In addition to upward trend in EVOMELA revenue, our first quarter was marked by our new China partnership with Cleave Therapeutics for CB-5339, an exciting first-in-class VCP/p97 inhibitor being investigated for hematological malignancies and solid tumors. We also completed a $32.5 million capital raise at the end of March, from new fundamentally-driven, healthcare-dedicated investors, to strengthen our balance sheet."
Dr. He continued, "I am thrilled with the progress we are seeing across our hematology oncology product portfolio. With respect to our commercial asset CNCT-19 (CD19 CAR-T), our partner Juventas is making excellent progress with their current registration trials in B-NHL and B-ALL and is expecting to file NDAs in China by the end of 2021. Our CID-103 (anti-CD38 monoclonal antibody) Phase I trial remains on track with first patient dosing expected later this month, BI-1206 (anti-FcyRIIB monoclonal antibody) is on track with our China IND submission expected this year. We are excited by our momentum and will continue to execute on a number of key milestones across our broad portfolio in the quarters ahead."
First Quarter 2021 Financial Results
Revenues consisted primarily of product sales of EVOMELA that launched in August of 2019. Revenue was $5.7 million for the three months ended March 31, 2021, compared with $3.4 for the three months ended March 31, 2020.
Costs of revenues were $2.4 million for the quarter ended March 31, 2021, compared with $3.2 for the quarter ended March 31, 2020. The decrease in cost of revenues is due to the new alternate manufacturer now in place, resulting in a considerable decrease in the unit cost of inventories of EVOMELA. The decrease was partially offset by the continued growth in EVOMELA sales.
Research and development expenses for the three months ended March 31, 2021 were $5.3 million, compared with $3.0 million for the three months ended March 31, 2020. The increases in R&D expenses are primarily due to an increase in R&D expenses incurred related to the development of CID-103. Included in our research and development expenses for the three months ended March 31, 2021 are direct project costs of $3.5 million for preclinical development activities, primarily related to our CID-103 program, $0.5 million related to our ANDAs acquired in 2018, and $0.4 million for drugs in-licensed from Acrotech (previously Spectrum).
General and administrative expenses for the first quarter of 2021 were $5.5 million, compared with $4.1 million for the same period in 2020. The increase in general and administrative expenses was primarily due to an increase in headcount and payroll expenses as the Company continues to build its sales and marketing force.
Selling and marketing expenses for the first quarter 2021 were $2.7 million, compared with $1.3 for the same period in 2020.
Net loss for the first quarter of 2021 was $13.7 million compared to $8.2 million for the same period in 2020.
As of March 31, 2021, the Company had cash and cash equivalents of $68.1 million compared to $57.1million as of December 31, 2020.
Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, can be found at www.casipharmaceuticals.com.
Conference Call
The Company will host a conference call reviewing the first quarter highlights at 8:00 a.m. ET on Thursday, May 13, 2021. On the call, CASI’s Chairman & CEO will provide an update on the Company’s business and upcoming milestones. The conference call can be accessed by dialing (833) 420-0382 (U.S.), 8008700181 (China), 58086567 (Hong Kong) to listen to the live conference call. The conference ID number for the live call is 7478587.