Benzinga | Feb 16, 2021 07:09AM EST

CASI Pharmaceuticals Sees Prelim. Q4 EVOMELA Sales ~$4.8M, Sees Prelim. FY20 EVOMELA Sales ~$15M

ROCKVILLE, MD., and BEIJING, Feb. 16, 2021 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today announced preliminary and unaudited revenues for the fourth quarter and full-year 2020 and provided an update on key highlights for 2021. '

Wei-Wu He, Ph.D., CASI's Chairman and Chief Executive Officer, commented, "We have taken a number of important strides as an organization in 2020, with four strategic pillars underpinning our overall corporate strategy: (1) Steady growth through ongoing business development, punctuated by the announcement of our licensing agreement with BioInvent in the fourth quarter, (2) Continued pre-commercialization preparations ahead of anticipated China NDA filing of CNCT19, CD19 CAR-T program, (3) Continued progress with respect to our current clinical pipeline, and (4) Strategic marketing execution and physician education with our commercial product, EVOMELA. Thanks to the tireless efforts of the CASI team, we have been able to successfully drive these initiatives forward and position ourselves for continued execution excellence in 2021."

Dr. He continued, "While the ongoing pandemic continues to present an array of headwinds from a macro perspective, our plans for 2021 are no less ambitious. We will continue to evaluate potential partners and/or assets that are tactically aligned with our own strategic growth objectives. We also expect to provide several key pipeline updates this year and remain on track to initiate our CID-103 study in multiple myeloma patients in the first quarter, while closely collaborating with our partners, Juventas and BioInvent, as they continue to execute internally. Our commercial team is making extensive preparations for the launch of CNCT19, for which Juventas is expecting to file a New Drug Application (NDA) with the National Medical Product Administration (NMPA) in 2021. And finally, we are pleased by the steady growth we have observed with EVOMELA, which has benefitted substantially from our continued marketing efforts and the manufacturing change we made in the second quarter; we look forward to reporting on our continued progress in the months to come."

Preliminary and Unaudited Fourth Quarter and Unaudited Full-Year 2020 Revenues, Cash Position, and 2021 EVOMELA(r) (melphalan for injection) Revenue Guidance

* The Company anticipates that it will report EVOMELA revenue of approximately $4.8 million for the fourth quarter ended December 31, 2020, and approximately $15 million for the full-year ended December 31, 2020, exceeding its projected $14 million guidance, and representing a 269% percent increase over 2019 revenue of $4.1 million.

* The Company is targeting full-year 2021 revenue guidance of more than 50% growth over 2020 for EVOMELA.

* CASI expects to report approximately $57.1 million of cash and cash equivalents as of December 31, 2020.

* The Company's fourth quarter and full-year 2020 revenues are preliminary and are subject to the completion of the Company's 2020 audit. Complete fourth quarter and full-year 2020 financial results will be reported in March.