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ImmuCell Makes Important Regulatory Submission and Announces Unaudited Financial Results for the Year Ended December 31, 2020
PORTLAND, Maine , Feb. 22, 2021 (GLOBE NEWSWIRE) -- ImmuCell Corporation (Nasdaq: ICCC) (“ImmuCell” or the “Company”), a growing animal health company that
About this update from Immucell Corporation
[{"type":"text","content":"PORTLAND, Maine , Feb. 22, 2021 (GLOBE NEWSWIRE) -- ImmuCell Corporation (Nasdaq: ICCC) (“ImmuCell” or the “Company”), a growing animal health company that develops, manufactures and markets scientifically proven and practical products that improve the health and productivity of dairy and beef cattle, today announced submission of a critical filing to the FDA related to Re-Tain™ and the Company’s unaudited financial results for the year ended December 31, 2020. Update on Regulatory Status of Re-Tain™:The Company recently submitted the last of five significant technical sections required to achieve FDA approval to market Re-Tain™, the Company’s mastitis product under development. A response from the FDA to this Chemistry, Manufacturing and Controls Technical Section is expected during the third quarter of 2021 after the statutory six-month review period. If the FDA issues a Technical Section Complete Letter, the Company would be able to begin initial, limited sales of Re-Tain™ during the fourth quarter of 2021 after the final sixty-day administrative review period. If the FDA issues a Technical Section Incomplete Letter, the Company would re-submit for another six-month review after responding to the FDA inquiries leading to potential market launch during the second quarter of 2022. The Company is taking a prudent approach and planning for a mass market launch during 2022. Product Sales Results: As previously announced, total product sales increased by $1.6 million, or 12%, to $15.3 million during the year ended December 31, 2020 compared to the year ended December 31, 2019.Sales of the First Defense® product line increased by 14% during the year ended December 31, 2020 compared to the year ended December 31, 2019.Total product sales increased by $111,000, or 3%, to $3.7 million during the three-month period ended December 31, 2020 compared to the three-month period ended December 31, 2019. Backlog of Orders:The Company reported a backlog of orders worth approximately $1.8 million as of December 31, 2020 compared to no backlog as of December 31, 2019. The Company projects that, during the first quarter of 2021, it may sell product equivalent to approximately 92% of the $4.1 million that it estimates to be its current production capacity per quarter, resulting in a sales decrease during the first quarter of 2021 compared to the fi...