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ImmuCell Corporation (Nasdaq: ICCC) is a biotechnology company headquartered in Portland, Maine. The company’s primary mission is to develop, manufacture, and market scientifically proven and practical products aimed at improving the health and productivity of dairy and beef cattle. These products are designed to make a measurable economic impact in the dairy and beef industries.
Operating within the healthcare sector, ImmuCell focuses on two main segments:
- Scours Segment: This segment is dedicated to the production and sale of First Defense®, a product designed to prevent scours in newborn calves. The product is regulated by the United States Department of Agriculture (USDA) and provides immediate immunity to newborn calves.
- Mastitis Segment: This segment focuses on the development and commercialization of Re-Tain®, a treatment for subclinical mastitis in lactating dairy cows. This product offers a novel alternative to traditional antibiotics and is regulated by the United States Food and Drug Administration (FDA).
During the third quarter of 2023, ImmuCell faced significant challenges due to contamination events, which impacted production and sales. Despite these setbacks, the company has implemented operational improvements and controls to enhance its production process. In the first three quarters of 2023, production output increased steadily, with finished goods production rising from approximately $3.3 million to $5.3 million. The company targets a quarterly production value of approximately $6 million, which would annualize to about 80% of its full production capacity.
Financially, ImmuCell reported a substantial increase in sales during the first quarter of 2024, achieving an all-time quarterly sales record of $7.3 million. This marks a 111% increase compared to the same period in 2023. The company's backlog of orders was around $9.1 million as of March 31, 2024, showing a significant increase from the previous year.
Looking ahead, ImmuCell continues to work towards FDA approval for Re-Tain®, with the goal of revolutionizing the treatment of subclinical mastitis in the dairy market. The company remains committed to increasing its production capacity and output to meet growing demand and aims to maintain production success going forward.
ImmuCell's innovative products and strategic focus on enhancing cattle health and productivity position the company as a significant player in the biotechnology and animal health sectors. For more information, visit the company's website at www.immucell.com.
ImmuCell provided an update on the regulatory status of its product development initiative for Re-Tain®. The company received a Technical Section Incomplete Letter from the FDA for its third submission of the CMC Technical Section, important for its NADA. ImmuCell has prepared a fourth submission but must clear inspectional observations at its facilities before submitting. The FDA confirmed acceptable inspectional status for ImmuCell, and its contract manufacturer expects to respond to inspectional observations by end of June 2024. The company anticipates a Non-Administrative NADA submission, possibly subject to a shorter review period, aiming for FDA approval and a controlled launch strategy between Q2 2025 and Q1 2026.
ImmuCell (Nasdaq: ICCC) has announced that its 2024 Annual Meeting of Stockholders will be held virtually on June 13, 2024, at 9:30 AM ET. The meeting will be conducted via telephone conference call and live audio webcast, not in person. Stockholders of record as of April 15, 2024, can participate by dialing specific toll-free numbers or accessing the webcast. Participation in the Q&A session post-meeting will be to the telephone call. A replay will be available until June 19, 2024. Stockholders are encouraged to vote in advance via proxy. More information is available on the company's website and SEC filings.
ImmuCell (Nasdaq: ICCC) reported a significant 111% year-over-year increase in product sales for Q1 2024, totaling $7.3 million. This marks the highest quarterly sales in the company's history. The trailing twelve-month sales also rose by 33%, reaching $21.3 million. Gross margin improved to 32%, up from 9% in Q1 2023. Despite these gains, the company reported a net loss of $438,000, a substantial improvement from the $2.3 million loss in the same period last year. EBITDA turned positive at $377,000 from a negative $1.6 million in Q1 2023. A backlog of $9.1 million in orders remains. However, cash reserves decreased slightly to $960,000. The FDA has delayed the approval of ImmuCell's Re-Tain® product due to pending inspectional observations at their contract manufacturer.
ImmuCell (Nasdaq: ICCC) will announce unaudited financial results for the quarter ended March 31, 2024 on May 14, 2024. The conference call to review the results is scheduled for May 15, 2024. Interested parties can access the call by dialing (844) 855-9502 (toll free) or (412) 317-5499 (international) at 9:00 AM ET. The Company expects no change to the preliminary sales results disclosed on April 9, 2024. Investors can review the updated Corporate Presentation slide deck on the Company's website.
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