About ImmuCell

ImmuCell Corporation operates as an animal health company. The company supports the dairy and beef industries' purpose to produce nutritious proteins efficiently while ensuring food quality and safety. The company's products help address the growing human health concern about using less antibiotics in food-producing animals. The company intends to capitalize on the growth in sales of the First Defense product line (a product that provides significant Immediate Immunity to newborn dairy and beef livestock) and to revolutionize the mastitis treatment paradigm with Re-Tain, a novel product the company is developing to treat this most significant cause of economic loss to the dairy industry. Animal Health Products The First Defense product line is manufactured from hyperimmunized cows' colostrum (the antibody rich milk that a cow produces immediately after giving birth) utilizing the company's proprietary vaccine and milk protein purification technologies. The First Defense product line provides bovine antibodies that newborn calves need but are unable to produce on their own immediately after birth. The target disease, calf scours (bovine enteritis), causes diarrhea and dehydration in newborn calves and often leads to serious sickness and even death. The First Defense product line is the only USDA-licensed, orally delivered scours preventive product on the market for calves with claims against E. coli, coronavirus and rotavirus (three leading causes of scours). A single dose of the company's product provides a measured level of protection proven to reduce mortality and morbidity. The company's pre-formed antibody products provide Immediate Immunity during the first few critical weeks of life when calves need this protection most. Studies have shown calves that scour are more susceptible to other diseases later in life and under-perform calves that do not contract scours. The direct, two-part mode-of-action of the First Defense product line delivers specific immunoglobulins at the gut level to immediately protect against disease, while also providing additional antibodies that are absorbed into the bloodstream. These circulating antibodies function like a natural timed-release mechanism, as they are re-secreted into the gut later to provide extended protection. The First Defense product line is convenient to use. A calf needs to receive only one dose of First Defense within the first twelve hours after birth. The company's capsule format of this product, which requires no mixing, is stored at room temperature. The gel tube formats of this product require refrigeration in accordance with product label indications. During the third quarter of 2022, the company's cumulative sales of First Defense exceeded 30 million doses. The First Defense product line continues to benefit from wide acceptance by dairy and beef producers as an effective tool to prevent scours (diarrhea) in newborn calves, which is the leading cause of death in preweaned calves. The company's Beyond Vaccination marketing campaign focuses on providing antibodies without vaccination. A 100% vaccine protection rate is biologically impossible. The First Defense product line removes the variability associated with a scour vaccine response and instead provides a measured level of pre-formed antibodies, protecting each calf with an equal level of scours protection. The company is the only manufacturer within the scour prevention space offering polyclonal multi-pathogen antibodies. The product line extension, Tri-Shield First Defense, is the first calf-level, passive antibody product on the market with USDA-approved disease claims providing Immediate Immunity against each of the three leading causes of calf scours (E. coli, coronavirus and rotavirus). This product achieved USDA approval during the fourth quarter of 2017 and was listed with the Organic Materials Research Institute (OMRI) during the first quarter of 2019, which means it can be used on organic farms. Tri-Shield combines the E. coli and coronavirus antibodies contained in the company's bivalent product with rotavirus antibodies in a single-dose gel tube delivery format. This unique breadth of claims further differentiates its product from calf-level competitive products on the market that contain only one or two of these label claims. The unique virus-like particle (VLP) technology that is used in the company's production process increases rotavirus titers in colostrum to a level much greater than traditional vaccine technology can. Because it is possible that some farms may not have (or perceive to have) a rotavirus problem, the company is continuing to sell the bivalent formats of the First Defense product line as options for customers. The company's marketing campaign, Beyond Vaccination, emphasizes that by delivering Immediate Immunity directly to the calf via the First Defense product line, producers can reduce stress-causing injections to the cow. Reliance on a dam-level scours vaccine requires that money be spent before it is known whether the cow is carrying a viable, valued calf. With the First Defense product line, that investment can be targeted to the calves that are most critical to the operation. This, in turn, can free up space in the cow's vaccination schedule to improve her immune response to vaccines that are critical to her health. The company's communications campaign continues to emphasize how the unique ability of the First Defense product line to provide Immediate Immunity generates a dependable and competitive return on investment for dairy and beef producers. First Defense Technology is a unique whey protein concentrate that is processed utilizing the company's proprietary colostrum (first milk) protein purification methods, for the nutritional and feed supplement markets without the claims of its U.S. Department of Agriculture (USDA)-licensed product. During 2012, the company initiated a limited launch of a gel tube delivery format of its First Defense Technology in a gel solution. The company achieved USDA claims for this product format during the fourth quarter of 2018 and Canadian approval during the first quarter of 2019, and it is being sold as Dual-Force First Defense. The company is selling the same concentrated whey proteins in a bulk powder format (no capsule), which is delivered with a scoop and mixed with colostrum for feeding to calves. The company is working to achieve USDA claims for this product format. During 2011, Milk Products, LLC of Chilton, Wisconsin launched commercial sales of their product, Ultra Start 150 Plus and certain similar private label products, which are colostrum replacers with First Defense Technology Inside. During 2001, the company began to offer its own, internally developed California Mastitis Test (CMT). CMT is most often used as a quick on-farm diagnostic to determine which quarter of the udder is mastitic. This test can be performed at cow-side for early detection of mastitis. CMT products are also made by other manufacturers and are readily available to the dairy producer. In connection with the company's acquisition of certain gel formulation technologies during the first quarter of 2016, it acquired private label manufacturing rights covering a feed supplement product sold by Genex Cooperative, Inc. of Shawano, Wisconsin. This product was discontinued by mutual agreement during the first quarter of 2022. Sales and Markets The First Defense product line and CMT are sold primarily through major animal health distributors who, in turn, sell to veterinary clinics, fleet stores and direct to farms. Sales of the First Defense product line are normally seasonal, with higher sales expected during the first quarter(year ended December 2022), largely driven by the beef calving season, which runs primarily from January to April, unlike the dairy industry in which operations generally calve year round. Warm and dry weather reduces the producer's perception of the need for a disease preventative product like the First Defense product line. The company continues its efforts to grow sales of the First Defense product line in North America, where there are approximately 40 million dairy and beef cows in the United States and approximately 4.5 million dairy and beef cows in Canada. The majority of the company's international sales are to Canada. Generally, the company's international sales have been generated through relationships with in-country distributors that have knowledge of the local regulatory and marketing requirements. It is initiating its plan to expand the number of countries to which its First Defense product line is approved for export. The company introduced First Defense into South Korea through Medexx Co., Ltd of Gyeonggi-do, Korea and its equivalent into Japan through NYS Co., Ltd of Iwate, Japan. The company is working with Medexx (Medexx Co., Ltd of Gyeonggi-do, Korea)to expand its business in South Korea to include the registration of Tri-Shield First Defense. The business in Japan is not active, but the company is working to resume sales in this territory. The company entered into distribution contracts covering certain Middle Eastern countries with Triplest for Drugs and Trade of Madaba, Jordan during the first quarter of 2017 and covering Iran with Senikco, LLC of Laguna Niguel, California during the fourth quarter of 2016 (sales have been initiated under this contract). The company is investigating the requirements to sell the First Defense product line in Mexico, Pakistan and Israel. With Re-Tain, the company is working to expand its product portfolio to include an intramammary infusion for the treatment of subclinical mastitis in lactating dairy cows. The company intends to limit initial distribution of Re-Tain to a level that enables its sales team to select the optimal dairy farms at which to introduce Re-Tain and to limit the initial numbers of participating farms so that the desired levels of support and guidance relating to effective usage of Re-Tain can be provided with its available resources. The company continues to develop detailed launch plans, focusing on the readiness of dairy operators to successfully introduce Re-Tain to their herds. Intellectual Property The Nisin A that is produced from the company's proprietary strain of L. lactis is an essential component of its intellectual property covering Re-Tain. The company owns U.S. Patent No. 6,794,181 entitled 'Method of Purifying Lantibiotics', which covers a manufacturing process for preparing pharmaceutical-grade Nisin, which was issued in 2004; and U.S. Patent No. 10,023,617 entitled 'Methods and Systems of Producing Pharmaceutical Grade Lantibiotics', which covers key, novel and proprietary aspects of its manufacturing process for preparing pharmaceutical-grade Nisin and was issued during the third quarter of 2018. In the future, the company may file additional patent applications for certain products under development. There can be no assurance that patents will be issued with respect to any pending or future applications. In some cases, the company has chosen (and may choose in the future) not to seek patent protection for certain products or processes. In those instances, the company has sought (and may seek in the future) to maintain the confidentiality of any relevant intellectual property and other proprietary rights through operational measures and contractual agreements. The company owns numerous trademarks and trade dress that are very important to its business and has several trademark and trade dress registrations in the United States, Canada and Iran. The company owns the following U.S. trademark registrations: IMMUCELL, FIRST DEFENSE, FD FIRST DEFENSE (& Design), FIRST DEFENSE TECHNOLOGY, TRI-SHIELD FIRST DEFENSE, TRI-SHIELD FIRST DEFENSE (& Design), YOUR CALF CREW, BEYOND VACCINATION, BEYOND VACCINATION (& Design), CALF HERO, DUAL-FORCE, TRI-SHIELD and RE-TAIN. The company also owns U.S. registrations claiming rights in the color blue for its blue gel and blue bolus FIRST DEFENSE products. The United States Patent and Trademark Office refused registration of the company's IMMEDIATE IMMUNITY trademark, which it uses in connection with marketing of all of its products, on the grounds that the mark is generic. Rather than appeal this finding, the company is continuing to build its common law rights in the brand as it does with other brands from time to time. The FDA issued a determination that the name, MAST OUT, which the company had intended to use for its purified Nisin product, is overly promotional. Rather than continuing an appeal of this decision, the company selected a new product name, RE-TAIN, which was approved by the FDA during the first quarter of 2019. Government Regulation The company has received USDA and Canadian Food Inspection Agency approval for the bolus format of First Defense and for the gel tube formats of Tri-Shield First Defense and Dual-Force First Defense. Re-Tain is regulated by the U.S. Food and Drug Administration (FDA), which regulates veterinary drugs. Competition Zoetis sells a product that competes directly with the First Defense product line in preventing scours via oral delivery to newborn calves. With the rotavirus claim for its product (Tri-Shield First Defense), the company is competing against dam-level vaccine products that are given to the mother cow to increase the antibody level against scours-causing pathogens in the colostrum that she produces for her newborn. Those products are sold by Elanco (Scour Bos), Merck (Guardian) and Zoetis (ScourGuard). History ImmuCell Corporation was founded in 1982. The company was incorporated in Maine in 1982 and reincorporated in Delaware in 1987.