With expansion nearing completion, ImmuCell girds for FDA vetting
ImmuCell Corp., a publicly traded animal health company, is gearing up for more growth with a new, $20.8 million Portland production site.
The site, at 33 Caddie Lane in Portland, will be used to make an antimicrobial substance seen as having promising potential for treating mastitis in dairy cows.
“This is a significant milestone on a project worth over $20 million,” Michael F. Brigham, president and CEO, said in a news release. “We are right on the planned timeline and within a few percentage points of the dollar budget. We are proud to be bringing a unique, FDA-registered drug establishment to the state of Maine.”
Financing for the project was attained through TD Bank, along with the company's own cash flow and reserves.
In its quarterly filing with the Securities and Exchange Commission, ImmuCell reported: “The $20,803,000 investment we are making in a Nisin production facility is being funded from available cash and bank debt, together with cash flows from ongoing operations. As we complete the investment in our Nisin production facility and draw down the remaining bank debt that is available to us, we are reducing our cash reserves to a lower than normal level. We are going to be reliant on positive cash flows during our peak selling season (first quarter) to begin to re-build these cash reserves. Based on our best estimates and projections, we believe that we have sufficient capital resources to continue operations for at least twelve months.”
Elsewhere in the filing, ImmuCell reported that it had cash and cash equivalents of $2.3 million at Sept. 30, down from $5.15 million at Dec. 31, 2016. ImmuCell reported liabilities of $9.335 million at Sept. 30, up from $4.975 million at Dec. 31, 2016.
Nisin, the active ingredient to be produced in the new facility, is seen as having strong potential as a treatment for mastitis, the most significant cause of economic loss in the dairy industry.
ImmuCell expects equipment installation to be completed by the end of the year, which will be followed by development of commercial-scale process validation samples that will be submitted to the U.S. Food and Drug Administration by the middle of 2018. The projected timeline for FDA approval anticipates FDA approval by the end of 2019, which would be followed by a launch of the product in the dairy industry marketplace.
ImmuCell Corp. (Nasdaq: ICCC) has developed products that provide significant, immediate immunity to newborn dairy and beef livestock, it says.
In the quarter ended Sept. 30, ImmuCell recorded a net loss of $339,346, or 7 cents a share, compared to a profit of $34,870, or a penny a share, in the comparable period a year earlier. Sales for the third quarter totaled just over $2 million, up slightly from $1.968 million the same period a year earlier.
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