Full Press Release Details
Announces Financial Results for Third Quarter of 2017
Maine - November 13, 2017 - ImmuCell Corporation (Nasdaq: ICCC), a growing animal health company
that develops, manufactures and markets scientifically-proven products that improve the health and productivity of dairy and beef
cattle, today announced unaudited financial results for the quarter ended September 30, 2017.
to a sharp increase in sales (caused, in part, by the lack of supply to the market of a competitive product during late 2014 and
into the middle of 2015), the Company experienced a backlog of orders from early 2015 and through the middle of 2016, before doubling
its production capacity. Since the third quarter of 2016, the Company has had sufficient available inventory and is shipping in
accordance with the current demand of its distributors.
on these third quarter results, we expect to report positive sales growth during the fourth quarter of 2017, over both the third
quarter of 2017 and the fourth quarter of 2016," commented Michael F. Brigham, President and CEO. "We are preparing
to move forward into 2018 with an expanded product line (subject to the anticipated USDA approval of First Defense
Tri-Shield ) and with the impacts of both the order backlog and of the discontinuation of the topical wipes product
line out of our prior year comparatives."
Sheet Data as of September 30, 2017:
Development and Regulatory Update:
On November 13, 2017, the Company announced that it had achieved USDA approval of First Defense Tri-Shield ,
a new formulation that combines the existing First Defense bivalent claims (against E. coli and
coronavirus) with a guaranteed minimum level of rotavirus antibody content in a gel tube delivery format. This unique breadth
of claims further differentiates the Company's product from competitive calf-level products on the market that have claims
against both coronavirus and rotavirus or just E. coli or just coronavirus, but not all three. It also allows the Company
to better compete in the larger dam-level scours preventative market space. The Company's new marketing campaign, Beyond
Vaccination ', suggests that by delivering immediate immunity directly to the calf via First Defense
Tri-Shield , producers can avoid using such vaccines at dry-off and provide more consistent protection to the
calf at the calf-level.
on New Mastitis Product:
Certificate of Occupancy was issued by the City of Portland, Maine on October 30, 2017 for the Company's Nisin production
facility. On November 8, 2017, the Company held a ribbon-cutting' ceremony to celebrate the completion of the construction
phase of this $21 million project. This facility will be used by ImmuCell to produce purified, pharmaceutical-grade Nisin Drug
Substance at commercial scale. Adherence to the Company's anticipated timeline could lead to potential approval by the end
of 2019 with subsequent market launch.
Nisin production at commercial scale is the most critical action in front of us on the path to regulatory approval of our novel
treatment for subclinical mastitis," further commented Mr. Brigham. "Completing the facility construction in accordance
with our timeline was an important milestone on the road to commercialization of this product."
$14.6 million was invested in the Nisin production facility project through September 30, 2017. The Company expects to pay for
the remaining $6.2 million of budgeted expenditures (that were unpaid as of September 30, 2017) with its $2.3 million of cash
on hand as of September 30, 2017 and its $4.3 million of available bank debt and cash flows from operations.
is a bacteriocin that is not used in human medicines and would not contribute to the ongoing concern that the widespread use of
antibiotics could encourage the growth of antibiotic-resistant bacteria ("superbugs").
which costs the dairy industry about $2 billion per year, is currently treated with traditional antibiotic products, and treatment
is generally reserved for clinical infections when the cow produces non-saleable milk. The "zero milk discard" product
feature approved for ImmuCell's product would make earlier treatment of sick cows economically feasible, while these cows
are still producing saleable milk. No other existing product can provide this kind of value proposition.
Interested parties can access the conference call scheduled by the Company to review these results by dialing (844) 855-9502 (toll
free) or (412) 317-5499 (international) at 4:30 PM ET today. A teleconference replay of the call will be available for six days
at (877) 344-7529 (toll free) or (412) 317-0088 (international), confirmation #10113568.
Corporation's (Nasdaq: ICCC) purpose is to create scientifically-proven and practical products that improve the health
and productivity of dairy and beef cattle. ImmuCell has developed products that provide significant, immediate immunity to
newborn dairy and beef livestock. The Company is developing a novel treatment for mastitis, the most significant cause of economic
loss to the dairy industry. Press releases and other information about the Company are available at: (http://www.immucell.com).
Condensed Statements of (Loss) Income
| For the Three-Month Periods Ended September 30, | For the Nine-Month Periods Ended September 30, | |||||||||||||||
| (In thousands, except per share amounts) | 2017 | 2016 | 2017 | 2016 | ||||||||||||
| Product sales | $ | 2,005 | $ | 1,968 | $ | 7,298 | $ | 7,330 | ||||||||
| Costs of goods sold | 1,069 | 763 | 3,289 | 3,128 | ||||||||||||
| Gross margin | 936 | 1,205 | 4,009 | 4,202 | ||||||||||||
| Sales, marketing and administrative expenses | 832 | 846 | 2,527 | 2,440 | ||||||||||||
| Product development expenses | 586 | 308 | 1,312 | 991 | ||||||||||||
| Operating expenses | 1,418 | 1,154 | 3,839 | 3,431 | ||||||||||||
| NET OPERATING (LOSS) INCOME | (482 | ) | 51 | 170 | 771 | |||||||||||
| Other expenses, net | 49 | 27 | 115 | 81 | ||||||||||||
| (LOSS) INCOME BEFORE INCOME TAXES | (531 | ) | 24 | 55 | 690 | |||||||||||
| Income tax (benefit) expense | (192 | ) | (11 | ) | 28 | 212 | ||||||||||
| NET (LOSS) INCOME | ($ | 339 | ) | $ | 35 | $ | 27 | $ | 478 | |||||||
| Weighted average common shares outstanding: | ||||||||||||||||
| Basic | 4,993 | 4,183 | 4,897 | 4,065 | ||||||||||||
| Diluted | 4,993 | 4,302 | 4,999 | 4,179 | ||||||||||||
| NET (LOSS) INCOME PER SHARE: | ||||||||||||||||
| Basic | ($ | 0.07 | ) | $ | 0.01 | $ | 0.01 | $ | 0.12 | |||||||
| Diluted | ($ | 0.07 | ) | $ | 0.01 | $ | 0.01 | $ | 0.11 |
Selected Balance Sheet Data
| As of September 30, 2017 | As of December 31, 2016 | |||||||
| (In thousands) | ||||||||
| Cash, cash equivalents and short-term investments | $ | 2,305 | $ | 10,624 | ||||
| Net working capital | 2,691 | 12,289 | ||||||
| Total assets | 30,290 | 24,697 | ||||||
| Stockholders' equity | $ | 20,954 | $ | 19,722 |
Diaz, Robert Blum and Joe Dorame
Press Release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933
and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating
to: projections of future financial performance; the scope and timing of ongoing and future product development work and commercialization
of our products; future costs of product development efforts; the estimated prevalence rate of subclinical mastitis; the expected
efficacy of our new products; future market share of and revenue generated by current products and products still in development;
future sources of financial support for our product development, manufacturing and marketing efforts; the future adequacy of our
own manufacturing facilities or those of third parties with which we have contractual relationships to meet demand for our products
on a timely basis; the future adequacy of our working capital and the availability and cost of third party financing; timing and
future costs of a facility to produce the Drug Substance (our active pharmaceutical ingredient, Nisin); the timing and outcome
of pending or anticipated applications for regulatory approvals; future regulatory requirements relating to our products; future
expense ratios and margins; future compliance with bank debt covenants; costs associated with sustaining compliance with cGMP
regulations in our current operations and attaining such compliance for the facility to produce the Drug Substance; factors that
may affect the dairy and beef industries and future demand for our products; our effectiveness in competing against competitors
within both our existing and our anticipated product markets; the cost-effectiveness of additional sales and marketing expenditures
and resources; the accuracy of our understanding of our distributors' ordering patterns; anticipated changes in our manufacturing
capabilities and efficiencies; anticipated competitive and market conditions; and any other statements that are not historical
facts. Forward-looking statements can be identified by the use of words such as "expects", "may", "anticipates",
"aims", "intends", "would", "could", "should", "will",
"plans", "believes", "estimates", "targets", "projects", "forecasts"
and similar words and expressions. In addition, there can be no assurance that future developments affecting us will be those
that we anticipate. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties
relating to difficulties or delays in development, testing, regulatory approval, production and marketing of our products, competition
within our anticipated product markets, customer acceptance of our new and existing products, product performance, alignment between
our manufacturing resources and product demand, the uncertainties associated with product development and Drug Substance manufacturing,
actual as compared to expected or estimated costs of expanding our manufacturing facilities, our potential reliance upon third
parties for financial support, products and services, changes in laws and regulations, decision making by regulatory authorities,
possible dilutive impacts on existing stockholders from any equity financing transactions in which we may engage, currency values
and fluctuations and other risks detailed from time to time in filings we make with the Securities and Exchange Commission, including
our Quarterly Reports on Form 10-Q, our Annual Reports on Form 10-K and our Current Reports on Form 8-K. Such statements are based
on our current expectations, but actual results may differ materially due to various factors, including the risk factors discussed