Full Press Release Details
Announces Financial Results for Second Quarter of 2017
Maine - August 14, 2017 - ImmuCell Corporation (NasdaqCM: ICCC), a growing animal health company that develops,
manufactures and markets scientifically-proven products that improve health and productivity in the dairy and beef industries,
today announced unaudited financial results for the quarter ended June 30, 2017.
quarter 2017 product sales were impacted by a record level of product sales during the first quarter of 2017. The first quarter
is historically the peak selling season for the Company's First Defense product line. The record sales
of the first quarter may have resulted in some distributors being fully stocked going into the second quarter of 2017. Further,
sales during the second quarter of the previous year included approximately $1 3 million in backlog orders that had been unfulfilled
from earlier months. Since the third quarter of 2016, the Company has had sufficient available inventory and is shipping in accordance
to the current demand of its distributors.
expect to build on the revenue generated in the first half of 2017 and report positive sales growth for the six-month and twelve-month
periods ending December 31, 2017, in comparison to the same periods during 2016," commented Michael F. Brigham, President
conditions in the dairy and beef industries, including milk pricing and prices for calves, weakened during 2016 in comparison
to 2015. Milk prices have made modest improvements going into 2017 over the annual averages for 2016 and 2015.
Income Statement Data:
Sheet Data as of June 30, 2017:
Development and Regulatory Update:
the fourth quarter of 2017, the Company expects to achieve regulatory approval of First Defense Tri-ShieldTm,
a new formulation of its bovine antibodies that combines the existing bivalent claims (against E. coli and coronavirus)
of the First Defense capsule with a new rotavirus claim in a gel tube delivery format. The Company is working
to also achieve regulatory approval of its bivalent gel tube formulation that is currently sold without disease claims as First
Defense Technology .
on New Mastitis Product:
the third quarter of 2016, the Company commenced construction, near its existing Portland, Maine facility, of a new
manufacturing facility that would enable ImmuCell to generate a purified, pharmaceutical-grade Nisin drug substance supply at
commercial scale. The facility is designed to have ample floor space for a second production line to be purchased and
installed in the future to effectively double production output after commercial acceptance of the product is demonstrated.
As planned, equipment installation was initiated during the third quarter of 2017, with installation and qualification
expected to be complete by year end. To gain regulatory approval of this product, three validation batches must be produced
at commercial scale, a detailed CMC Technical Section must be prepared and submitted to the FDA and successful FDA site
inspection(s) must be achieved. The Company expects to make the first submission of the CMC Technical Section to the FDA
during 2018. An additional submission is expected to be required. Each submission is subject to a six-month review by the
FDA. After approval of the final Technical Section, there is a 60-day administrative review before product license approval
could be issued. This timeline could support product approval and subsequent market launch, as anticipated, in the second
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. "We have displayed some pictures on our website
that show the significant progress being made on this project."
$10.1 million has been invested in the Nisin production facility project through June 30, 2017. The Company expects to pay for
the remaining $10 million of budgeted (and unpaid as of June 30, 2017) expenditures with its $4 3 million of cash on hand as of
June 30, 2017 and its $6 million of available bank debt. The available cash balance was increased by $1 million subsequent to
June 30, 2017 through the issuance of additional common stock.
on this project is expected to be largely complete by September 30, 2017.
is a bacteriocin that is not used in human medicines and would not contribute to the growing 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 product can provide this kind of value proposition.
parties can access the conference call scheduled by the Company to review these results by dialing (844) 855-9502 or (412) 317-5499
at 4:30 PM ET today. A teleconference replay of the call will be available for three days at (877) 344-7529 or (412) 317-0088,
confirmation #10111108.
Corporation's (NasdaqCM: ICCC) purpose is to create scientifically-proven and practical products that improve animal health
and productivity in the dairy and beef industries. 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).
Statements of (Loss) Income
| For the Three-Month Periods Ended June 30, | For the Six-Month Periods Ended June 30, | |||||||||||||||
| (In thousands, except per share amounts) | 2017 | 2016 | 2017 | 2016 | ||||||||||||
| Product sales | $ | 1,750 | $ | 2,376 | $ | 5,294 | $ | 5,362 | ||||||||
| Costs of goods sold | 828 | 1,136 | 2,220 | 2,365 | ||||||||||||
| Gross margin | 922 | 1,240 | 3,074 | 2,997 | ||||||||||||
| Sales, marketing and administrative expenses | 800 | 839 | 1,694 | 1,594 | ||||||||||||
| Product development expenses | 387 | 380 | 727 | 683 | ||||||||||||
| Operating expenses | 1,187 | 1,219 | 2,421 | 2,277 | ||||||||||||
| NET OPERATING (LOSS) INCOME | (265 | ) | 21 | 653 | 720 | |||||||||||
| Other expenses, net | 36 | 31 | 67 | 55 | ||||||||||||
| (LOSS) INCOME BEFORE INCOME TAXES | (301 | ) | (10 | ) | 586 | 665 | ||||||||||
| Income tax (benefit) expense | (83 | ) | (1 | ) | 220 | 222 | ||||||||||
| NET (LOSS) INCOME | $ | (218 | ) | $ | (9 | ) | $ | 366 | $ | 443 | ||||||
| Weighted average common shares outstanding: | ||||||||||||||||
| Basic | 4,848 | 4,179 | 4,848 | 4,006 | ||||||||||||
| Diluted | 4,848 | 4,179 | 4,943 | 4,117 | ||||||||||||
| NET (LOSS) INCOME PER SHARE: | ||||||||||||||||
| Basic | $ | (0.05 | ) | $ | (0.00 | ) | $ | 0.08 | $ | 0.11 | ||||||
| Diluted | $ | (0.05 | ) | $ | (0.00 | ) | $ | 0.07 | $ | 0.11 |
Selected Balance Sheet Data
| As of June 30, 2017 | As of December 31, 2016 | |||||||
| (In thousands) | ||||||||
| Cash, cash equivalents and short-term investments (1) | $ | 4,337 | $ | 10,624 | ||||
| Net working capital | 3,786 | 12,289 | ||||||
| Total assets | 28,062 | 24,697 | ||||||
| Stockholders' equity | $ | 20,196 | $ | 19,722 |
These balances do not include approximately $80 and $343 held temporarily in escrow against certain construction performance
requirements as of June 30, 2017 and December 31, 2016, respectively.
Diaz, Robert Blum and Joe Dorame
Lytham Partners, LLC
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; future market share of and revenue generated by current products and products still in development;
future sources of fmancial 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, 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 above.