ImmuCell Announces Preliminary Financial Results for Fourth Quarter and Full Year 2017
February 08 2018 - 4:05PM
ImmuCell Corporation (Nasdaq:ICCC)
(“ImmuCell” or the “Company”), a growing animal health company that
develops, manufactures and markets scientifically-proven and
practical products that improve the health and productivity of
dairy and beef cattle, today announced unaudited financial
results for the quarter and full year ended December 31, 2017.
- During the quarter ended December 31, 2017, total product sales
increased by approximately $919,000 to $3.1 million compared to
$2.2 million during the same period in 2016, an increase of
42%.
- During the year ended December 31, 2017, total product sales
increased by approximately $887,000 to $10.4 million compared to
$9.5 million during 2016, an increase of 9%. Total 2017
product sales included $97,000 in sales of the topical wipes
product line (that was discontinued during the first quarter of
2017) in comparison to $350,000 in sales of that product line
during 2016.
- Sales of the First Defense® product line
increased by 42% and 11% during the quarter and year ended December
31, 2017, respectively, in comparison to 2016.
- Depreciation and amortization expenses were $904,000 during the
year ended December 31, 2017 in comparison to $802,000 during the
year ended December 31, 2016.
- Cash provided by operating activities was approximately $1.2
million during the year ended December 31, 2017 in comparison to
cash (used for) operating activities of ($324,000) during the year
ended December 31, 2016.
- Net (loss) was ($195,000), or ($0.04) per share, for the fourth
quarter of 2017 in contrast to net income of $30,000, or $0.01 per
diluted share, during the fourth quarter of 2016.
- Net (loss) was ($168,000), or ($0.03) per share, during the
year ended December 31, 2017 in contrast to net income of $508,000,
or $0.12 per diluted share, during the year ended December 31,
2016.
- Product development expenses were $2,047,000 during the year
ended December 31, 2017 in comparison to $1,244,000 during the year
ended December 31, 2016, an increase of approximately
$802,000.
“We are moving forward into 2018 building on the solid top-line
growth achieved in 2017 and an expanded product line with the
November 2017 introduction of First Defense®
Tri-ShieldTM. We are pleased with the
initial sales of our new product,” commented Michael F. Brigham,
President and CEO. “Costs associated with the initial
production batches were higher and production output was lower than
we expect once the new product is in full production mode.
These are pretty typical challenges, as we scale up the production
process and learn about customer demand during a new product
launch. Further, the biological yield for the capsule format
of First Defense® declined, which does happen from
time to time for a product like ours. During the fourth
quarter, these negative factors drove gross margin and bottom-line
results lower than our historical (and projected) norm. We
plan to increase output and expect yields to improve during the
first half of 2018.”
Balance Sheet Data as of December 31,
2017:
- Cash, cash equivalents and short-term investments decreased to
$3.8 million as of December 31, 2017 from $10.6 million as of
December 31, 2016, and net working capital decreased to $5.4
million as of December 31, 2017 from $12.3 million as of December
31, 2016, as the Company neared completion of the build-out of its
new manufacturing facility.
- Stockholders’ equity increased to $23.6 million as of December
31, 2017 from $19.7 million as of December 31, 2016 due to equity
issuances that raised net proceeds of approximately $3.8 million
during 2017.
Product Development and Regulatory Review:
During the fourth quarter of 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 compete better against vaccines given to the mother cow
to prevent scours, which is a larger market. The Company’s
new marketing campaign, ‘Beyond Vaccination™’,
emphasizes that by delivering immediate immunity directly to the
calf via First Defense®
Tri-Shield™, producers can avoid using such
vaccines at dry-off (the period of time in between lactations) and
provide more consistent protection to the calf at the calf-level. A
Certificate of Occupancy was issued by the City of Portland, Maine
during the fourth quarter of 2017 for the Company’s $21 million
Nisin production facility. Approximately $19.2 million had
been spent on this project as of December 31, 2017. The
Company’s $3.8 million of cash on hand and $694,000 of available
bank debt as of December 31, 2017 plus its cash flows from
operations are more than sufficient to fund the remaining $1.8
million of budgeted expenditures on this project as of December 31,
2017. This facility will be used by ImmuCell to produce
purified, pharmaceutical-grade Nisin Drug Substance at commercial
scale and is an integral part of the Company’s effort to
commercialize its mastitis drug that is under development.
Adherence to the Company’s anticipated timeline could lead to
potential approval by the end of 2019 with subsequent market
launch. Nisin 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”). Mastitis, 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.
Conference Call: 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
#10116765.
About ImmuCell: ImmuCell 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 Operations
(Unaudited) |
|
|
For the Three-Month Periods
EndedDecember 31, |
|
For the Years EndedDecember
31, |
(In thousands, except
per share amounts) |
|
2017 |
|
|
|
2016 |
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
Product sales |
$ |
3,133 |
|
|
$ |
2,214 |
|
$ |
10,431 |
|
|
$ |
9,544 |
Costs of goods
sold |
|
1,921 |
|
|
|
995 |
|
|
5,210 |
|
|
|
4,123 |
Gross
margin |
|
1,212 |
|
|
|
1,219 |
|
|
5,221 |
|
|
|
5,421 |
|
|
|
|
|
|
|
|
Sales, marketing and
administrative expenses |
|
891 |
|
|
|
846 |
|
|
3,417 |
|
|
|
3,287 |
Product development
expenses |
|
734 |
|
|
|
254 |
|
|
2,047 |
|
|
|
1,244 |
Operating
expenses |
|
1,625 |
|
|
|
1,100 |
|
|
5,464 |
|
|
|
4,531 |
|
|
|
|
|
|
|
|
NET OPERATING
(LOSS) INCOME |
|
(413 |
) |
|
|
119 |
|
|
(243 |
) |
|
|
890 |
|
|
|
|
|
|
|
|
Other expenses,
net |
|
80 |
|
|
|
51 |
|
|
195 |
|
|
|
132 |
|
|
|
|
|
|
|
|
(LOSS) INCOME BEFORE INCOME TAXES |
|
(493 |
) |
|
|
68 |
|
|
(438 |
) |
|
|
758 |
|
|
|
|
|
|
|
|
Income tax (benefit)
expense |
|
(298 |
) |
|
|
38 |
|
|
(270 |
) |
|
|
250 |
|
|
|
|
|
|
|
|
NET (LOSS)
INCOME |
$ |
(195 |
) |
|
$ |
30 |
|
$ |
(168 |
) |
|
$ |
508 |
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding: |
|
|
|
|
|
|
|
Basic |
|
5,105 |
|
|
|
4,704 |
|
|
4,949 |
|
|
|
4,226 |
Diluted |
|
5,105 |
|
|
|
4,804 |
|
|
4,949 |
|
|
|
4,336 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET (LOSS)
INCOME PER SHARE: |
|
|
|
|
|
|
|
Basic |
$ |
(0.04 |
) |
|
$ |
0.01 |
|
$ |
(0.03 |
) |
|
$ |
0.12 |
Diluted |
$ |
(0.04 |
) |
|
$ |
0.01 |
|
$ |
(0.03 |
) |
|
$ |
0.12 |
|
|
|
|
|
|
|
|
|
|
Selected Balance Sheet Data (In
thousands) (Unaudited) |
|
|
|
|
As ofDecember 31,
2017 |
|
As of December 31,
2016 |
|
|
|
|
|
|
Cash, cash equivalents
and short-term investments |
$ |
3,799 |
|
$ |
10,624 |
|
Net working
capital |
|
5,443 |
|
|
12,289 |
|
Total assets |
|
34,299 |
|
|
24,697 |
|
Stockholders’
equity |
$ |
23,595 |
|
$ |
19,722 |
|
|
|
|
|
|
Safe Harbor Statement:
This 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 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 above.
Contacts:
Michael F. Brigham, President and CEOImmuCell Corporation(207)
878-2770
Joe Diaz, Robert Blum and Joe DorameLytham Partners, LLC(602)
889-9700iccc@lythampartners.com
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