ImmuCell Announces Unaudited Financial Results for Third Quarter of 2019
November 11 2019 - 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 third quarter and nine-month period ended September
30, 2019.
Management Discussion:“Total product sales
increased by 38% during the third quarter and by 25% during the
first nine months of 2019 versus the comparable periods during
2018. We continue to see favorable sales results during 2019
from investments in the First Defense® product
line,” commented Michael F. Brigham, President and CEO. “We are
growing and investing in infrastructure to fuel future growth.”
“We are the only veterinary biologic line offering measured
levels of antibody-driven immunity against bacterial and viral
scours providing Immediate Immunity™ to newborn
dairy and beef calves against the three most prevalent pathogens –
E. coli, coronavirus and rotavirus,” Mr. Brigham added.
“Given the increasing demand, we entered into a lease
covering 14,300 square feet of mostly manufacturing space during
the third quarter, as part of our $3 million investment to increase
production capacity for the First Defense® product
line. As dairy and beef producers move Beyond
Vaccination®, our expansion will allow
Tri-Shield® and Dual-Force® to
gain more market share from traditional scours vaccines that create
a variable vaccine response.”
“During the third quarter of 2019, the FDA conducted a
pre-approval inspection of our Drug Substance facility for
Re-Tain™, a novel treatment for subclinical
mastitis without a milk discard requirement that provides an
alternative to traditional antibiotics. As anticipated at
this early stage, some deficiencies were identified that need to be
resolved prior to commercial production and sales. We are confident
that we can effectively resolve the deficiencies to the FDA’s
satisfaction by the end of 2019 without significant cost or any
delay to the timeline to product approval,” Mr. Brigham
continued. “Simultaneously, we are advancing the early stages
of our $4 million investment to bring in-house the Drug Product
formulation and aseptic filling of syringes for
Re-Tain™.”
The Company expects to file its Quarterly Report on Form 10-Q on
Tuesday, November 12, 2019. Investors are encouraged to
review the Company’s updated Corporate Presentation slide deck that
provides an overview of the Company’s business and is available
under the “Investors” tab of the Company’s website at
www.immucell.com or by request to the Company.
Financial Results for the Third Quarter of
2019:
- During the quarter ended September 30, 2019, total product
sales increased by 38%, or $817,000, to $3 million from $2.2
million during the same period in 2018.
- During the nine-month period ended September 30, 2019, total
product sales increased by 25%, or $2 million, to $10.1 million
from $8 million during the same period in 2018.
- During the trailing twelve-month period ended September 30,
2019, total product sales increased by 17%, or $1.8 million, to $13
million from $11.2 million during the same period ended September
30, 2018.
- Product development expenses were $985,000 (including
depreciation and stock-based compensation expenses of $407,000)
during the three-month period ended September 30, 2019 in
comparison to $909,000 (including depreciation and stock-based
compensation expenses of $237,000) during the three-month period
ended September 30, 2018.
- Product development expenses were $2.7 million (including
depreciation and stock-based compensation expenses of $1.2 million)
during the nine-month period ended September 30, 2019 in comparison
to $2.3 million (including depreciation and stock-based
compensation expenses of $520,000) during the nine-month period
ended September 30, 2018.
- Net loss was $503,000, or $0.07 per share, during the third
quarter of 2019 in comparison to a net loss of $250,000, or $0.05
per share, during the third quarter of 2018.
- Net loss was $985,000, or $0.15 per share, during the
nine-month period ended September 30, 2019 in comparison to a net
loss of $1.3 million, or $0.23 per share, during the nine-month
period ended September 30, 2018.
Balance Sheet Data as of September 30,
2019:Largely as the result of the net proceeds of
approximately $8.3 million raised from an equity offering at the
end of the first quarter of 2019:
- Cash, cash equivalents and short-term investments increased to
$9.6 million as of September 30, 2019 from $2.5 million as of
December 31, 2018;
- Net working capital increased to $11.4 million as of September
30, 2019 from $3.9 million as of December 31, 2018; and
- Stockholders’ equity increased to $29.2 million as of September
30, 2019 from $21.7 million as of December 31, 2018.
Condensed Statements of
Operations (Unaudited)
|
|
|
|
|
During the Three-Month Periods Ended
September 30, |
|
During the Nine-MonthPeriods Ended
September 30, |
(In thousands, except per share amounts) |
2019 |
|
2018 |
|
2019 |
|
2018 |
|
|
|
|
|
|
|
|
Product sales |
$2,970 |
|
$2,154 |
|
$10,091 |
|
$8,049 |
Costs of goods sold |
1,519 |
|
1,203 |
|
5,189 |
|
4,252 |
Gross margin |
1,451 |
|
951 |
|
4,902 |
|
3,797 |
|
|
|
|
|
|
|
|
Product development expenses |
985 |
|
909 |
|
2,715 |
|
2,254 |
Sales, marketing and
administrative expenses |
896 |
|
891 |
|
2,898 |
|
2,764 |
Gain on sale of assets |
- |
|
(700) |
|
- |
|
(700) |
Operating activities, net |
1,881 |
|
1,100 |
|
5,613 |
|
4,318 |
|
|
|
|
|
|
|
|
NET OPERATING
LOSS |
(430) |
|
(149) |
|
(711) |
|
(521) |
|
|
|
|
|
|
|
|
Other expenses, net |
65 |
|
107 |
|
242 |
|
301 |
|
|
|
|
|
|
|
|
LOSS BEFORE INCOME
TAXES |
(495) |
|
(256) |
|
(953) |
|
(822) |
|
|
|
|
|
|
|
|
Income tax expense (benefit) |
8 |
|
(6) |
|
32 |
|
447 |
|
|
|
|
|
|
|
|
NET LOSS |
($503) |
|
($250) |
|
($985) |
|
($1,269) |
|
|
|
|
|
|
|
|
Basic weighted average common sharesOutstanding |
7,210 |
|
5,484 |
|
6,687 |
|
5,481 |
Basic net loss per share |
($0.07) |
|
($0.05) |
|
($0.15) |
|
($0.23) |
|
|
|
|
|
|
|
|
Diluted weighted average common shares outstanding |
7,210 |
|
5,484 |
|
6,687 |
|
5,481 |
Diluted net loss per share |
($0.07) |
|
($0.05) |
|
($0.15) |
|
($0.23) |
|
|
|
|
|
|
|
|
Selected Balance Sheet Data (In
thousands) (Unaudited)
|
|
|
|
|
|
As ofSeptember 30, 2019 |
|
As of December 31, 2018 |
|
|
|
|
|
|
Cash, cash equivalents and
short-term investments |
$ 9,555 |
|
$2,521 |
|
Net working capital |
11,397 |
|
3,856 |
|
Total assets |
38,848 |
|
32,731 |
|
Stockholders’ equity |
$29,189 |
|
$21,744 |
|
|
|
|
|
|
Non-GAAP Measures:Generally, a non-GAAP
financial measure is a numerical measure of a company’s
performance, financial position or cash flow that either excludes
or includes amounts that are not normally excluded or included in
the most directly comparable measure calculated and presented in
accordance with GAAP. A reader should review our Statements of Cash
Flows for a detailed understanding of our sources and uses of cash.
The non-GAAP measures included in this press release should be
considered in addition to, and not as a substitute for or superior
to, the comparable measure prepared in accordance with GAAP. We
believe that considering the non-GAAP income before income taxes
and certain non-cash expenses assists management and investors by
looking at our performance across reporting periods on a consistent
basis excluding certain charges (that are not uses of cash) from
our reported loss before income taxes. We start with our reported
loss before income taxes because presently we are not paying cash
for income taxes and do not anticipate paying cash for income taxes
in the near-term future. We calculate non-GAAP income before
income taxes and certain non-cash expenses as indicated in the
table below:
|
During the Three-Month Periods Ended September
30, |
|
During the Nine-MonthPeriods Ended
September 30, |
(In thousands) |
2019 |
|
2018 |
|
2019 |
|
2018 |
|
|
|
|
|
|
|
|
Loss before income taxes |
($495) |
|
($256) |
|
($953) |
|
($822) |
Depreciation, amortization and
stock-based compensation |
640 |
|
477 |
|
1,940 |
|
1,223 |
Income before income taxes and
certain non-cash expenses |
$ 145 |
|
$221 |
|
$987 |
|
$401 |
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 on Monday, November 11, 2019. A
teleconference replay of the call will be available for six days at
(877) 344-7529 (toll free) or (412) 317-0088 (international),
utilizing confirmation #10136525.
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
markets First Defense®, providing
Immediate Immunity™ to newborn dairy and beef
livestock, and is in the late stages of developing
Re-Tain™, 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.
Cautionary Note Regarding Forward-Looking Statements
(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: our
plans and strategies for our business; projections of future
financial or operational performance; the timing and outcome of
pending or anticipated applications for regulatory approvals;
factors that may affect the dairy and beef industries and future
demand for our products; 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; estimates about the market size for our products;
future market share of and revenue generated by current products
and products still in development; our ability to increase
production output and reduce costs of goods sold associated with
our new product, Tri-Shield First
Defense®; 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 anticipated costs of (or time to complete) planned expansions
of our manufacturing facilities and the adequacy of our funds
available for these projects; the continuing availability to us on
reasonable terms of third-party providers of critical products or
services; the robustness of our manufacturing processes and related
technical issues; estimates about our production capacity,
efficiency and yield; the future adequacy of our working capital
and the availability and cost of third-party financing; future
regulatory requirements relating to our products; future expense
ratios and margins; future compliance with bank debt covenants;
future cost of our variable interest rate exposure on most of our
bank debt; costs associated with sustaining compliance with current
Good Manufacturing Practice (cGMP) regulations in our current
operations and attaining such compliance for the facility to
produce the Nisin Drug Substance; implementation of international
trade tariffs that could reduce the export of dairy products, which
could in turn weaken the price received by our customers for their
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; anticipated changes in our manufacturing
capabilities and efficiencies; the value of our net deferred tax
assets; projections about depreciation expense and its impact on
income for book and tax return purposes; anticipated 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”, “seeks” 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
(including the First Defense® product line and
Re-Tain™), competition within our anticipated
product markets, customer acceptance of our new and existing
products, product performance, alignment between our manufacturing
resources and product demand, our reliance upon third parties for
financial support, products and services, changes in laws and
regulations, decision making and delays by regulatory authorities,
currency values and fluctuations and other risks detailed from time
to time in filings we make with the SEC, 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 involve risks and
uncertainties and are based on our current expectations, but actual
results may differ materially due to various factors, including the
risk factors summarized above.
Contacts: |
Michael
F. Brigham, President and CEO |
|
ImmuCell Corporation |
|
(207)
878-2770 |
|
|
|
Joe
Diaz, Robert Blum and Joe Dorame |
|
Lytham
Partners, LLC |
|
(602)
889-9700 |
|
iccc@lythampartners.com |
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