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 its unaudited financial
results for the quarter and year ended December 31, 2024.
Product Sales Highlights:
- Fourth quarter of 2024 product sales increased 52% to
approximately $7.8 million compared to the fourth quarter ended
December 31, 2023.
- Full year of 2024 product sales increased 52% to approximately
$26.5 million compared to the year ended December 31, 2023.
Management’s Discussion:
“Our preliminary, unaudited product sales for the fourth quarter
and full year of 2024 were first reported on January 9, 2025,”
commented Michael F. Brigham, President and CEO of ImmuCell. “We
have no changes to those figures.”
“We have continued to operate without another contamination
event since April of 2024, which leads us to believe that we have
effectively remediated the problem and are keeping the bioburden
within specification,” continued Mr. Brigham. “We are now focused
on improving our production yields and gross margins.”
“The significant increase in sales over prior periods
demonstrates the beginning of our recovery from a period when
production was limited due to contamination events,” continued Mr.
Brigham. “This sales growth, together with an improvement in gross
margin from 25% during the fourth quarter of 2023 to 37% during the
fourth quarter of 2024, helped us move EBITDA from negative to
positive during the quarter and the year ended December 31, 2024,
in contrast to negative EBITDA during the same periods of the prior
year.”
“We continue to work to achieve FDA approval to commercialize
Re-Tain®,” concluded Mr. Brigham. “The initiation
of our Controlled Launch is pending FDA clearance of inspectional
observations at the facilities of our contract manufacturer and the
FDA’s review of our Non-Administrative NADA, which we submitted
during early January of 2025. This submission includes All Other
Information and Product Labeling as well as our fourth submission
of the CMC Technical Section, responding to the minor, non-complex
issues from the Incomplete Letter issued by the FDA in May of 2024.
We have been in discussions with the FDA to seek an expedited
review.”
Certain Financial Results:
- Product sales increased by 52%, or $2.7 million, to $7.8
million during the three-month period ended December 31, 2024
compared to $5.1 million during the three-month period ended
December 31, 2023.
- Product sales increased by 52%, or $9 million, to $26.5 million
during the year ended December 31, 2024 compared to $17.5 million
during the year ended December 31, 2023.
- Gross margin earned was 37% and 25% of product sales during the
three-month periods ended December 31, 2024 and 2023,
respectively.
- Gross margin earned was 30% and 22% of product sales during the
years ended December 31, 2024 and 2023, respectively.
- Net income was $515,000, or $0.06 per diluted share, during the
three-month period ended December 31, 2024 in contrast to a net
loss of ($1,140,000), or ($0.15) per basic share, during the
three-month period ended December 31, 2023.
- Net loss was ($2,157,000) or ($0.26) per basic share, during
the year ended December 31, 2024 in comparison to a net loss of
($5,775,000), or ($0.75) per basic share, during the year ended
December 31, 2023.
- EBITDA (a non-GAAP financial measure described on page 5 of
this press release) improved to approximately $1,331,000 during the
three-month period ended December 31, 2024 in contrast to
approximately ($311,000) during the three-month period ended
December 31, 2023. EBITDA improved to approximately $1,109,000
during the year ended December 31, 2024 in contrast to
approximately ($2,577,000) during the year ended December 31,
2023.
Balance Sheet Data as of December 31, 2024:
- Cash and cash equivalents increased to $3.8 million as of
December 31, 2024 from $979,000 as of December 31, 2023, with no
draw outstanding on the available $1 million line of credit as of
these dates.
- Net working capital increased to approximately $10.6 million as
of December 31, 2024 from $7.3 million as of December 31,
2023.
- Stockholders’ equity increased to $27.5 million as of December
31, 2024 from $25 million as of December 31, 2023.
Cautionary Note Regarding Forward-Looking Statements
(Safe Harbor
Statement):
This Press Release and the statements to be made in the related
conference call referenced herein contain “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended. Forward-looking statements can be
identified by the fact that they do not relate strictly to
historical or current facts and will often include words such as
“expects”, “may”, “anticipates”, “aims”, “intends”, “would”,
“could”, “should”, “will”, “plans”, “believes”, “estimates”,
“targets”, “projects”, “forecasts”, “seeks” and similar words and
expressions. Such statements include, but are not limited to, any
forward-looking 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; 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 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 per unit; the 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 likelihood, severity or impact of future
contamination events; the robustness of our manufacturing processes
and related technical issues; estimates about our production
capacity, efficiency and yield; the salability of products
currently held in inventory pending FDA approval; future regulatory
requirements relating to our products; future expense ratios and
margins; the effectiveness of our investments in our business;
anticipated changes in our manufacturing capabilities and
efficiencies; our effectiveness in competing against competitors
within both our existing and our anticipated product markets; our
ability to convert the backlog of orders into sales; and any other
statements that are not historical facts. These statements are
intended to provide management's current expectation of future
events as of the date of this press release, are based on
management's estimates, projections, beliefs and assumptions as of
the date hereof; and are not guarantees of future performance. Such
statements involve known and unknown risks and uncertainties that
may cause the Company's actual results, financial or operational
performance or achievements to be materially different from those
expressed or implied by these forward-looking statements,
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
(including the consequences of backlogs), uncertainty associated
with the timing and volume of customer orders as we come out of a
prolonged backlog, adverse impacts of supply chain disruptions on
our operations and customer and supplier relationships, commercial
and operational risks relating to our current and planned expansion
of production capacity, and other risks and uncertainties detailed
from time to time in filings we make with the Securities and
Exchange Commission (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. In addition, there can be no
assurance that future risks, uncertainties or developments
affecting us will be those that we anticipate. We undertake no
obligation to update any forward-looking statement, whether written
or oral, that may be made from time to time, whether as a result of
new information, future developments or otherwise.
Condensed Statements of Operations
(Unaudited) |
|
|
During the Three-Month Periods Ended December
31, |
|
During the Years Ended December 31, |
|
(In thousands, except per share amounts) |
2024 |
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$7,751 |
|
|
|
$5,096 |
|
|
|
$26,493 |
|
|
|
$17,472 |
|
|
Costs of
goods sold |
|
4,919 |
|
|
|
3,838 |
|
|
|
18,552 |
|
|
|
13,603 |
|
|
Gross margin |
|
2,832 |
|
|
|
1,258 |
|
|
|
7,941 |
|
|
|
3,869 |
|
|
|
|
|
|
|
|
|
|
|
Product
development expenses |
|
819 |
|
|
|
1,066 |
|
|
|
3,899 |
|
|
|
4,395 |
|
|
Sales,
marketing and administrative expenses |
|
1,391 |
|
|
|
1,195 |
|
|
|
5,682 |
|
|
|
5,222 |
|
|
Operating expenses |
|
2,210 |
|
|
|
2,261 |
|
|
|
9,581 |
|
|
|
9,617 |
|
|
|
|
|
|
|
|
|
|
|
NET OPERATING INCOME (LOSS) |
|
622 |
|
|
|
(1,003 |
) |
|
|
(1,640 |
) |
|
|
(5,748 |
) |
|
|
|
|
|
|
|
|
|
|
Other
expenses, net |
|
101 |
|
|
|
135 |
|
|
|
507 |
|
|
|
22 |
|
|
|
|
|
|
|
|
|
|
|
INCOME (LOSS) BEFORE INCOME TAXES |
|
521 |
|
|
|
(1,138 |
) |
|
|
(2,147 |
) |
|
|
(5,770 |
) |
|
|
|
|
|
|
|
|
|
|
Income
tax expense |
|
6 |
|
|
|
2 |
|
|
|
10 |
|
|
|
5 |
|
|
|
|
|
|
|
|
|
|
|
NET INCOME (LOSS) |
|
$515 |
|
|
|
($1,140 |
) |
|
|
($2,157 |
) |
|
|
($5,775 |
) |
|
|
|
|
|
|
|
|
|
|
Basic weighted average common sharesoutstanding |
|
8,935 |
|
|
|
7,750 |
|
|
|
8,167 |
|
|
|
7,748 |
|
|
Basic net income (loss) per share |
|
$0.06 |
|
|
|
($0.15 |
) |
|
|
($0.26 |
) |
|
|
($0.75 |
) |
|
|
|
|
|
|
|
|
|
|
Diluted weighted average common sharesoutstanding |
|
8,935 |
|
|
|
7,750 |
|
|
|
8,167 |
|
|
|
7,748 |
|
|
Diluted net income (loss) per share |
|
$0.06 |
|
|
|
($0.15 |
) |
|
|
($0.26 |
) |
|
|
($0.75 |
) |
|
Selected Balance Sheet Data (In thousands)
(Unaudited) |
|
|
|
|
|
|
As ofDecember 31, 2024 |
|
As ofDecember 31, 2023 |
|
Cash and cash equivalents |
$3,758 |
|
$979 |
|
Net
working capital |
10,631 |
|
7,272 |
|
Total
assets |
45,100 |
|
43,808 |
|
Stockholders’ equity |
$27,518 |
|
$24,993 |
|
|
Non-GAAP Financial 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 included
in or excluded from the most directly comparable measure calculated
and presented in accordance with GAAP. 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 measure of Earnings Before Interest, Taxes, Depreciation
and Amortization (EBITDA) assists management and investors by
looking at our performance across reporting periods on a consistent
basis excluding certain charges from our reported income (loss)
before income taxes. We calculate EBITDA as described in the
following table:
|
During the Three-Month Periods Ended December
31, |
|
During the Years Ended December 31, |
|
(In thousands) |
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income
taxes |
|
$521 |
|
|
|
($1,138 |
) |
|
|
($2,147 |
) |
|
|
($5,770 |
) |
|
Interest expense (excluding
debt issuance and debt discount costs) |
|
125 |
|
|
|
142 |
|
|
|
526 |
|
|
|
453 |
|
|
Depreciation |
|
669 |
|
|
|
670 |
|
|
|
2,668 |
|
|
|
2,698 |
|
|
Amortization (including debt
issuance and debt discount costs) |
|
16 |
|
|
|
15 |
|
|
|
62 |
|
|
|
42 |
|
|
EBITDA |
|
$1,331 |
|
|
|
($311 |
) |
|
|
$1,109 |
|
|
|
($2,577 |
) |
|
|
EBITDA included stock-based compensation expense (which is a
non-cash expense that management adds back to EBITDA when assessing
its cash flows) of approximately $69,000 and $101,000 during the
three-month periods ended December 31, 2024 and 2023, respectively,
and $326,000 and $369,000 during the years ended December 31, 2024,
and 2023, respectively. Cash payments to satisfy debt repayment
obligations and to make capital expenditure investments are other
uses of cash that are not included in the calculation of EBITDA,
which management also considers when assessing its cash
flows.Conference Call:The Company is planning to
host a conference call on Wednesday, February 26, 2025 at 9:00 AM
ET to discuss the unaudited financial results for the quarter and
year ended December 31, 2024. Interested parties can access the
conference call by dialing (844) 855-9502 (toll free) or (412)
317-5499 (international). A teleconference replay of the call will
be available until March 5, 2025 at (877) 344-7529 (toll free) or
(412) 317-0088 (international), utilizing replay access code
#5555700. 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. An updated version of the slide deck will be made
available after the market closes on Tuesday, February 25,
2025.
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 manufactures and markets First
Defense®, providing Immediate Immunity™
to newborn dairy and beef calves, and is developing
Re-Tain®, a novel treatment for subclinical
mastitis in dairy cows without FDA-required milk discard or meat
withhold label restrictions that provides an alternative to
traditional antibiotics. Press releases and other information about
the Company are available at: http://www.immucell.com.
Contacts: |
Michael F. Brigham, President and CEOImmuCell Corporation(207)
878-2770Joe Diaz, Robert Blum and Joe DorameLytham Partners,
LLC(602) 889-9700iccc@lythampartners.com |
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