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 ended September 30, 2024.
Q3 2024 Highlights:
- Product sales increased 11% over the comparable quarter in
2023.
- Product sales increased 51% over the comparable nine-month
period in 2023.
- Product sales increased 46% over the previous trailing
twelve-month period ended September 30, 2023.
Management’s Discussion:“Our preliminary,
unaudited product sales for the third quarter of 2024 were first
reported on October 8, 2024,” commented Michael F. Brigham,
President and CEO of ImmuCell. “We have no changes to those
figures.”
“We are excited about our sales growth compared to the prior
periods,” continued Mr. Brigham. “We have operated without another
contamination event since April of 2024, which leads us to believe
that the remediation steps that we have implemented in our
production process are keeping the bioburden within specification.
Now, we are focused on fixing our process yields to improve our
gross margin.”
“We have improved our cash position during 2024 pursuant to an
at the market offering at the expense of some stockholder ownership
dilution,” continued Mr. Brigham. “We think this has been necessary
to advance our strategic plan, which includes continuing to provide
First Defense® to the market as
we stabilize our production systems at a higher output level and
revolutionizing the way that subclinical mastitis is treated in
today’s dairy market with
Re-Tain®, our novel alternative
to traditional antibiotics that is in the FDA approval
process.”
“We continue to work to achieve FDA approval to commercialize
Re-Tain®,” concluded Mr. Brigham. “We plan to
provide an update when we have filed our Non-Administrative NADA,
which will include our fourth submission of the CMC Technical
Section, responding to the minor issues from the Incomplete Letter
issued in May of 2024, together with All Other Information and
Product Labeling. We anticipate making this submission shortly
after the inspectional observations at our contract manufacturer
are resolved to the satisfaction of the FDA. We have been in
discussions with the FDA to seek an expedited review once that
submission is made.”
Certain Financial Results:
- Product sales increased by 11%, or $615,000, to $6 million
during the three-month period ended September 30, 2024 compared to
$5.4 million during the three-month period ended September 30,
2023.
- Product sales increased by 51%, or $6.4 million, to $18.7
million during the nine-month period ended September 30, 2024
compared to $12.4 million during the nine-month period ended
September 30, 2023.
- Product sales increased by 46%, or $7.6 million, to $23.8
million during the trailing twelve-month period ended September 30,
2024 compared to $16.3 million during the trailing twelve-month
period ended September 30, 2023.
- Gross margin earned was 26% and 23% of product sales during the
three-month periods ended September 30, 2024 and 2023,
respectively. Gross margin earned was 27% and 21% of product sales
during the nine-month periods ended September 30, 2024 and 2023,
respectively.
- Net loss was $702,000, or $0.09 per basic share, during the
three-month period ended September 30, 2024 in comparison to a net
loss of $940,000, or $0.12 per basic share, during the three-month
period ended September 30, 2023. Net loss was $2.7 million, or
$0.34 per basic share, during the nine-month period ended September
30, 2024 in comparison to a net loss of $4.6 million, or $0.60 per
basic share during the nine-month period ended September 30,
2023.
- EBITDA (a non-GAAP financial measure described on page 5 of
this press release) improved to approximately $119,000 during the
three-month period ended September 30, 2024 in contrast to
approximately ($95,000) during the three-month period ended
September 30, 2023. EBITDA improved to approximately ($221,000)
during the nine-month period ended September 30, 2024 in comparison
to approximately ($2.3) million during the nine-month period ended
September 30, 2023.
Balance Sheet Data as of September 30,
2024:
- Cash and cash equivalents increased to $3.8 million as of
September 30, 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 $9.4 million as
of September 30, 2024 from $7.3 million as of December 31,
2023.
- Stockholders’ equity increased to $26.4 million as of September
30, 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 September
30, |
|
During the Nine-MonthPeriods Ended
September 30, |
|
(In thousands, except per share amounts) |
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
| |
|
|
|
|
|
|
|
| Product sales |
$6,012 |
|
|
$5,397 |
|
|
$18,742 |
|
|
$12,376 |
|
| Costs of goods sold |
|
4,428 |
|
|
|
4,130 |
|
|
|
13,633 |
|
|
|
9,764 |
|
|
Gross margin |
|
1,584 |
|
|
|
1,267 |
|
|
|
5,109 |
|
|
|
2,612 |
|
| |
|
|
|
|
|
|
|
| Product development
expenses |
|
786 |
|
|
|
1,118 |
|
|
|
3,079 |
|
|
|
3,328 |
|
| Sales, marketing and
administrative expenses |
|
1,374 |
|
|
|
1,333 |
|
|
|
4,292 |
|
|
|
4,028 |
|
|
Operating expenses |
|
2,160 |
|
|
|
2,451 |
|
|
|
7,371 |
|
|
|
7,356 |
|
| |
|
|
|
|
|
|
|
| NET OPERATING
LOSS |
|
(576) |
|
|
|
(1,184) |
|
|
|
(2,262) |
|
|
|
(4,744) |
|
| |
|
|
|
|
|
|
|
| Other expenses (income),
net |
|
124 |
|
|
|
(244) |
|
|
|
405 |
|
|
|
(113) |
|
| |
|
|
|
|
|
|
|
| LOSS BEFORE INCOME
TAXES |
|
(700) |
|
|
|
(940) |
|
|
|
(2,667) |
|
|
|
(4,631) |
|
| |
|
|
|
|
|
|
|
| Income tax expense |
|
2 |
|
|
|
- |
|
|
|
4 |
|
|
|
4 |
|
| |
|
|
|
|
|
|
|
| NET LOSS |
($702 |
) |
|
($940 |
) |
|
($2,671 |
) |
|
($4,635 |
) |
| |
|
|
|
|
|
|
|
|
Basic weighted average common shares outstanding |
|
8,164 |
|
|
|
7,747 |
|
|
|
7,908 |
|
|
|
7,747 |
|
|
Basic net loss per share |
($0.09 |
) |
|
($0.12 |
) |
|
($0.34 |
) |
|
($0.60 |
) |
|
|
|
|
|
|
|
|
|
|
Diluted weighted average common shares outstanding |
|
8,164 |
|
|
|
7,747 |
|
|
|
7,908 |
|
|
|
7,747 |
|
|
Diluted net loss per share |
($0.09 |
) |
|
($0.12 |
) |
|
($0.34 |
) |
|
($0.60 |
) |
| |
|
|
|
|
|
|
|
|
Selected Balance Sheet Data (In thousands)
(Unaudited) |
|
|
|
|
| |
As ofSeptember 30, 2024 |
|
As of December 31, 2023 |
|
| Cash and cash equivalents |
$3,809 |
|
$979 |
|
|
Net working capital |
|
9,422 |
|
|
7,272 |
|
| Total assets |
|
44,449 |
|
|
43,808 |
|
| Stockholders’ equity |
$26,412 |
|
$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 excluded
or included in 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 these certain charges that are not uses of cash from our
reported loss before income taxes. We calculate EBITDA
as described in the following table:
| |
| |
During the Three-Month Periods Ended September
30, |
|
During the Nine-Month Periods Ended
September 30, |
|
|
(In thousands) |
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
|
| |
|
|
|
|
|
|
|
|
| Loss before income taxes |
($700) |
|
|
($940) |
|
|
($2,667) |
|
|
($4,631) |
|
|
| Interest expense (excluding
debt issuance and debt discount costs) |
|
133 |
|
|
|
136 |
|
|
|
401 |
|
|
|
311 |
|
|
| Depreciation |
|
670 |
|
|
|
696 |
|
|
|
1,999 |
|
|
|
2,027 |
|
|
| Amortization (including debt
issuance and debt discount costs) |
|
16 |
|
|
|
13 |
|
|
|
46 |
|
|
|
27 |
|
|
| EBITDA |
$119 |
|
|
($95) |
|
|
($221) |
|
|
($2,266) |
|
|
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 $78,000 and $96,000 during the
three-month periods ended September 30, 2024 and 2023 and $257,000
and $268,000 during the nine-month periods ended September 30,
2024, and 2023, respectively. Cash payments to satisfy debt
repayment obligations or 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 Thursday,
November 14, 2024 at 9:00 AM ET to discuss the unaudited financial
results for the quarter ended September 30, 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 November 21, 2024 at
(877) 344-7529 (toll free) or (412) 317-0088 (international),
utilizing replay access code #6807288. 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 under the “Investors” tab
of the Company’s website after the market closes on Wednesday,
November 13, 2024.
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 in the late stages of
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 CEO
ImmuCell
Corporation
(207) 878-2770
Joe
Diaz, Robert Blum and Joe Dorame
Lytham Partners, LLC
(602)
889-9700iccc@lythampartners.com
ImmuCell (NASDAQ:ICCC)
과거 데이터 주식 차트
부터 10월(10) 2024 으로 11월(11) 2024
ImmuCell (NASDAQ:ICCC)
과거 데이터 주식 차트
부터 11월(11) 2023 으로 11월(11) 2024
