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 March 31, 2024.
Management’s Discussion:“Our
preliminary, unaudited product sales for the first quarter of 2024
were first reported on April 9, 2024,” commented Michael F.
Brigham, President and CEO of ImmuCell. “We have no changes to
those figures.”
Total sales during the three-month period ended
March 31, 2024 were 111% above the comparable period ended March
31, 2023. Total sales during the trailing twelve-month period ended
March 31, 2024 were 33% above the comparable period ended March 31,
2023. The $7.3 million in sales recorded during the first quarter
of 2024 represents an all-time quarterly sales record for the
Company. The next highest quarter was $6 million recorded during
the first quarter of 2022.
After a slowdown during 2023 that was necessary
to remediate certain production contamination events, finished
goods produced increased steadily from approximately $3.3 million
to $4 million during the first and second quarters of 2023,
respectively, and then further to the average of $5.2 million per
quarter during the six-month period ended December 31, 2023. The
Company’s objective is to produce finished goods with an
approximate sales value of $6 million or more per quarter, which
would annualize to about 80% or more of its estimated full
production capacity of approximately $30 million. The actual value
of the Company’s production capacity varies based on biological and
process yields, product format mix, selling price and other
factors.
“By implementing and optimizing a multi-year
investment to increase our production capacity, we achieved $7.2
million of production during the first quarter of 2024, which
annualizes to $28.7 million, or about 96% of our $30 million full
capacity estimate,” continued Mr. Brigham.
As the work to increase production output to
meet demand continues, the backlog of orders was worth
approximately $9.1 million as of March 31, 2024, which is a small
decrease from approximately $9.4 million as of December 31, 2023
but still a large increase from approximately $2.5 million as of
December 31, 2022.Certain Financial Results:
- Product sales increased by 111%, or
$3.8 million, to $7.3 million during the three-month period ended
March 31, 2024 compared to $3.4 million during the three-month
period ended March 31, 2023.
- Product sales increased by 33%, or
$5.3 million, to $21.3 million during the trailing twelve-month
period ended March 31, 2024 compared to $16 million during the
trailing twelve-month period ended March 31, 2023.
- Gross margin earned was 32% and 9%
of product sales during the three-month periods ended March 31,
2024 and 2023, respectively. The lower gross margin during the
three-month period ended March 31, 2023 was largely the result of
product contamination events in the production processes that
resulted in a slowdown in output and write-offs of scrapped
inventory. Remediation measures have been implemented that are
anticipated to mitigate the risk of future contamination
events.
- Net loss was $438,000, or $0.06 per
basic share, during the three-month period ended March 31, 2024 in
comparison to a net loss of $2.3 million, or $0.30 per basic share,
during the three-month period ended March 31, 2023.
- EBITDA (a non-GAAP financial
measure described on page 5 of this press release) improved to
approximately $377,000 during the three-month period ended March
31, 2024 in contrast to ($1.6) million during the three-month
period ended March 31, 2023.
Balance Sheet Data as of March 31,
2024:
- Cash and cash equivalents decreased
to $960,000 as of March 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 decreased to
approximately $7.2 million as of March 31, 2024 from $7.3 million
as of December 31, 2023.
- Stockholders’ equity decreased to
$24.6 million as of March 31, 2024 from $25 million as of December
31, 2023.
Update on
Re-Tain® Product Development
Initiative:The FDA recently issued a CMC Technical Section
Incomplete Letter (Incomplete Letter) to the Company in response to
its third CMC Technical Section submission for
Re-Tain®. Pursuant to the Incomplete Letter, the
FDA has provided some minor questions about the Company’s
submission requiring a re-submission of the CMC Technical Section,
which is typically subject to a six-month review. However, the FDA
has indicated that this re-submission potentially could be handled
through a shortened review period because the open items are not
complex. More critical to the timeline, however, is that the FDA
has also required that the Company not re-submit the CMC Technical
Section until inspectional observations at the facilities of its
Drug Product (DP) contract manufacturer are resolved. Given the
unique facts and circumstances, the Company is working with the FDA
and its DP contract manufacturer to obtain an expedited review.
“We will remain focused on the commercial
opportunity we have with First Defense®, and we
intend to persist through yet another regulatory delay in our
effort to bring Re-Tain® to market,” Mr. Brigham
concluded.
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 or impact 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 efficacy or timeline to
complete our contamination remediation efforts; 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;
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; 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 March
31, |
|
(In thousands, except per share
amounts) |
2024 |
|
2023 |
|
|
|
|
|
|
Product sales |
$ |
7,258 |
|
|
$ |
3,447 |
|
|
Costs of goods sold |
|
4,963 |
|
|
|
3,146 |
|
|
Gross margin |
|
2,295 |
|
|
|
301 |
|
|
|
|
|
|
|
Product development expenses |
|
1,263 |
|
|
|
1,110 |
|
|
Sales, marketing and
administrative expenses |
|
1,332 |
|
|
|
1,447 |
|
|
Operating expenses |
|
2,595 |
|
|
|
2,557 |
|
|
|
|
|
|
|
NET OPERATING
LOSS |
|
(300 |
) |
|
|
(2,256 |
) |
|
|
|
|
|
|
Other expenses, net |
|
137 |
|
|
|
57 |
|
|
|
|
|
|
|
LOSS BEFORE INCOME
TAXES |
|
(437 |
) |
|
|
(2,313 |
) |
|
|
|
|
|
|
Income tax expense |
|
1 |
|
|
|
2 |
|
|
|
|
|
|
|
NET LOSS |
$ |
(438 |
) |
|
$ |
(2,315 |
) |
|
|
|
|
|
|
Basic weighted average common shares outstanding |
|
7,751 |
|
|
|
7,747 |
|
|
Basic net loss per share |
$ |
(0.06 |
) |
|
$ |
(0.30 |
) |
|
|
|
|
|
|
Diluted weighted average common shares outstanding |
|
7,751 |
|
|
|
7,747 |
|
|
Diluted net loss per share |
$ |
(0.06 |
) |
|
$ |
(0.30 |
) |
|
|
|
|
|
|
Selected Balance Sheet Data (In
thousands) (Unaudited)
|
As ofMarch 31, 2024 |
|
As ofDecember 31, 2023 |
|
Cash and cash equivalents |
$ |
960 |
|
$ |
979 |
|
Net working capital |
|
7,164 |
|
|
7,272 |
|
Total assets |
|
43,051 |
|
|
43,808 |
|
Stockholders’ equity |
$ |
24,636 |
|
$ |
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 March
31, |
|
(In thousands) |
2024 |
|
2023 |
|
|
|
|
|
|
Loss before income taxes |
$ |
(437 |
) |
|
$ |
(2,313 |
) |
|
Interest expense (excluding
debt issuance and debt discount costs) |
|
136 |
|
|
|
88 |
|
|
Depreciation |
|
663 |
|
|
|
652 |
|
|
Amortization |
|
15 |
|
|
|
7 |
|
|
EBITDA |
$ |
377 |
|
|
$ |
(1,566 |
) |
|
EBITDA included stock-based compensation expense
of approximately $81,000 and $96,000 during the three-month periods
ended March 31, 2024 and 2023, respectively, which is a non-cash
expense that management adds back to EBITDA when assessing its cash
flows. 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
considers when assessing its cash flows.
Conference Call:
The Company is planning to host a conference
call on Wednesday, May 15, 2024 at 9:00 AM ET to discuss the
unaudited financial results for the quarter ended March 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 May 22,
2024 at (877) 344-7529 (toll free) or (412) 317-0088
(international), utilizing replay access code #2581533. 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 Tuesday, May 14, 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 claims 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) 889-9700 |
|
|
iccc@lythampartners.com |
Grafico Azioni ImmuCell (NASDAQ:ICCC)
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