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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported) November 13, 2024
| ImmuCell Corporation |
| (Exact
name of registrant as specified in its charter) |
| DE |
|
001-12934 |
|
01-0382980 |
(State or other jurisdiction
of incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
| 56 Evergreen Drive Portland, Maine |
|
04103 |
| (Address of principal executive
offices) |
|
(Zip Code) |
Registrant’s
telephone number, including area code 207-878-2770
| |
| (Former name
or former address, if changed since last report) |
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Registrant
under any of the following provisions:
| ☐ | Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
| Title
of each class |
|
Trading
symbol(s) |
|
Name
of each exchange on which registered |
| Common Stock, $0.10 par value per share |
|
ICCC |
|
The Nasdaq Capital Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
2.02. Results of Operations and Financial Condition
On
November 13, 2024 ImmuCell Corporation (the "Company") issued a press release announcing its unaudited financial results for
the quarter ended September 30, 2024. The full text of the press release issued in connection with the announcement is attached as Exhibit
99.1 to this Current Report on Form 8-K.
The
information shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange
Act") or otherwise subject to liabilities of that section, nor shall it be deemed incorporated by reference in any filing under
the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item
9.01. Financial Statements and Exhibits.
The
following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed:
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
| |
IMMUCELL CORPORATION |
| |
|
| Date: November
13, 2024 |
By: |
/s/
Michael F. Brigham |
| |
|
Michael F. Brigham |
| |
|
President, Chief Executive Officer and Principal Financial
Officer |
Exhibit
Index
3
Exhibit
99.1
ImmuCell
ImmuCell
Announces Unaudited Financial Results for the Quarter Ended September 30, 2024
For
Immediate Release
PORTLAND,
Maine – November 13, 2024 – 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-Month
Periods 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
of
September 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) 889-9700
iccc@lythampartners.com
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Grafico Azioni ImmuCell (NASDAQ:ICCC)
Storico
Da Ott 2024 a Nov 2024
Grafico Azioni ImmuCell (NASDAQ:ICCC)
Storico
Da Nov 2023 a Nov 2024
