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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, 2023
| 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 |
|
Nasdaq |
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, 2023 ImmuCell Corporation (the “Company”)
issued a press release announcing its unaudited financial results for the quarter ended September 30, 2023. 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, 2023 |
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, 2023
For Immediate Release
PORTLAND, Maine – November 13, 2023 – 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, 2023.
Management’s Discussion:
“Our unaudited, preliminary product sales for the third quarter
of 2023 were first reported on October 5, 2023,” commented Michael F. Brigham, President and CEO of ImmuCell. “We have no
changes to those figures.”
“The production slowdown that was necessary to remediate several
contamination events materially impacted performance metrics during the first nine months of the year,” continued Mr. Brigham. “We
believe that the operational improvements and controls that we have implemented throughout the production process (from farm to finished
goods) will enable us to run more effectively and at a higher output level going forward.”
Finished goods produced increased steadily from approximately $3.3
million to $4 million and further to $5.3 million during the first, second and third quarters of 2023, respectively. The Company’s
goal is to be able to produce product with an estimated sales value of approximately $6 million per quarter, which would annualize to
about 80% of its estimated full production capacity of approximately $30 million.
“We are implementing and optimizing recent investments to increase
our production capacity and resume full production,” added Mr. Brigham. “Third quarter production was approximately 89% of
our quarterly objective.”
“At the same time, we remain poised and excited to revolutionize
the way that subclinical mastitis is treated in today’s dairy market with Re-Tain®, a novel alternative to
traditional antibiotics that is subject to FDA approval,” concluded Mr. Brigham.
Certain Financial Results:
| ● | Product sales increased by 13%, or $600,000, to $5.4 million during the three-month
period ended September 30, 2023 compared to $4.8 million during the three-month period ended September 30, 2022. |
| | | |
| ● | Product sales decreased by 16%, or $2.3 million, to $12.4 million during
the nine-month period ended September 30, 2023 compared to $14.7 million during the nine-month period ended September 30, 2022. |
| | | |
| ● | Product sales decreased by 19%, or $3.8 million, to $16.3 million during
the trailing twelve-month period ended September 30, 2023 compared to $20.1 million during the trailing twelve-month period ended September
30, 2022. |
| | | |
| ● | Gross margin earned was 23% and 38% of product sales during the three-month
periods ended September 30, 2023 and 2022, respectively, and 21% and 45% of product sales during the nine-month periods ended September
30, 2023 and 2022, respectively. The less than normal gross margin during 2023 was largely the result of product contamination events
in the production processes that resulted in a slowdown in output and write-offs of affected inventory. Remediation measures have been
implemented that are anticipated to mitigate or significantly reduce the risk of future contamination events. |
| | | |
| ● | Net loss was $940,000, or $0.12 per basic share,
during the three-month period ended September 30, 2023 in comparison to net loss of $655,000, or $0.08 per basic share, during the three-month
period ended September 30, 2022. |
| | | |
| ● | Net loss was $4.6 million, or $0.60 per basic share,
during the nine-month period ended September 30, 2023 in comparison to net loss of $826,000, or $0.11 per basic share, during the nine-month
period ended September 30, 2022. |
| | | |
| ● | EBITDA (a non-GAAP financial measure described on page 5 of this press release)
decreased to approximately ($95,000) during the three-month period ended September 30, 2023 from $71,000 during the three-month period
ended September 30, 2022 and to approximately ($2.3) million during the nine-month period ended September 30, 2023 from $1.3 million during
the nine-month period ended September 30, 2022. |
Balance Sheet Data as of September 30, 2023:
| ● | Cash and cash equivalents decreased to just under
$2 million as of September 30, 2023 from $5.8 million as of December 31, 2022, with no draw outstanding on the available $1 million line
of credit as of these dates. |
| | | |
| ● | Net working capital decreased to approximately $8.6
million as of September 30, 2023 from $10.9 million as of December 31, 2022. |
| | | |
| ● | Stockholders’
equity decreased to $26 million as of September 30, 2023 from $30.4 million as of December 31, 2022. |
Cautionary Note Regarding Forward-Looking Statements (Safe Harbor
Statement):
This Press Release and the statements to be made in the related earnings
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; dairy producers’ level of interest in treating subclinical mastitis given the current economic and market conditions;
the expected efficacy of new products; 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 effectiveness of 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 efficacy of our investments
in our business; anticipated changes in our manufacturing capabilities and efficiencies; 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 earnings 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) |
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
| Product sales |
|
$ |
5,397 |
|
|
$ |
4,796 |
|
|
$ |
12,376 |
|
|
$ |
14,657 |
|
| Costs of goods sold |
|
|
4,130 |
|
|
|
2,950 |
|
|
|
9,764 |
|
|
|
8,000 |
|
| Gross margin |
|
|
1,267 |
|
|
|
1,846 |
|
|
|
2,612 |
|
|
|
6,657 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Product development expenses |
|
|
1,118 |
|
|
|
1,270 |
|
|
|
3,328 |
|
|
|
3,444 |
|
| Sales, marketing and administrative expenses |
|
|
1,333 |
|
|
|
1,193 |
|
|
|
4,028 |
|
|
|
3,878 |
|
| Operating expenses |
|
|
2,451 |
|
|
|
2,463 |
|
|
|
7,356 |
|
|
|
7,322 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| NET OPERATING LOSS |
|
|
(1,184 |
) |
|
|
(617 |
) |
|
|
(4,744 |
) |
|
|
(665 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Other (income) expenses, net |
|
|
(244 |
) |
|
|
34 |
|
|
|
(113 |
) |
|
|
155 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| LOSS BEFORE INCOME TAXES |
|
|
(940 |
) |
|
|
(651 |
) |
|
|
(4,631 |
) |
|
|
(820 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Income tax expense |
|
|
- |
|
|
|
4 |
|
|
|
4 |
|
|
|
6 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| NET LOSS |
|
$ |
(940 |
) |
|
$ |
(655 |
) |
|
$ |
(4,635 |
) |
|
$ |
(826 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Basic weighted average common shares outstanding |
|
|
7,747 |
|
|
|
7,747 |
|
|
|
7,747 |
|
|
|
7,745 |
|
| Basic net loss per share |
|
$ |
(0.12 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.60 |
) |
|
$ |
(0.11 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Diluted weighted average common shares outstanding |
|
|
7,747 |
|
|
|
7,747 |
|
|
|
7,747 |
|
|
|
7,745 |
|
| Diluted net loss per share |
|
$ |
(0.12 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.60 |
) |
|
$ |
(0.11 |
) |
Selected Balance Sheet Data (In thousands)
(Unaudited)
| |
|
As of
September 30,
2023 |
|
|
As of
December 31,
2022 |
|
| Cash and cash equivalents |
|
$ |
1,989 |
|
|
$ |
5,792 |
|
| Net working capital |
|
|
8,634 |
|
|
|
10,923 |
|
| Total assets |
|
|
44,545 |
|
|
|
44,861 |
|
| Stockholders’ equity |
|
$ |
26,013 |
|
|
$ |
30,380 |
|
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) |
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
| Loss before income taxes |
|
$ |
(940 |
) |
|
$ |
(651 |
) |
|
$ |
(4,631 |
) |
|
$ |
(820 |
) |
| Interest expense (excluding debt issuance and debt discount costs) |
|
|
136 |
|
|
|
88 |
|
|
|
311 |
|
|
|
249 |
|
| Depreciation |
|
|
696 |
|
|
|
627 |
|
|
|
2,027 |
|
|
|
1,869 |
|
| Amortization |
|
|
13 |
|
|
|
7 |
|
|
|
27 |
|
|
|
20 |
|
| EBITDA |
|
$ |
(95 |
) |
|
$ |
71 |
|
|
$ |
(2,266 |
) |
|
$ |
1,318 |
|
EBITDA included stock-based compensation expense of approximately $96,000
and $85,000 during the three-month periods ended September 30, 2023 and 2022, respectively, and $268,000 and $201,000 during the nine-month
periods ended September 30, 2023 and 2022, respectively, which is a non-cash expense that we add back to EBITDA when assessing our cash
flows.
Conference Call:
The Company will host a conference call on Tuesday, November 14, 2023 at 9:00 AM ET to discuss the full unaudited financial results
for the quarter ended September 30, 2023. 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, 2023 at (877) 344-7529 (toll
free) or (412) 317-0088 (international), utilizing replay access code #5077962. 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.
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 with
a no milk discard claim 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 |
| Joe | Diaz, Robert Blum and Joe Dorame |
6
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- DefinitionTitle of a 12(b) registered security. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
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| X |
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-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
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