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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)
August 10, 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 August 10, 2023 ImmuCell Corporation (the "Company")
issued a press release announcing its unaudited financial results for the quarter ended June 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: August 10, 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 June 30, 2023
For Immediate Release
PORTLAND, Maine – August 10, 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 June 30, 2023.
Management’s Discussion:
“Our unaudited, preliminary product sales were first reported
on July 11, 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 a production contamination event materially hurt performance during the first half of the year,” continued Mr. Brigham.
“We believe that the operational improvements we have implemented throughout the production process as part of this remediation
will help us run more effectively at a higher output level going forward.”
The Company is being driven by data as it resolves its temporary production
problem. Product is tested at the beginning, middle and end of the production process. During the trailing four-month period ended August
4, 2023, all three quality control tests have met standards 100% of the time. This improvement from the depth of the contamination problem
in January is allowing the Company to come back into full production.
“As we recover and resume full production, our goal is to be
able to produce approximately $6 million worth of product per quarter, which would annualize to about 80% of our estimated full production
capacity of approximately $30 million annually,” added Mr. Brigham.
“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,” concluded Mr. Brigham. “We are preparing to make our third submission of the CMC Technical Section
to the FDA for review shortly, which is a critical milestone in our efforts to commercialize this product.”
Certain Financial Results:
| ● | Product
sales decreased by 9%, or $329,000, to $3.5 million during the three-month period ended June
30, 2023 compared to $3.9 million during the three-month period ended June 30, 2022. |
| | |
| ● | Product
sales decreased by 29%, or $2.9 million, to $7.0 million during the six-month period ended
June 30, 2023 compared to $9.9 million during the six-month period ended June 30, 2022. |
| | |
| ● | Product
sales decreased by 23%, or $4.8 million, to $15.7 million during the trailing twelve-month
period ended June 30, 2023 compared to $20.5 million during the trailing twelve-month period
ended June 30, 2022. |
| | |
| ● | Gross
margin earned was 30% and 44% of product sales during the three-month periods ended June
30, 2023 and 2022, respectively, and 19% and 49% of product sales during the six-month periods
ended June 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 production output and a write-off of the affected inventory. Remediation
measures have been implemented that are anticipated to mitigate the risk of recurrence of
future contamination events. |
| | |
| ● | Net
loss was ($1.4) million, or ($0.18) per basic share, during the three-month period ended
June 30, 2023 in comparison to net loss of ($684,000), or ($0.09) per basic share, during
the three-month period ended June 30, 2022. |
| | |
| ● | Net
loss was ($3.7) million, or ($0.48) per basic share, during the six-month period ended June
30, 2023 in comparison to net loss of ($171,000), or ($0.02) per basic share, during the
six-month period ended June 30, 2022. |
| | |
| ● | EBITDA
(a non-GAAP financial measure described on page 5 of this press release) decreased to approximately
($605,000) during the three-month period ended June 30, 2023 from $37,000 during the three-month
period ended June 30, 2022 and to approximately ($2.2) million during the six-month period
ended June 30, 2023 from $1.2 million during the six-month period ended June 30, 2022. |
Balance Sheet Data as of June 30, 2023 (and
a subsequent event):
| ● | Cash
and cash equivalents decreased to $1.5 million as of June 30, 2023 from $5.8 million as of
December 31, 2022. |
| ● | Net
working capital decreased to approximately $6.8 million as of June 30, 2023 from $10.9 million
as of December 31, 2022. |
| ● | Stockholders’
equity decreased to $26.9 million as of June 30, 2023 from $30.4 million as of December 31,
2022. |
| ● | During
the third quarter of 2023, the Company closed on a $3 million debt facility that is repayable
under a seven-year amortization schedule with a balloon principal payment due in three years. |
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 June 30, | | |
During
the Six-Month Periods Ended June 30, | |
(In thousands, except per share amounts) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Product sales | |
$ | 3,533 | | |
$ | 3,861 | | |
$ | 6,979 | | |
$ | 9,861 | |
Costs of goods sold | |
| 2,489 | | |
| 2,154 | | |
| 5,635 | | |
| 5,051 | |
Gross margin | |
| 1,044 | | |
| 1,707 | | |
| 1,344 | | |
| 4,810 | |
| |
| | | |
| | | |
| | | |
| | |
Product development expenses | |
| 1,100 | | |
| 1,138 | | |
| 2,210 | | |
| 2,175 | |
Sales, marketing and administrative
expenses | |
| 1,248 | | |
| 1,188 | | |
| 2,695 | | |
| 2,684 | |
Operating expenses | |
| 2,348 | | |
| 2,326 | | |
| 4,905 | | |
| 4,859 | |
| |
| | | |
| | | |
| | | |
| | |
NET OPERATING LOSS | |
| (1,304 | ) | |
| (619 | ) | |
| (3,561 | ) | |
| (49 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other expenses, net | |
| 74 | | |
| 64 | | |
| 131 | | |
| 120 | |
| |
| | | |
| | | |
| | | |
| | |
LOSS BEFORE INCOME TAXES | |
| (1,378 | ) | |
| (683 | ) | |
| (3,692 | ) | |
| (169 | ) |
| |
| | | |
| | | |
| | | |
| | |
Income tax expense | |
| 2 | | |
| 1 | | |
| 3 | | |
| 2 | |
| |
| | | |
| | | |
| | | |
| | |
NET LOSS | |
$ | (1,380 | ) | |
$ | (684 | ) | |
$ | (3,695 | ) | |
$ | (171 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic weighted average common
shares outstanding | |
| 7,747 | | |
| 7,745 | | |
| 7,747 | | |
| 7,743 | |
Basic net loss per share | |
$ | (0.18 | ) | |
$ | (0.09 | ) | |
$ | (0.48 | ) | |
$ | 0.02 | ) |
| |
| | | |
| | | |
| | | |
| | |
Diluted weighted average common shares outstanding | |
| 7,747 | | |
| 7,745 | | |
| 7,747 | | |
| 7,743 | |
Diluted net loss per share | |
$ | (0.18 | ) | |
$ | (0.09 | ) | |
$ | (0.48 | ) | |
$ | (0.02 | ) |
Selected Balance Sheet Data (In thousands)
(Unaudited)
| |
As
of June 30, 2023 | | |
As
of December
31, 2022 | |
Cash and cash equivalents | |
$ | 1,454 | | |
$ | 5,792 | |
Net working capital | |
| 6,752 | | |
| 10,923 | |
Total assets | |
| 44,007 | | |
| 44,861 | |
Stockholders’ equity | |
$ | 26,857 | | |
$ | 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 June 30, | | |
During
the Six-Month Periods Ended June 30, | |
(In thousands) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Loss before income taxes | |
$ | (1,378 | ) | |
$ | (683 | ) | |
$ | (3,692 | ) | |
$ | (169 | ) |
Interest expense (excluding debt issuance costs) | |
| 87 | | |
| 89 | | |
| 175 | | |
| 162 | |
Depreciation | |
| 679 | | |
| 624 | | |
| 1,332 | | |
| 1,241 | |
Amortization | |
| 7 | | |
| 7 | | |
| 14 | | |
| 14 | |
EBITDA | |
$ | (605 | ) | |
$ | 37 | | |
$ | (2,171 | ) | |
$ | 1,248 | |
EBITDA included stock-based compensation expense
of approximately $76,000 and $62,000 during the three-month periods ended June 30, 2023 and 2022, respectively, and $172,000 and $116,000
during the six-month periods ended June 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 Friday,
August 11, 2023 at 9:00 AM ET to discuss the full unaudited financial results for the quarter ended June 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 August 19, 2023 at (877) 344-7529 (toll free) or (412) 317-0088 (international), utilizing replay
access code #5465238. 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 without
a milk discard requirement 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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ImmuCell (NASDAQ:ICCC)
Historical Stock Chart
From Apr 2024 to May 2024
ImmuCell (NASDAQ:ICCC)
Historical Stock Chart
From May 2023 to May 2024