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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) July 11, 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 July 11, 2023 ImmuCell Corporation (the "Company") issued
a press release announcing the preliminary, unaudited sales 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.
(d) 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: July 11, 2023 |
By: |
/s/ Michael F. Brigham |
|
|
Michael F. Brigham |
|
|
President, Chief Executive Officer and
Principal Financial Officer |
Exhibit Index
Exhibit 99.1
ImmuCell
ImmuCell Announces Preliminary, Unaudited Sales
Results
for Q2 2023
For Immediate Release
PORTLAND, Maine – July 11, 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 preliminary, unaudited sales results for the second quarter of 2023, which ended June 30, 2023.
Preliminary, Unaudited
Total Sales Results:
|
| |
2023 | | |
2022 | | |
($ Decrease) | | |
(% Decrease) | |
During the Three-Month Periods Ended June 30, | |
$3.53 million | | |
$3.86 million | | |
$(328,000) | | |
(9 | )% |
| |
| | |
| | |
| | |
| |
During the Six-Month Periods Ended June 30, | |
$6.98 million | | |
$9.86 million | | |
$(2.88 million) | | |
(29 | )% |
| |
| | |
| | |
| | |
| |
During the Twelve-Month Periods Ended June 30, | |
$15.69 million | | |
$20.46 million | | |
$(4.77 million) | | |
(23 | )% |
Sales during the three, six and twelve-month periods ended June 30,
2023 were below the comparable periods ended June 30, 2022 in large part because of the previously disclosed production slowdown implemented
during the first quarter of 2023 to remediate contamination events impacting the Company’s manufacturing process. Second quarter
sales increased modestly over the $3.45 million of sales recorded during the first quarter of 2023. Second quarter of 2023 sales could
have increased by more but narrowly missed benefiting from approximately $543,000 worth of finished goods inventory (valued at approximate
sales value) that did not ship until the beginning of July due to cold chain shipping requirements and the July 4th holiday
schedule. As of June 30, 2023, the backlog of orders was equal to approximately $8 million, representing a significant increase from approximately
$2.5 million as of December 31, 2022.
During the four-month period ended June 22, 2023, the standard quality
control test of incoming milk batches met specifications approximately 95% of the time, while approximately 2.5% failed with the balance
currently pending final testing and disposition. The two subsequent standard quality control tests at the middle and end of the production
process have continued to be within specification 100% of the time.
“This data supports our belief that our remediation efforts have
been successful and gives us confidence as we return to full production,” commented Michael F. Brigham, President and CEO of ImmuCell.
“For the month of June 2023 alone, production output - which includes the approximate sales value of about $543,000 worth of finished
goods inventory that did not ship until the beginning of July 2023 - increased to approximately $1.91 million in comparison to the monthly
average of approximately $1.08 million during the first five months of the year. We believe that this is a positive indicator for the
second half of 2023.”
“In addition, we continue to work to achieve FDA approval to
commercialize Re-Tain®,” Mr. Brigham concluded. “As disclosed on June 28, 2023, we expect to make our
third submission of the CMC Technical Section by the end of July 2023. When made, this submission will be subject to a six-month review
by the FDA.”
Conference Call:
Since the first quarter of 2020, the Company has been providing a preliminary look at its top line results soon after the close
of the quarter. The Company expects to provide this prompt, preliminary report on product sales until further notice going forward. The
Company will host a conference call on Friday, August 11, 2023 at 9:00 AM ET to discuss the full 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)
at 9:00 AM ET. 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 |
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; 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 impacts of backlogs on customer relationships; the efficacy or timeline to complete our contamination remediation
efforts; the likelihood, severity or adverse impact of future contamination events impacting our production process; the anticipated costs
of (or time to complete) planned expansions of our manufacturing facilities and the adequacy of our funds available for these projects;
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; the efficacy 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 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.
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