Form 8-K - Current report

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:

99.1		Press Release of ImmuCell Corporation dated July 11, 2023
104		Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL).

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 No.		Description
99.1		Press Release of ImmuCell Corporation dated July 11, 2023
104		Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL).

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 4^th 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.

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“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

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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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Cover	Jul. 11, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jul. 11, 2023
Entity File Number	001-12934
Entity Registrant Name	ImmuCell Corporation
Entity Central Index Key	0000811641
Entity Tax Identification Number	01-0382980
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	56 Evergreen Drive
Entity Address, City or Town	Portland
Entity Address, State or Province	ME
Entity Address, Postal Zip Code	04103
City Area Code	207
Local Phone Number	878-2770
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.10 par value per share
Trading Symbol	ICCC
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false