# EDGAR Filing Document

**Accession Number:** 0000811641
**File Stem:** 0001213900-23-001673
**Filing Date:** 2023-1
**Character Count:** 15781
**Document Hash:** 6d1ee2cbfded5e62b37a2832c029f23c
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-23-001673.hdr.sgml**: 20230109

**ACCESSION NUMBER**: 0001213900-23-001673

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 13

**CONFORMED PERIOD OF REPORT**: 20230109

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230109

**DATE AS OF CHANGE**: 20230109

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** IMMUCELL CORP /DE/
- **CENTRAL INDEX KEY:** 0000811641
- **STANDARD INDUSTRIAL CLASSIFICATION:** IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835]
- **IRS NUMBER:** 010382980
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-12934
- **FILM NUMBER:** 23518204

**BUSINESS ADDRESS:**
- **STREET 1:** 56 EVERGREEN DR
- **CITY:** PORTLAND
- **STATE:** ME
- **ZIP:** 04103
- **BUSINESS PHONE:** 2078782770

**MAIL ADDRESS:**
- **STREET 1:** 56 EVERGREEN DRIVE
- **CITY:** PORTLAND
- **STATE:** ME
- **ZIP:** 04103

?xml version="1.0" encoding="utf-8"?

**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) <u>January 9, 2023</u>

**ImmuCell Corporation**

(Exact name of registrant as specified in its charter)

<u>DE</u> <u>001-12934</u> <u>01-0382980</u> <br> (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.)

<u>56 Evergreen Drive Portland, Maine</u> <u>04103</u> <br> (Address of principal executive offices) (Zip Code)

Registrant's telephone number, including area code <u>207-878-2770</u>

  <br> (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:

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| | |
|:---|:---|
| **Title of each class** | **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 January 9, 2023 ImmuCell Corporation (the "Company") issued a press release announcing the preliminary, unaudited product sales for the year ended December 31, 2022. 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) <u>Exhibits</u>.

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 January 9, 2023.](ea171435ex99-1_immucell.htm) <br> 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

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**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.

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| | | |
|:---|:---|:---|
|  | **IMMUCELL CORPORATION** | **IMMUCELL CORPORATION** |
| Date: January 9, 2023 | By: | */s/* Michael F. Brigham |
|  |  | Michael F. Brigham |
|  |  | President, Chief Executive Officer and<br> Principal Financial Officer |

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**Exhibit Index**

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | [Press Release of ImmuCell Corporation dated January 9, 2023](ea171435ex99-1_immucell.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

 ****

## Exhibit 99.1

**Exhibit 99.1**

**ImmuCell**

**ImmuCell Announces Preliminary, Unaudited Sales Results for the Year Ended December 31, 2022**

***<u>For Immediate Release</u>***

**PORTLAND, Maine – January 9, 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 year ended December 31, 2022.

---

| | | | | |
|:---|:---|:---|:---|:---|
| **<u>Preliminary, Unaudited Total Sales Results:</u>** | **<u>Preliminary, Unaudited Total Sales Results:</u>** | **<u>Preliminary, Unaudited Total Sales Results:</u>** | **<u>Preliminary, Unaudited Total Sales Results:</u>** | **<u>Preliminary, Unaudited Total Sales Results:</u>** |
|  | **2022** | **2021** | **($ Decrease)** | **(% Decrease)** |
| During the Three-Month Periods Ended December 31, | $3.91 million | $5.44 million | $(1.53 million) | (28.2)% |
| During the Twelve-Month Periods Ended December 31, | $18.57 million | $19.24 million | $(675000) | (3.5)% |

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As of December 31, 2022, there was a backlog of orders equal to approximately $2.5 million, representing an increase from approximately $205,000 as of September 30, 2022 and from approximately $2.4 million as of December 31, 2021. The Company believes that this backlog is a good indication of the strong demand for the **First Defense**<sup>®</sup> product line and supports the need for the investments the Company has made (and continues to make) to increase its production capacity.

"Our manufacturing plan for calendar year 2022 was to have the production equipment necessary to produce approximately $30-$35 million of product per year operational by July 1, 2022, but delays in the fabrication of certain critical equipment prevented this from happening," commented Michael F. Brigham, President and CEO of ImmuCell. "However, we did achieve our revised goal of having this equipment in place by the end of 2022, putting us in better shape as we begin 2023. This equipment implementation delay and a previously disclosed loss related to production contamination events which occurred around the end of the third quarter of 2022, very unfortunately, have prolonged our backlog status."

"We continue to work to achieve regulatory approval to commercialize **Re-Tain**<sup>®</sup>," Mr. Brigham concluded. "We still expect to make our third submission of the CMC Technical Section during the first quarter of 2023. When made, this submission will be subject to a six-month review by the FDA."

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**<u>Conference Call:</u>**

<br> 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 Wednesday, February 22, 2023 at 9:00 AM ET to discuss the full financial results for the year ended December 31, 2022. 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 March 1, 2023 at (877) 344-7529 (toll free) or (412) 317-0088 (international), utilizing replay access code #1239083. 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.

**<u>About ImmuCell:</u>**

<br> 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**<sup>®</sup>, providing **Immediate Immunity**™ to newborn dairy and beef calves, and is in the late stages of developing **Re-Tain<sup>®</sup>**, 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.

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| | |
|:---|:---|
| **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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**<u>Cautionary Note Regarding Forward-Looking Statements (Safe Harbor Statement):</u>**

This Press Release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any 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; factors that may affect the dairy and beef industries and future demand for our products; the extent, nature and duration of the COVID-19 pandemic and its consequences, and their direct and indirect impacts on our production activities, operating results and financial condition and on the customers and markets that we serve; the impact of Russia's unprovoked military invasion of Ukraine and attack on its people on the world economy including inflation and the price and availability of grain, oil, and natural gas; the impact of the global supply-chain disruptions on our ability to obtain, in a timely and cost-effective fashion, all the supplies and components we need to produce our products; the challenges in attracting and retaining needed personnel in this current employment environment; the impact of inflation and rising interest rates on our operating expenses and financial results and on our suppliers and customers; the effects of a potential United States or global recession on us and our direct and indirect customers, the duration and severity of which are difficult to predict or anticipate; the scope and timing of ongoing and future product development work and commercialization of our products; future costs of product development efforts; the estimated prevalence rate of subclinical mastitis and producers' level of interest in treating subclinical mastitis given the current economic and market conditions; 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 future 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 anticipated costs of (or time to complete) planned expansions of our manufacturing facilities and the adequacy of our funds available for these projects; the continuing availability to us on reasonable terms of third-party providers of critical products or services; the robustness of our manufacturing processes and related technical issues; estimates about our production capacity, efficiency and yield, which are highly subject to biological variability and the product format mix of our sales; the future adequacy of our working capital and the availability and cost of third-party financing; future regulatory requirements relating to our products; future expense ratios and margins; future compliance with bank debt covenants; costs associated with sustaining compliance with current Good Manufacturing Practice (cGMP) regulations in our current operations and attaining such compliance for our facilities to produce the Nisin Drug Substance and Drug Product; our effectiveness in competing against competitors within both our existing and our anticipated product markets; the cost-effectiveness of additional sales and marketing expenditures and resources; anticipated changes in our manufacturing capabilities and efficiencies; the value of our net deferred tax assets; projections about depreciation expense and its impact on income for book and tax return purposes; and any other statements that are not historical facts. Forward-looking statements can be identified by the use of words such as "expects", "may", "anticipates", "aims", "intends", "would", "could", "should", "will", "plans", "believes", "estimates", "targets", "projects", "forecasts", "seeks" and similar words and expressions. In addition, there can be no assurance that future developments affecting us will be those that we anticipate. Such statements involve risks and uncertainties, 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**<sup>®</sup> product line and **Re-Tain**<sup>®</sup>), 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 or excess inventory buildup), 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, our reliance upon third parties for financial support, products and services, our small size and dependence on key personnel, changes in laws and regulations, decision making and delays by regulatory authorities, a continuation or worsening of recent inflationary conditions and their impact on our customers' order patterns, uncertainty and possible adverse effects on us and our customers arising from an economic recession, currency values and fluctuations (that could make our products more expensive for international customers) and other risks 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, including the risk factors summarized above.

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