UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
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Item 2.02. Results of Operations and Financial Condition
On November 10, 2022, ImmuCell Corporation (the “Company”) issued a press release announcing the delay in its filing of its unaudited financial statements for the quarter ended September 30, 2022 until November 21, 2022 and its plans to conduct a conference call on Tuesday, November 22, 2022 at 9:00 AM ET to discuss its third quarter results. 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 4.02. Non-Reliance on Previously Issued Financial Statements or a Related Audit Report or Completed Interim Review
Based on discussions with the Audit Committee of the Board of Directors of the Company and with its Independent Registered Public Accounting Firm, Wipfli LLP, and after consultation with Company management, the Company concluded on November 8, 2022 that ImmuCell’s unaudited financial statements for the three-month period ended March 31, 2022 (filed as part of its Quarterly Report on Form 10-Q on May 12, 2022) and its unaudited financial statements for the three-month and six-month periods ended June 30, 2022 (filed as part of its Quarterly Report on Form 10-Q on August 11, 2022) (collectively the “Previously Issued Financial Statements”) should be restated to reflect the accrual of approximately $222,000 of deferred compensation expense (consisting of earned and unused paid time off) during the first quarter of 2022. This change increases the Company’s administrative expenses and accrued expenses by $222,000 with no impact on its cash position. There has been no change to previously disclosed product sales values.
The Audit Committee of the Company and its management concluded that the Company’s Previously Issued Financial Statements should be restated to correct the aforementioned error and that, accordingly, such Previously Issued Financial Statements should no longer be relied upon to that extent. Related press releases, investor presentations or other communications describing ImmuCell’s financial statements for these periods should no longer be relied upon to that extent.
The Company anticipates filing the restatements of the Previously Issued Financial Statements (through restatements of its previously filed Forms 10-Q), as well as the Quarterly Report on Form 10-Q containing the financial statements for the three-month and nine-month periods ended September 30, 2022, on a delayed basis. Management believes it can make these filings on November 21, 2022, which would be within five business days after the November 14, 2022 due date for the Quarterly Report on Form 10-Q containing the financial statements for the three-month and nine-month periods ended September 30, 2022.
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 November 10, 2022. | |
| 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.
| IMMUCELL CORPORATION | ||
| Date: November 10, 2022 | By: | /s/ Michael F. Brigham |
| Michael F. Brigham | ||
| President, Chief Executive Officer and Principal Financial Officer | ||
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Exhibit Index
| Exhibit No. | Description | |
| 99.1 | Press Release of ImmuCell Corporation dated November 10, 2022. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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Exhibit 99.1
ImmuCell
ImmuCell to Announce Unaudited Financial Results for
the Quarter Ended September 30, 2022
For Immediate Release
Conference Call Scheduled for Tuesday, November 22, 2022 at 9:00 AM ET
PORTLAND, Maine – November 10, 2022 – 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, expects to report unaudited financial results for the quarter ended September 30, 2022 after the market closes on Monday, November 21, 2022.
The Company has scheduled a conference call the next morning, Tuesday, November 22, 2022, at 9:00 AM ET to review its third quarter financial results. 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 November 29, 2022 at (877) 344-7529 (toll free) or (412) 317-0088 (international), utilizing replay access code #4621568.
The Company expects to file its Quarterly Report on Form 10-Q after the market closes on Monday, November 21, 2022. As described in the Company’s Current Report on Form 8-K that was filed on November 10, 2022, the Company is making this filing on a delayed basis to allow time to restate its financial statements for the quarters ended March 31, 2022 and June 30, 2022. This restatement is being made to correct a mistake related to deferred compensation expense (consisting of earned and unused paid time off) that resulted in the understatement of administrative expenses by approximately $222,000 during the first quarter of 2022. This correction had no impact on the Company’s cash position or product sales.
The Company anticipates no change to the preliminary sales results for the third quarter of 2022 that were disclosed on October 5, 2022.
Investors are encouraged to review the Company’s updated Corporate Presentation slide deck that provides an overview of the Company’s business which can be accessed under the “Investors” tab of the Company’s website at www.immucell.com, or by request to the Company, after the market closes on Monday, November 21, 2022.
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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 calves. 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 | ||
| [email protected] |
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Cautionary Note Regarding Forward-Looking Statements (Safe Harbor Statement):
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® 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 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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