0001213900-24-042926.txt : 20240514 0001213900-24-042926.hdr.sgml : 20240514 20240514160551 ACCESSION NUMBER: 0001213900-24-042926 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20240514 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240514 DATE AS OF CHANGE: 20240514 FILER: COMPANY DATA: COMPANY CONFORMED NAME: IMMUCELL CORP /DE/ CENTRAL INDEX KEY: 0000811641 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] ORGANIZATION NAME: 03 Life Sciences 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: 24944242 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 8-K 1 ea0206072-8k_immucell.htm CURRENT REPORT
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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) May 14, 2024

 

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   The Nasdaq Capital Market

 

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 May 14, 2024 ImmuCell Corporation (the “Company”) issued a press release announcing its unaudited financial results for the quarter ended March 31, 2024. 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 May 14, 2024.
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: May 14, 2024 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 May 14, 2024.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

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 EX-99.1 2 ea020607201ex99-1_immucell.htm PRESS RELEASE OF IMMUCELL CORPORATION DATED MAY 14, 2024

Exhibit 99.1

 

ImmuCell

 

 

ImmuCell Announces Unaudited Financial Results for

the Quarter Ended March 31, 2024

 

For Immediate Release

 

PORTLAND, Maine – May 14, 2024 – 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 March 31, 2024.

 

Management’s Discussion:

 

“Our preliminary, unaudited product sales for the first quarter of 2024 were first reported on April 9, 2024,” commented Michael F. Brigham, President and CEO of ImmuCell. “We have no changes to those figures.”

 

Total sales during the three-month period ended March 31, 2024 were 111% above the comparable period ended March 31, 2023. Total sales during the trailing twelve-month period ended March 31, 2024 were 33% above the comparable period ended March 31, 2023. The $7.3 million in sales recorded during the first quarter of 2024 represents an all-time quarterly sales record for the Company. The next highest quarter was $6 million recorded during the first quarter of 2022.

 

After a slowdown during 2023 that was necessary to remediate certain production contamination events, finished goods produced increased steadily from approximately $3.3 million to $4 million during the first and second quarters of 2023, respectively, and then further to the average of $5.2 million per quarter during the six-month period ended December 31, 2023. The Company’s objective is to produce finished goods with an approximate sales value of $6 million or more per quarter, which would annualize to about 80% or more of its estimated full production capacity of approximately $30 million. The actual value of the Company’s production capacity varies based on biological and process yields, product format mix, selling price and other factors.

 

“By implementing and optimizing a multi-year investment to increase our production capacity, we achieved $7.2 million of production during the first quarter of 2024, which annualizes to $28.7 million, or about 96% of our $30 million full capacity estimate,” continued Mr. Brigham.

 

As the work to increase production output to meet demand continues, the backlog of orders was worth approximately $9.1 million as of March 31, 2024, which is a small decrease from approximately $9.4 million as of December 31, 2023 but still a large increase from approximately $2.5 million as of December 31, 2022.

 

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Certain Financial Results:

 

●Product sales increased by 111%, or $3.8 million, to $7.3 million during the three-month period ended March 31, 2024 compared to $3.4 million during the three-month period ended March 31, 2023.
   
●Product sales increased by 33%, or $5.3 million, to $21.3 million during the trailing twelve-month period ended March 31, 2024 compared to $16 million during the trailing twelve-month period ended March 31, 2023.
   
●Gross margin earned was 32% and 9% of product sales during the three-month periods ended March 31, 2024 and 2023, respectively. The lower gross margin during the three-month period ended March 31, 2023 was largely the result of product contamination events in the production processes that resulted in a slowdown in output and write-offs of scrapped inventory. Remediation measures have been implemented that are anticipated to mitigate the risk of future contamination events.
   
●Net loss was $438,000, or $0.06 per basic share, during the three-month period ended March 31, 2024 in comparison to a net loss of $2.3 million, or $0.30 per basic share, during the three-month period ended March 31, 2023.
   
●EBITDA (a non-GAAP financial measure described on page 5 of this press release) improved to approximately $377,000 during the three-month period ended March 31, 2024 in contrast to ($1.6) million during the three-month period ended March 31, 2023.

 

Balance Sheet Data as of March 31, 2024:

 

●Cash and cash equivalents decreased to $960,000 as of March 31, 2024 from $979,000 as of December 31, 2023, with no draw outstanding on the available $1 million line of credit as of these dates.
   
●Net working capital decreased to approximately $7.2 million as of March 31, 2024 from $7.3 million as of December 31, 2023.
   
●Stockholders’ equity decreased to $24.6 million as of March 31, 2024 from $25 million as of December 31, 2023.

 

Update on Re-Tain® Product Development Initiative:

 

The FDA recently issued a CMC Technical Section Incomplete Letter (Incomplete Letter) to the Company in response to its third CMC Technical Section submission for Re-Tain®. Pursuant to the Incomplete Letter, the FDA has provided some minor questions about the Company’s submission requiring a re-submission of the CMC Technical Section, which is typically subject to a six-month review. However, the FDA has indicated that this re-submission potentially could be handled through a shortened review period because the open items are not complex. More critical to the timeline, however, is that the FDA has also required that the Company not re-submit the CMC Technical Section until inspectional observations at the facilities of its Drug Product (DP) contract manufacturer are resolved. Given the unique facts and circumstances, the Company is working with the FDA and its DP contract manufacturer to obtain an expedited review.

 

“We will remain focused on the commercial opportunity we have with First Defense®, and we intend to persist through yet another regulatory delay in our effort to bring Re-Tain® to market,” Mr. Brigham concluded.

 

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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 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 or impact 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 efficacy or timeline to complete 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 effectiveness 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 Press 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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Condensed Statements of Operations (Unaudited)

 

   During the Three-Month Periods Ended
March 31,		 
(In thousands, except per share amounts)  2024   2023 
         
Product sales  $7,258   $3,447 
Costs of goods sold   4,963    3,146 
Gross margin   2,295    301 
           
Product development expenses   1,263    1,110 
Sales, marketing and administrative expenses   1,332    1,447 
Operating expenses   2,595    2,557 
           
NET OPERATING LOSS   (300)   (2,256)
           
Other expenses, net   137    57 
           
LOSS BEFORE INCOME TAXES   (437)   (2,313)
           
Income tax expense   1    2 
           
NET LOSS  $(438)  $(2,315)
           
Basic weighted average common shares outstanding   7,751    7,747 
Basic net loss per share  $(0.06)  $(0.30)
           
Diluted weighted average common shares outstanding   7,751    7,747 
Diluted net loss per share  $(0.06)  $(0.30)

 

Selected Balance Sheet Data (In thousands) (Unaudited)

 

    As of
March 31,
2024		     As of
 December 31,
2023		  
Cash and cash equivalents   $ 960     $ 979  
Net working capital     7,164       7,272  
Total assets     43,051       43,808  
Stockholders’ equity   $ 24,636     $ 24,993  

 

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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 March 31, 
(In thousands)  2024   2023 
         
Loss before income taxes  $(437)  $(2,313)
Interest expense (excluding debt issuance and debt discount costs)   136    88 
Depreciation   663    652 
Amortization   15    7 
EBITDA  $377   $(1,566)

 

EBITDA included stock-based compensation expense of approximately $81,000 and $96,000 during the three-month periods ended March 31, 2024 and 2023, respectively, which is a non-cash expense that management adds back to EBITDA when assessing its cash flows. Cash payments to satisfy debt repayment obligations or to make capital expenditure investments are other uses of cash that are not included in the calculation of EBITDA, which management considers when assessing its cash flows.

 

Conference Call:

 

The Company is planning to host a conference call on Wednesday, May 15, 2024 at 9:00 AM ET to discuss the unaudited financial results for the quarter ended March 31, 2024. 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 May 22, 2024 at (877) 344-7529 (toll free) or (412) 317-0088 (international), utilizing replay access code #2581533. 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. An updated version of the slide deck will be made available under the “Investors” tab of the Company’s website after the market closes on Tuesday, May 14, 2024.

 

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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 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 FDA-required milk discard or meat withhold claims 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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