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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:
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 |
Exhibit Index
3
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.
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.
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.
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 |
|
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.
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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