ImmuCell Announces Unaudited Financial Results for the Quarter Ended March 31, 2024
ImmuCell (Nasdaq: ICCC) reported a significant 111% year-over-year increase in product sales for Q1 2024, totaling $7.3 million. This marks the highest quarterly sales in the company's history. The trailing twelve-month sales also rose by 33%, reaching $21.3 million. Gross margin improved to 32%, up from 9% in Q1 2023. Despite these gains, the company reported a net loss of $438,000, a substantial improvement from the $2.3 million loss in the same period last year. EBITDA turned positive at $377,000 from a negative $1.6 million in Q1 2023. A backlog of $9.1 million in orders remains. However, cash reserves decreased slightly to $960,000. The FDA has delayed the approval of ImmuCell's Re-Tain® product due to pending inspectional observations at their contract manufacturer.
- Product sales increased 111% year-over-year to $7.3 million in Q1 2024.
- Record quarterly sales for the company.
- Trailing twelve-month sales up 33% to $21.3 million.
- Gross margin improved to 32% from 9% in Q1 2023.
- Net loss reduced to $438,000 from $2.3 million year-over-year.
- EBITDA turned positive to $377,000 from negative $1.6 million in Q1 2023.
- Backlog of orders worth $9.1 million as of March 31, 2024.
- Net loss of $438,000 reported in Q1 2024.
- Cash and cash equivalents decreased to $960,000.
- Net working capital decreased to $7.2 million.
- Stockholders' equity decreased to $24.6 million.
- FDA delayed Re-Tain® product approval due to pending inspectional observations.
Insights
ImmuCell Corporation has reported an impressive increase in product sales for the quarter ended March 31, 2024, recording a
In the trailing twelve-month period, sales rose by
On the balance sheet, cash and equivalents slightly decreased to
Short-term, the investor should note the company's push towards achieving
ImmuCell's focus on the animal health market, particularly dairy and beef cattle, is proving to be lucrative. The sharp recovery post-contamination issues indicates a strong demand for their products. The company’s ability to ramp up production and resolve past issues positions them well against competitors in the sector. The backlog, although slightly reduced from Q4 2023, remains significantly high, indicating sustained demand.
The emphasis on achieving production capacity near
Overall, the consistency in sales growth and improved gross margins are promising. The market’s response to ImmuCell's products and the company's ability to meet production targets will be important for sustained growth. Investors should monitor the FDA-related updates closely as it could pivot the strategic direction of the company.
The FDA's regulatory stance on ImmuCell’s Re-Tain® product introduces potential risks and delays. The Incomplete Letter from the FDA, while indicating minor queries, emphasizes that resolution of inspectional observations at the contract manufacturer’s facilities is critical for re-submission and approval. This could prolong the timeline for Re-Tain®'s market entry, affecting anticipated revenues.
The company’s proactive stance in working closely with the FDA and the contract manufacturer is essential to expedite this process. Investors should be aware of the regulatory landscape and the inherent uncertainties. The FDA's past performance with expedited reviews suggests some optimism, but there's an equal potential for delays if inspection issues persist.
From a legal standpoint, the company’s disclosures and steps to mitigate risks show preparedness and transparency. However, the dependency on a third-party contract manufacturer for compliance adds a layer of complexity, posing a risk factor that investors should consider in their risk assessments.
PORTLAND, Maine, May 14, 2024 (GLOBE NEWSWIRE) -- 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
After a slowdown during 2023 that was necessary to remediate certain production contamination events, finished goods produced increased steadily from approximately
“By implementing and optimizing a multi-year investment to increase our production capacity, we achieved
As the work to increase production output to meet demand continues, the backlog of orders was worth approximately
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% and9% 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
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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