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ImmuCell Announces Unaudited Financial Results for the Quarter and Year Ended December 31, 2024

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ImmuCell (ICCC) reported strong financial results for Q4 and full-year 2024, with product sales increasing 52% to $7.8 million in Q4 and $26.5 million for the full year. The company demonstrated significant operational improvements with gross margin expanding to 37% in Q4 2024 from 25% in Q4 2023.

The company achieved positive EBITDA of $1.3 million in Q4 2024, compared to negative ($311,000) in Q4 2023. Net income for Q4 2024 was $515,000 ($0.06 per share), versus a loss of ($1.14 million) in Q4 2023. Cash position strengthened to $3.8 million, up from $979,000 year-over-year.

ImmuCell has operated without contamination issues since April 2024, focusing on improving production yields and gross margins. The company continues to work towards FDA approval for Re-Tain®, with a recent submission of the Non-Administrative NADA in January 2025.

ImmuCell (ICCC) ha riportato risultati finanziari solidi per il quarto trimestre e l'intero anno 2024, con un aumento delle vendite di prodotti del 52%, raggiungendo 7,8 milioni di dollari nel Q4 e 26,5 milioni di dollari per l'intero anno. L'azienda ha dimostrato significativi miglioramenti operativi, con il margine lordo che è passato al 37% nel Q4 2024 rispetto al 25% nel Q4 2023.

L'azienda ha raggiunto un EBITDA positivo di 1,3 milioni di dollari nel Q4 2024, rispetto a un risultato negativo di ($311.000) nel Q4 2023. L'utile netto per il Q4 2024 è stato di 515.000 dollari (0,06 dollari per azione), rispetto a una perdita di ($1,14 milioni) nel Q4 2023. La posizione di cassa è migliorata a 3,8 milioni di dollari, in aumento rispetto a 979.000 dollari rispetto all'anno precedente.

ImmuCell ha operato senza problemi di contaminazione da aprile 2024, concentrandosi sul miglioramento dei rendimenti di produzione e dei margini lordi. L'azienda continua a lavorare per l'approvazione della FDA per Re-Tain®, con una recente presentazione del Non-Administrative NADA a gennaio 2025.

ImmuCell (ICCC) reportó resultados financieros sólidos para el cuarto trimestre y el año completo 2024, con un aumento del 52% en las ventas de productos, alcanzando 7,8 millones de dólares en el Q4 y 26,5 millones de dólares para el año completo. La compañía demostró mejoras operativas significativas, con un margen bruto que se expandió al 37% en el Q4 2024 desde el 25% en el Q4 2023.

La compañía logró un EBITDA positivo de 1,3 millones de dólares en el Q4 2024, en comparación con un resultado negativo de ($311,000) en el Q4 2023. El ingreso neto para el Q4 2024 fue de 515,000 dólares (0,06 dólares por acción), frente a una pérdida de ($1,14 millones) en el Q4 2023. La posición de efectivo se fortaleció a 3,8 millones de dólares, en comparación con 979,000 dólares año tras año.

ImmuCell ha operado sin problemas de contaminación desde abril de 2024, enfocándose en mejorar los rendimientos de producción y los márgenes brutos. La compañía continúa trabajando hacia la aprobación de la FDA para Re-Tain®, con una reciente presentación del Non-Administrative NADA en enero de 2025.

ImmuCell (ICCC)는 2024년 4분기 및 연간 실적이 강력하다고 보고하며, 4분기 제품 판매가 52% 증가하여 780만 달러에 달하고, 연간 판매는 2,650만 달러에 이르렀습니다. 회사는 2023년 4분기 25%에서 2024년 4분기 37%로 확대된 총 마진을 통해 상당한 운영 개선을 보여주었습니다.

회사는 2024년 4분기 EBITDA가 130만 달러로 긍정적이었으며, 2023년 4분기에는 부정적인 ($311,000)이었습니다. 2024년 4분기의 순이익은 515,000달러 ($0.06 per share)로, 2023년 4분기에는 ($1.14 million)의 손실이었습니다. 현금 보유액은 380만 달러로 강화되어, 전년 대비 979,000달러에서 증가했습니다.

ImmuCell은 2024년 4월 이후 오염 문제 없이 운영해 왔으며, 생산 수율 및 총 마진 개선에 집중하고 있습니다. 회사는 Re-Tain®의 FDA 승인을 위해 계속 노력하고 있으며, 2025년 1월에 비관리 NADA를 최근 제출했습니다.

ImmuCell (ICCC) a rapporté de solides résultats financiers pour le quatrième trimestre et l'année complète 2024, avec une augmentation des ventes de produits de 52%, atteignant 7,8 millions de dollars au Q4 et 26,5 millions de dollars pour l'année entière. L'entreprise a démontré des améliorations opérationnelles significatives, avec une marge brute passant à 37% au Q4 2024 contre 25% au Q4 2023.

L'entreprise a atteint un EBITDA positif de 1,3 million de dollars au Q4 2024, contre un résultat négatif de ($311,000) au Q4 2023. Le revenu net pour le Q4 2024 était de 515,000 dollars (0,06 dollars par action), contre une perte de ($1,14 million) au Q4 2023. La position de trésorerie s'est renforcée à 3,8 millions de dollars, contre 979,000 dollars d'une année sur l'autre.

ImmuCell a fonctionné sans problèmes de contamination depuis avril 2024, en se concentrant sur l'amélioration des rendements de production et des marges brutes. L'entreprise continue de travailler pour obtenir l'approbation de la FDA pour Re-Tain®, avec une récente soumission du Non-Administrative NADA en janvier 2025.

ImmuCell (ICCC) berichtete über starke finanzielle Ergebnisse für das vierte Quartal und das gesamte Jahr 2024, mit einem Anstieg der Produktverkäufe um 52% auf 7,8 Millionen Dollar im Q4 und 26,5 Millionen Dollar für das gesamte Jahr. Das Unternehmen zeigte signifikante betriebliche Verbesserungen mit einer Erhöhung der Bruttomarge auf 37% im Q4 2024 von 25% im Q4 2023.

Das Unternehmen erzielte ein positives EBITDA von 1,3 Millionen Dollar im Q4 2024, verglichen mit einem negativen Ergebnis von ($311.000) im Q4 2023. Der Nettogewinn für das Q4 2024 betrug 515.000 Dollar (0,06 Dollar pro Aktie), im Vergleich zu einem Verlust von ($1,14 Millionen) im Q4 2023. Die Liquiditätsposition verbesserte sich auf 3,8 Millionen Dollar, gegenüber 979.000 Dollar im Vorjahr.

ImmuCell hat seit April 2024 ohne Kontaminationsprobleme gearbeitet und konzentriert sich auf die Verbesserung der Produktionsausbeuten und der Bruttomargen. Das Unternehmen arbeitet weiterhin auf die FDA-Zulassung für Re-Tain® hin, mit einer kürzlichen Einreichung des Non-Administrative NADA im Januar 2025.

Positive
  • 52% sales growth to $7.8M in Q4 2024
  • Gross margin improved to 37% from 25% YoY
  • Positive EBITDA of $1.3M in Q4 vs negative prior year
  • Q4 net profit of $515,000 vs prior year loss
  • Cash position strengthened to $3.8M from $979K
  • Net working capital increased to $10.6M from $7.3M
Negative
  • Full-year net loss of $2.16M despite Q4 profit
  • Pending FDA approval creates uncertainty for Re-Tain launch
  • Previous contamination issues impacted production

Insights

ImmuCell's Q4 and full-year 2024 results reveal a compelling turnaround story, with the company demonstrating significant operational recovery and financial improvement. The 52% year-over-year revenue growth to $26.5 million for 2024 signals successful remediation of prior production constraints caused by contamination issues that had severely output since 2023.

Most impressive is ImmuCell's margin expansion, with gross margins improving from 25% to 37% in Q4 and from 22% to 30% for the full year. This 12 percentage point quarterly margin improvement reflects both production scaling benefits and enhanced manufacturing efficiency – not merely volume recovery. This operational leverage has translated directly to the bottom line, with the company achieving $515,000 in quarterly net income after multiple periods of losses.

The transition to positive EBITDA ($1.33 million in Q4, $1.11 million for the year) represents a critical inflection point for ImmuCell. With a strengthened balance sheet showing $3.8 million in cash (up from $979,000) and no debt drawn on their available line of credit, the company now has operational flexibility to pursue growth initiatives rather than focusing on survival.

Two key factors will determine ImmuCell's trajectory in 2025:

  • Production sustainability: The absence of contamination events since April 2024 suggests process improvements are working, but maintaining consistent, contamination-free production remains important for meeting market demand and further margin expansion.
  • Re-Tain regulatory approval: The January 2025 submission of ImmuCell's Non-Administrative NADA represents the fourth attempt to address FDA concerns. While management is seeking expedited review, approval timelines remain uncertain, with the company still awaiting clearance of inspectional observations at their contract manufacturer.

For investors, ImmuCell presents an intriguing risk-reward profile. With annual revenue now representing approximately 65% of its market capitalization, the company trades at a significant discount to animal health peers, likely reflecting lingering concerns about production consistency and the delayed Re-Tain approval. However, if the company can maintain its operational momentum and successfully commercialize Re-Tain, the current valuation could prove extremely conservative.

The key metric to watch in coming quarters will be gross margin progression. Management's explicit focus on "improving production yields and gross margins" suggests potential for further operational leverage, which could accelerate the path to consistent profitability beyond the Q4 results.

PORTLAND, Maine, Feb. 25, 2025 (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 and year ended December 31, 2024.

Product Sales Highlights:

  • Fourth quarter of 2024 product sales increased 52% to approximately $7.8 million compared to the fourth quarter ended December 31, 2023.
  • Full year of 2024 product sales increased 52% to approximately $26.5 million compared to the year ended December 31, 2023.

Management’s Discussion:

“Our preliminary, unaudited product sales for the fourth quarter and full year of 2024 were first reported on January 9, 2025,” commented Michael F. Brigham, President and CEO of ImmuCell. “We have no changes to those figures.”

“We have continued to operate without another contamination event since April of 2024, which leads us to believe that we have effectively remediated the problem and are keeping the bioburden within specification,” continued Mr. Brigham. “We are now focused on improving our production yields and gross margins.”

“The significant increase in sales over prior periods demonstrates the beginning of our recovery from a period when production was limited due to contamination events,” continued Mr. Brigham. “This sales growth, together with an improvement in gross margin from 25% during the fourth quarter of 2023 to 37% during the fourth quarter of 2024, helped us move EBITDA from negative to positive during the quarter and the year ended December 31, 2024, in contrast to negative EBITDA during the same periods of the prior year.”

“We continue to work to achieve FDA approval to commercialize Re-Tain®,” concluded Mr. Brigham. “The initiation of our Controlled Launch is pending FDA clearance of inspectional observations at the facilities of our contract manufacturer and the FDA’s review of our Non-Administrative NADA, which we submitted during early January of 2025. This submission includes All Other Information and Product Labeling as well as our fourth submission of the CMC Technical Section, responding to the minor, non-complex issues from the Incomplete Letter issued by the FDA in May of 2024. We have been in discussions with the FDA to seek an expedited review.”

Certain Financial Results:

  • Product sales increased by 52%, or $2.7 million, to $7.8 million during the three-month period ended December 31, 2024 compared to $5.1 million during the three-month period ended December 31, 2023.
  • Product sales increased by 52%, or $9 million, to $26.5 million during the year ended December 31, 2024 compared to $17.5 million during the year ended December 31, 2023.
  • Gross margin earned was 37% and 25% of product sales during the three-month periods ended December 31, 2024 and 2023, respectively.
  • Gross margin earned was 30% and 22% of product sales during the years ended December 31, 2024 and 2023, respectively.
  • Net income was $515,000, or $0.06 per diluted share, during the three-month period ended December 31, 2024 in contrast to a net loss of ($1,140,000), or ($0.15) per basic share, during the three-month period ended December 31, 2023.
  • Net loss was ($2,157,000) or ($0.26) per basic share, during the year ended December 31, 2024 in comparison to a net loss of ($5,775,000), or ($0.75) per basic share, during the year ended December 31, 2023.
  • EBITDA (a non-GAAP financial measure described on page 5 of this press release) improved to approximately $1,331,000 during the three-month period ended December 31, 2024 in contrast to approximately ($311,000) during the three-month period ended December 31, 2023. EBITDA improved to approximately $1,109,000 during the year ended December 31, 2024 in contrast to approximately ($2,577,000) during the year ended December 31, 2023.

Balance Sheet Data as of December 31, 2024:

  • Cash and cash equivalents increased to $3.8 million as of December 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 increased to approximately $10.6 million as of December 31, 2024 from $7.3 million as of December 31, 2023.
  • Stockholders’ equity increased to $27.5 million as of December 31, 2024 from $25 million as of December 31, 2023.

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 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 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; the salability of products currently held in inventory pending FDA approval; 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; our ability to convert the backlog of orders into sales; 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 December 31,
 During the Years Ended
December 31,
 
(In thousands, except per share amounts)2024  2023   2024   2023  
         
Product sales $7,751   $5,096   $26,493   $17,472  
Costs of goods sold 4,919   3,838   18,552   13,603  
Gross margin 2,832   1,258   7,941   3,869  
         
Product development expenses 819   1,066   3,899   4,395  
Sales, marketing and administrative expenses 1,391   1,195   5,682   5,222  
Operating expenses 2,210   2,261   9,581   9,617  
         
NET OPERATING INCOME (LOSS) 622   (1,003)  (1,640)  (5,748) 
         
Other expenses, net 101   135   507   22  
         
INCOME (LOSS) BEFORE INCOME TAXES 521   (1,138)  (2,147)  (5,770) 
         
Income tax expense 6   2   10   5  
         
NET INCOME (LOSS) $515   ($1,140)  ($2,157)  ($5,775) 
         
Basic weighted average common shares
outstanding
 8,935   7,750   8,167   7,748  
Basic net income (loss) per share $0.06   ($0.15)  ($0.26)  ($0.75) 
         
Diluted weighted average common shares
outstanding
 8,935   

7,750
   8,167   7,748  
Diluted net income (loss) per share $0.06   ($0.15)  ($0.26)  ($0.75) 


 Selected Balance Sheet Data (In thousands) (Unaudited)
     
 As of
December 31, 2024
 As of
December 31, 2023
 
Cash and cash equivalents$3,758 $979 
Net working capital10,631 7,272 
Total assets45,100 43,808 
Stockholders’ equity$27,518 $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 included in or excluded from 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 certain charges from our reported income (loss) before income taxes. We calculate EBITDA as described in the following table:

 During the Three-Month
Periods Ended December 31,
 During the Years Ended
December 31,
 
(In thousands) 2024   2023   2024   2023  
         
Income (loss) before income taxes $521   ($1,138)  ($2,147)  ($5,770) 
Interest expense (excluding debt issuance and debt discount costs) 125   142   526   453  
Depreciation 669   670   2,668   2,698  
Amortization (including debt issuance and debt discount costs) 16   15   62   42  
EBITDA $1,331   ($311)  $1,109   ($2,577) 
 

EBITDA included stock-based compensation expense (which is a non-cash expense that management adds back to EBITDA when assessing its cash flows) of approximately $69,000 and $101,000 during the three-month periods ended December 31, 2024 and 2023, respectively, and $326,000 and $369,000 during the years ended December 31, 2024, and 2023, respectively. Cash payments to satisfy debt repayment obligations and to make capital expenditure investments are other uses of cash that are not included in the calculation of EBITDA, which management also considers when assessing its cash flows.

Conference Call:

The Company is planning to host a conference call on Wednesday, February 26, 2025 at 9:00 AM ET to discuss the unaudited financial results for the quarter and year ended December 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 March 5, 2025 at (877) 344-7529 (toll free) or (412) 317-0088 (international), utilizing replay access code #5555700. 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 after the market closes on Tuesday, February 25, 2025.

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 developing Re-Tain®, a novel treatment for subclinical mastitis in dairy cows without FDA-required milk discard or meat withhold label restrictions 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

FAQ

What caused ImmuCell (ICCC) stock's 52% sales growth in Q4 2024?

The growth resulted from recovery after resolving production contamination issues, with Q4 sales reaching $7.8 million compared to $5.1 million in Q4 2023.

How did ImmuCell's (ICCC) gross margin improve in Q4 2024?

Gross margin improved to 37% in Q4 2024 from 25% in Q4 2023 due to better production efficiency and contamination control.

What is the status of ImmuCell's (ICCC) Re-Tain FDA approval process?

ImmuCell submitted Non-Administrative NADA in January 2025 and is awaiting FDA clearance of inspectional observations at contract manufacturer facilities.

How much did ImmuCell (ICCC) improve its cash position in 2024?

Cash increased to $3.8 million as of December 31, 2024, from $979,000 at the end of 2023.
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Biotechnology
In Vitro & in Vivo Diagnostic Substances
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