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ImmuCell Announces Preliminary, Unaudited Sales Results for Q4 and Full Year 2024

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ImmuCell (ICCC) reported strong preliminary, unaudited sales results for Q4 and full year 2024. The company achieved total sales of $7.8 million in Q4 2024, a 52% increase from $5.1 million in Q4 2023. Full-year 2024 sales reached $26.5 million, up 52% from $17.5 million in 2023.

Production output during Q4 2024 reached 103% of the company's estimated full capacity of $30 million per year. This helped reduce the order backlog to $4.4 million as of January 1, 2025, down from $9.4 million a year earlier. The company attributes the current backlog to strong demand as distributors replenish buffer stocks and end-users place orders ahead of peak calving season.

ImmuCell also reported progress on Re-Tain®, with the recent submission of its Non-Administrative NADA to the FDA, including the fourth CMC Technical Section submission and discussions about expedited review.

ImmuCell (ICCC) ha riportato risultati preliminari di vendita forti e non verificati per il quarto trimestre e l'intero anno 2024. La compagnia ha raggiunto vendite totali di 7,8 milioni di dollari nel quarto trimestre del 2024, con un aumento del 52% rispetto ai 5,1 milioni di dollari nel quarto trimestre del 2023. Le vendite per l'intero anno 2024 hanno raggiunto 26,5 milioni di dollari, in aumento del 52% rispetto ai 17,5 milioni di dollari nel 2023.

La produzione durante il quarto trimestre del 2024 ha raggiunto il 103% della capacità totale stimata dell'azienda, pari a 30 milioni di dollari all'anno. Questo ha contribuito a ridurre l'arretrato degli ordini a 4,4 milioni di dollari al 1° gennaio 2025, in calo rispetto ai 9,4 milioni di dollari dell'anno precedente. L'azienda attribuisce l'attuale arretrato alla forte domanda, poiché i distributori riforniscono le scorte e gli utenti finali effettuano ordini in anticipo rispetto alla stagione di picco dei parti.

ImmuCell ha anche segnalato progressi su Re-Tain®, con la recente presentazione della sua Non-Administrative NADA all'FDA, compresa la quarta presentazione della Sezione Tecnica CMC e discussioni riguardanti una revisione accelerata.

ImmuCell (ICCC) informó resultados de ventas preliminares, no auditados, sólidos para el cuarto trimestre y el año completo 2024. La compañía alcanzó ventas totales de $7.8 millones en el cuarto trimestre de 2024, un aumento del 52% respecto a $5.1 millones en el cuarto trimestre de 2023. Las ventas del año completo 2024 alcanzaron $26.5 millones, un incremento del 52% respecto a $17.5 millones en 2023.

La producción durante el cuarto trimestre de 2024 alcanzó el 103% de la capacidad total estimada de la compañía de $30 millones por año. Esto ayudó a reducir el retraso de pedidos a $4.4 millones al 1 de enero de 2025, lo que representa una disminución desde $9.4 millones un año antes. La compañía atribuye el retraso actual a la fuerte demanda, ya que los distribuidores reponen los stocks de reserva y los usuarios finales realizan pedidos anticipados antes de la temporada alta de pariciones.

ImmuCell también informó sobre avances en Re-Tain®, con la reciente presentación de su NADA No Administrativa a la FDA, que incluye la cuarta presentación de la Sección Técnica CMC y discusiones sobre una revisión acelerada.

ImmuCell (ICCC)는 2024년 4분기 및 전체 연도에 대한 강력한 예비 비감사 매출 실적을 보고했습니다. 회사는 2024년 4분기에 의 총 매출을 달성했으며, 이는 2023년 4분기 5.1 백만 달러에서 52% 증가한 수치입니다. 2024년 전체 매출은 $26.5 백만 달러에 도달하며, 2023년 17.5백만 달러에서 52% 증가했습니다.

2024년 4분기 동안 생산량은 연간 3천만 달러의 회사 추정 최대 용량의 103%에 도달했습니다. 이는 2025년 1월 1일 현재 주문 적체를 $4.4 백만 달러로 줄이는 데 도움이 되었습니다. 이는 1년 전 9.4백만 달러에서 감소한 수치입니다. 회사는 현재의 적체가 유통업체가 비축재고를 보충하고 최종 사용자가 송아지 출산 시즌을 앞두고 주문을 잡기 때문에 발생했다는 점에 기인한다고 밝혔습니다.

ImmuCell은 또한 Re-Tain®에 대한 진전을 보고했으며, FDA에 비 관리형 NADA를 제출한 것과 관련된 네 번째 CMC 기술 섹션 제출 및 신속 심사에 대한 논의도 포함되어 있습니다.

ImmuCell (ICCC) a rapporté des résultats préliminaires de ventes solides et non audités pour le quatrième trimestre et l'année entière 2024. La société a atteint des ventes totales de 7,8 millions de dollars au quatrième trimestre 2024, soit une augmentation de 52% par rapport à 5,1 millions de dollars au quatrième trimestre 2023. Les ventes pour l'année entière 2024 ont atteint 26,5 millions de dollars, en hausse de 52% par rapport à 17,5 millions de dollars en 2023.

La production au cours du quatrième trimestre 2024 a atteint 103% de la capacité totale estimée de l'entreprise de 30 millions de dollars par an. Cela a contribué à réduire le backlog des commandes à 4,4 millions de dollars au 1er janvier 2025, en baisse par rapport à 9,4 millions de dollars un an plus tôt. L'entreprise attribue le backlog actuel à une forte demande car les distributeurs reconstituent les stocks de sécurité et les utilisateurs finaux passent des commandes avant la saison de pointe des vêlages.

ImmuCell a également signalé des progrès sur Re-Tain®, avec la récente soumission de son NADA non administratif à la FDA, y compris la quatrième soumission de la section technique CMC et des discussions concernant un examen accéléré.

ImmuCell (ICCC) meldete starke vorläufige, nicht geprüfte Verkaufsresultate für das vierte Quartal und das Gesamtjahr 2024. Das Unternehmen erreichte Gesamtverkäufe von 7,8 Millionen Dollar im vierten Quartal 2024, was einem Anstieg von 52% im Vergleich zu 5,1 Millionen Dollar im vierten Quartal 2023 entspricht. Die Gesamtverkäufe für das Jahr 2024 betrugen 26,5 Millionen Dollar, was einem Anstieg von 52% im Vergleich zu 17,5 Millionen Dollar im Jahr 2023 entspricht.

Die Produktionsausgabe im vierten Quartal 2024 erreichte 103% der geschätzten Gesamtkapazität des Unternehmens von 30 Millionen Dollar pro Jahr. Dies trug dazu bei, den Auftragsbestand zum 1. Januar 2025 auf 4,4 Millionen Dollar zu reduzieren, was einem Rückgang von 9,4 Millionen Dollar im Vorjahr entspricht. Das Unternehmen schreibt den aktuellen Auftragsbestand der starken Nachfrage zu, da die Händler ihre Pufferbestände auffüllen und Endverbraucher Bestellungen im Voraus für die Hochsaison der Kälbergeburten aufgeben.

ImmuCell berichtete auch über Fortschritte bei Re-Tain®, mit der kürzlichen Einreichung seiner Nicht-Administrative NADA bei der FDA, einschließlich der vierten Einreichung des CMC-Technikabschnitts und Gespräche über eine beschleunigte Überprüfung.

Positive
  • 52% revenue growth in Q4 2024 to $7.8 million
  • 52% revenue growth for full year 2024 to $26.5 million
  • Production output exceeding capacity at 103%
  • Significant reduction in order backlog from $9.4M to $4.4M
  • Strong product demand from distributors
Negative
  • Re-Tain® still pending FDA approval
  • Operating at full capacity might limit further growth

Insights

The preliminary Q4 and FY2024 results showcase remarkable growth with $7.8 million in Q4 sales (52% YoY increase) and $26.5 million for the full year 2024 (52% YoY increase). The company's production capacity utilization at 103% of its $30 million annual capacity demonstrates strong operational efficiency. The reduction in order backlog from $9.4 million to $4.4 million indicates improved supply chain management while maintaining robust demand.

The ongoing FDA approval process for Re-Tain® represents a critical catalyst. The recent Non-Administrative NADA filing, including the fourth CMC Technical Section submission and discussions about expedited review, suggests potential near-term commercialization. This product could significantly expand ImmuCell's market opportunity in the dairy sector, particularly given its advantage of no milk discard or meat withhold requirements compared to traditional antibiotics.

For a small-cap company with a market cap of $46.5 million, these results indicate strong market positioning and execution. The 52% growth rate significantly outpaces industry averages and could lead to multiple expansion if sustained.

The dairy and beef cattle health market dynamics strongly favor ImmuCell's growth trajectory. The $4.4 million backlog, while reduced, represents nearly 17% of annual sales, indicating sustained market demand. The timing aligns strategically with the upcoming peak calving season in Q1, suggesting potential continued strong performance.

The company's dual product strategy with First Defense® (current revenue driver) and Re-Tain® (future growth catalyst) positions it well in the animal health sector. The focus on alternatives to traditional antibiotics aligns with increasing regulatory pressure and consumer preference for antibiotic-free dairy products. The successful commercialization of Re-Tain® could unlock significant market share in the subclinical mastitis treatment segment, estimated to affect 20-30% of dairy cows globally.

PORTLAND, Maine, Jan. 09, 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 preliminary, unaudited sales results for the fourth quarter and full year ended December 31, 2024.

Since the first quarter of 2020, the Company has been providing a preliminary look at its unaudited top line results soon after the close of the quarter. The Company expects to continue providing this prompt, preliminary report on product sales until further notice going forward.

Preliminary, Unaudited Total Sales Results:

 20242023$ Increase % Increase
During the Three-Month Periods Ended December 31,$7.8 million$5.1 million$2.7 million52%
     
During the Years Ended December 31,$26.5 million$17.5 million$9.0 million52%


During the three-month period ended December 31, 2024, annualized production output was approximately 103% of the Company’s estimated full capacity of approximately $30 million per year. This production output helped reduce the backlog of orders to approximately $4.4 million as of January 1, 2025 from approximately $9.4 million as of January 1, 2024. The Company believes that the current backlog reflects strong demand as distributors work to replenish their buffer stocks and as end-users place orders in advance of peak calving season during the first quarter.

“We continue to work to achieve FDA approval to commercialize Re-Tain®,” commented Michael F. Brigham, President and CEO of ImmuCell. “In late December, our contract manufacturer submitted its response to inspectional observations pertaining to its facilities. We just filed our Non-Administrative NADA in January, which included our fourth submission of the CMC Technical Section (responding to the minor, non-complex issues from the prior Incomplete Letter) together with All Other Information and Product Labeling. We have been in discussions with the FDA about an expedited review of our filing.”

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) at 9:00 AM ET. 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 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 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 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 


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.


FAQ

What was ImmuCell's (ICCC) revenue growth in Q4 2024?

ImmuCell reported Q4 2024 sales of $7.8 million, representing a 52% increase from $5.1 million in Q4 2023.

How much did ImmuCell (ICCC) reduce its order backlog in 2024?

ImmuCell reduced its order backlog from $9.4 million as of January 1, 2024, to $4.4 million as of January 1, 2025.

What is the current production capacity utilization of ImmuCell (ICCC)?

During Q4 2024, ImmuCell's production output was approximately 103% of its estimated full capacity of $30 million per year.

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

ImmuCell filed its Non-Administrative NADA in January 2025, including the fourth CMC Technical Section submission, and is in discussions with the FDA about an expedited review.

What was ImmuCell's (ICCC) total revenue for full year 2024?

ImmuCell reported total revenue of $26.5 million for full year 2024, a 52% increase from $17.5 million in 2023.

Immucell Corp

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Biotechnology
In Vitro & in Vivo Diagnostic Substances
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United States of America
PORTLAND