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ImmuCell Announces Preliminary, Unaudited Sales Results for Q2 2024

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ImmuCell (Nasdaq: ICCC) has announced preliminary, unaudited sales results for Q2 2024. The company reported a 55% increase in sales to $5.47 million for the three-month period ended June 30, 2024, compared to $3.53 million in the same period of 2023. For the first half of 2024, sales rose by 82% to $12.73 million, and for the twelve-month period, sales increased by 48% to $23.22 million. The company's production output was between 74% and 85% of its full capacity. Additionally, ImmuCell is working towards FDA approval for Re-Tain®, with submission expected after resolving inspectional observations. A conference call is scheduled for August 14, 2024, to discuss these results further.

Positive
  • 55% increase in Q2 2024 sales to $5.47 million.
  • 82% rise in sales for the first half of 2024 to $12.73 million.
  • 48% growth in twelve-month sales to $23.22 million.
  • Production output between 74% and 85% of full capacity.
  • Backlog of orders aggregating approximately $8.93 million.
Negative
  • None.

Insights

ImmuCell's preliminary sales results for Q2 2024 show a significant bump in revenue, reflecting a 55% increase in sales to $5.47 million compared to Q2 2023. For the six-month period, sales jumped 82% to $12.73 million. This kind of growth suggests that the company’s products are gaining strong market traction. The company also has a notable backlog of orders amounting to $8.93 million as of June 30, 2024, indicating robust future demand.

However, it’s important to consider the capacity constraints. The company produced at about 77% of its full capacity over the past year and plans to increase to 95% for the rest of 2024. This indicates a potential bottleneck if demand continues to rise and production cannot scale accordingly. Investors should keep an eye on whether the company can meet its production goals, as falling short could impact future growth.

Short-term, the revenue boost and backlog are positive indicators. Long-term, successful scaling of production and managing capacity constraints will be crucial. Further, the mention of future FDA approvals for Re-Tain® introduces another variable that could significantly impact future financial performance.

From a market perspective, ImmuCell operates in the animal health industry, focusing on dairy and beef cattle. The strong sales growth reflects growing acceptance of their products in this niche market, likely driven by the efficacy and practicality of offerings like First Defense®.

However, the company's focus on scaling to meet demand and the potential FDA approval for Re-Tain®—a treatment for subclinical mastitis—presents both opportunities and risks. If FDA approval is granted, Re-Tain® could disrupt the market for veterinary treatments, given its unique position of not requiring milk discard or meat withhold, which is significant for dairy production efficiency.

The ongoing development and commercialization of new products add to the growth story. Investors should watch for updates on the FDA approval process, as this could dramatically alter ImmuCell's market position.

The mention of ongoing efforts to commercialize Re-Tain® is particularly noteworthy. Re-Tain® is positioned to address subclinical mastitis, a common and costly issue in dairy herds, without the need for milk discard or meat withhold. This gives it a potential market advantage over traditional antibiotics that have withholding periods affecting milk and meat sales.

However, the success heavily depends on FDA approval. The company plans to resolve inspectional observations with its contract manufacturer and expects a review period of less than 180 days post-submission. This timeline means that investors should monitor FDA communications and approval status updates closely, as these will be critical to understanding the potential market entry and impact of Re-Tain®.

While waiting for approval, it’s essential to recognize that delays or negative inspection outcomes could hinder progress. Thus, while the potential is high, there is also a significant regulatory risk involved.

PORTLAND, Maine, July 09, 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 preliminary, unaudited sales results for the second quarter of 2024, which ended June 30, 2024.

Preliminary, Unaudited Total Sales Results:  
  2024 2023 $ Increase  % Increase
During the Three-Month Periods Ended June 30,$5.47 million$3.53 million$1.94 million55%
     
During the Six-Month Periods Ended June 30,$12.73 million$6.98 million$5.75 million82%
     
During the Twelve-Month Periods Ended June 30,$23.22 million$15.69 million$7.54 million48%
     

During the three-, six- and twelve-month periods ended June 30, 2024, annualized production output was approximately 74%, 85% and 77%, respectively, of the Company’s estimated full capacity of $30 million per year. As of June 30, 2024, the backlog of orders aggregated approximately $8.93 million.

“We plan to push our production processes aggressively during the second half of 2024 with the goal of producing an additional $14 million worth of product, which would amount to approximately 95% of our estimated full capacity for that period,” commented Michael F. Brigham, President and CEO of ImmuCell. “If we are able to achieve this goal, we will have produced approximately 90% of our estimated full capacity for the year and created significant sales growth over the year ended December 31, 2023.”

“In addition, we continue to work to achieve FDA approval to commercialize Re-Tain®,” Mr. Brigham concluded. “We plan to provide an update when we have made our fourth submission of the CMC Technical Section. We anticipate making this submission shortly after the inspectional observations at our contract manufacturer are resolved to the satisfaction of the FDA, and we expect less than a 180-day review of the CMC by the FDA after that.”

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 provide this prompt, preliminary report on product sales until further notice going forward.

Conference Call:
The Company is planning to host a conference call on Wednesday, August 14, 2024 at 9:00 AM ET to discuss the unaudited financial results for the quarter ended June 30, 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 August 21, 2024 at (877) 344-7529 (toll free) or (412) 317-0088 (international), utilizing replay access code #3744296. 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 on August 13, 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
   

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 impacts of backlogs on customer relationships; 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; 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 were ImmuCell's unaudited sales results for Q2 2024?

ImmuCell reported a preliminary, unaudited sales increase of 55% to $5.47 million for Q2 2024, compared to $3.53 million in Q2 2023.

How did ImmuCell's sales perform in the first half of 2024?

Sales for the first half of 2024 rose by 82% to $12.73 million, compared to $6.98 million for the same period in 2023.

What is the status of ImmuCell's FDA approval for Re-Tain®?

ImmuCell is working towards FDA approval for Re-Tain® and plans to submit the fourth CMC Technical Section shortly after resolving inspectional observations at their contract manufacturer.

When is ImmuCell's conference call to discuss Q2 2024 results?

ImmuCell is scheduled to host a conference call on August 14, 2024, at 9:00 AM ET to discuss the Q2 2024 results.

What is ImmuCell's production output capacity as of June 30, 2024?

As of June 30, 2024, ImmuCell's annualized production output was approximately 74%, 85%, and 77% for the three-, six-, and twelve-month periods, respectively, of the estimated full capacity of $30 million per year.

Immucell Corp

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