ImmuCell Q2 2025 Earnings Call Summary and Q&A Highlights: Strategic Expansion and FDA Approval Challenges

Earnings Call
Aug 15

[Management View]
ImmuCell's management highlighted key metrics such as a 22% increase in product sales over the trailing twelve months ended June 30, 2025. Strategic priorities include expanding the First Defense product line and pursuing FDA approval for Retain.

[Outlook]
Performance guidance indicates potential near-term sales softening due to the elimination of backlog orders. Future plans involve investigational product use studies for Retain and exploring strategic partnerships for commercialization.

[Financial Performance]
Product sales increased by 22% YoY, driven by backlog elimination and inventory replenishment. Adjusted EBITDA for Q2 2025 was $1.43 million, up from negative $119,000 in Q2 2024. Cash position improved to $6 million from $3.8 million at year-end 2024.

[Q&A Highlights]
Question 1: You noted that second half sales might be down due to working through the backlog. Can you specify the organic growth excluding the backlog sales?
Answer: The backlog at March 31, 2025, was $4 million, which was worked through during Q2. Some orders were canceled, but most were filled. The long-term plan is solid, but we need to get through this temporary bubble.

Question 2: Can you provide an update on Retain, particularly regarding the facility inspection and FDA approval delays?
Answer: ImmuCell has passed inspection without a 483. The CMO for aseptic filling is resolving 43 inspection observations. The timeline for resolution is uncertain, but it is the final hurdle to FDA approval.

Question 3: How much inventory will be expiring in the second half of the year for investigational use?
Answer: All previously built Retain inventory will be used for investigational studies and will not generate revenue. This inventory has already been expensed, so there is no future impact on the P&L.

Question 4: What are the strategic options being pursued for Retain?
Answer: We are looking for financial and marketing support to help with the commercial launch. This could involve partnerships with larger marketing groups to introduce the novel product to the market.

Question 5: Can you comment on the timing of increasing production capacity from $30 million to $40 million in annual revenue?
Answer: The project is on hold, and timing is being evaluated based on cash flow performance. We are optimistic about needing to increase capacity soon but are carefully considering the timing.

Question 6: How will the sales team's renewed focus help the First Defense product line?
Answer: The sales team is now confident in adequate inventory levels and is actively pursuing new customers and regaining lost ones. This shift will help rebuild our reputation and drive sales.

Question 7: Can you discuss the traction for the new format of First Defense, such as spray-dried colostrum?
Answer: We had our first sales in Q2 and will provide more detail in Q3. The new format targets large ranches with calf feed, expanding our market reach.

Question 8: Regarding regaining customers, are you focusing on second-tier distributors or end customers?
Answer: Mostly end customers who had to switch to different products during the supply shortage. We aim to regain their business by ensuring reliable supply.

Question 9: How do you see the frozen colostrum inventory over the next six to twelve months?
Answer: We have a strong network of farms providing colostrum. Managing inventory to prevent a return to backlog is a priority, and we plan to work it down and spray dry as part of our strategy.

Question 10: What are your plans for the beef segment, which is primarily seasonal?
Answer: Beef is important but challenging due to its spread-out nature. We are addressing this with marketing campaigns to reach more customers without extensive on-site visits.

[Sentiment Analysis]
Analysts expressed cautious optimism, focusing on strategic execution and FDA approval challenges. Management maintained a disciplined and proactive tone, emphasizing operational improvements and strategic flexibility.

[Quarterly Comparison]
| Metric | Q2 2025 | Q2 2024 | YoY Change |
|-------------------------|---------------|---------------|--------------|
| Product Sales | $5.1 million | $4.18 million | +22% |
| Adjusted EBITDA | $1.43 million | -$119,000 | N/A |
| Cash Position | $6 million | $3.8 million | +$2.2 million|
| Gross Margin | 44% | 22% | +22% |

[Risks and Concerns]
Potential sales softening due to backlog elimination. FDA approval dependency for Retain, with delays related to third-party CMO inspection issues.

[Final Takeaway]
ImmuCell reported strong financial performance for Q2 2025, driven by backlog elimination and inventory replenishment. Management is focused on expanding the First Defense product line and navigating FDA approval challenges for Retain. While near-term sales may soften, strategic partnerships and investigational studies are expected to support long-term growth. Investors should monitor FDA approval progress and strategic developments for Retain.

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