ImmuCell Q2 2023 Earnings Call Transcript

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August 11, 2023

There are 2 speakers on the call.

Operator

Good day, and welcome to the ImmuCell Corporation Reports Second Quarter Fiscal Year 2023 Financial Results Conference Call. All participants will be in a listen only mode. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to Joe Doorme with Wytham Partners.

Operator

Please go ahead.

Speaker 1

Thank you. Good morning and welcome. As Betsy indicated, my name Joe Dormain with Witham Partners. We are the Investor Relations consulting firm for ImmuCell. Thank you.

Speaker 1

As I indicated that we will be discussing InuCell's unaudited financial results for the quarter ended June 30, 2023. With us today on the call is Michael Bergin, President and CEO. After the conclusion of today's prepared remarks, we will open the call for questions. Before we begin with prepared remarks, I would like to remind everyone certain statements made by management during this conference call include forward looking statements, which include any statements that refer to future events or expected future events or predictions about steps the company plans to take in the future. These statements are not guarantees of performance and are subject to risks and uncertainties that could cause actual results, outcomes or events to differ materially from those discussed today.

Speaker 1

Additional information regarding forward looking statements and the risks and uncertainties that could impact future results, Outcomes or events is available on the cautionary note regarding forward looking statements or the Safe Harbor statement provided and the quarterly report on Form 10 Q that the company filed last night along with the company's other periodic filings with the Securities and Exchange Commission. Information discussed on today's call speaks only as of today, Friday, August 11, 2023. The company undertakes no obligation to update any information discussed on today's call. Please note that references to certain non GAAP financial measures, which may be made during today's call. The company included definitions of these terms as well as Reconciliations of these figures in the most comparable GAAP financial measures in last night's press release in order to better assist you in understanding its financial performance.

Speaker 1

Now I'd like to turn the call over to Michael Bergman, President and CEO of ImmuCell. Michael? Great. Thanks, Joe, and good morning, everyone. First, with regards to the financial results, last night's press release reports no change to are product sales that were first reported on July 11.

Speaker 1

The press release also provides the full unaudited P and L results and Some unaudited summary balance sheet data. We also filed our Form 10 Q for the quarter ended June 30, 2023 last night. I won't take your time here to review those financial results in detail. LastDay's press This release also includes our non GAAP earnings before income taxes, depreciation and amortization or EBITDA. Please see Page 5 for that.

Speaker 1

You can see a significant swing of $3,400,000 from positive EBITDA of $1,200,000 during the 6 months ended June 30, 2022 to negative EBITDA of $2,200,000 during the 6 months ended June 30, 2023. This negative swing in EBITDA pretty much matches a $3,500,000 increase in our net loss from a loss of $171,000 during the 6 months ended June 30, 2022 to a loss of 3,700,000 during the 6 months ended June 30, 2023. The increase in the net loss was in turn largely caused by the $3,500,000 decrease in gross margin earned From $4,800,000 during the 6 months ended June 30, 2022 to $1,300,000 during the 6 months ended June 30, 2023. So what is going on here? Let me try and speak to that.

Speaker 1

First of all, we are very fortunate to have the support of our partners at Goran Savings Bank and the Finance Authority of Maine through a combined $3,000,000 debt facility that we closed in July. This was very important to our cash flows. 2nd, I would like to point you to a disclosure on Page 30 of the quarterly report under the heading Production Capacity Increase, product contamination and related events in which we reviewed some of the significant challenges we have faced over the last 12 months that contributed to our current financial results. I would like to discuss some of these changes here. So as of July 2022, we have completed almost all the facility expansion work and new equipment installations needed to significantly increase our production capacity.

Speaker 1

However, the most critical piece of new equipment being freeze dryer number 4 was delivered 6 months late by the fabricator. This caused us to lose 6 months to our plan, but by the end of 2022, we have freeze dried number 4 approved for use by the USDA. Just as we began to operate at this higher level of capacity at the beginning of 2023, we were forced to slow down production to remediate a contamination event related to our incoming raw material. At the same time, freeze dryer number 2 stopped operating, requiring a 6 month repair, letting us back to 3 operating freeze dryers. As of early July 2023, we were back to operating 4 Freeze dryers and the contamination event was largely behind us.

Speaker 1

I will speak more about remediation in just a moment. Then during the 2nd week of July 2023, USDA arrived on-site to conduct a routine unannounced inspection, and we were required to divert much of our quality and manufacturing personnel to support this inspection, so that we could promptly submit our Detailed responses to the inspectional observations to the USDA. As we were preparing our responses under the timeline agreed With the USDA, the USDA imposed a voluntary stock distribution and sale, a DSDS order and a hold release on First Defense until 2 of the inspectional observations were resolved. This meant we were prohibited from shipping product beginning of the week of July 24 and continuing until these two inspectional observations were resolved. It's important to note that we were not prohibited from continuing to produce inventory during this period.

Speaker 1

As of August 4, the USDA had verbally rescinded the BSDS and the hold release, allowing us to return to near normal shipping conditions. And since then, that verbal rescind has been updated in writing. Despite this significant diversion of our resources, we anticipate that we will make our 3rd submission of the CMC technical section for RETAIN to the FDA shortly. This submission will be subject to a 6 month review by the FDA. We remain poised and excited to revolutionize the The way that subclinical NASH studies is treated in today's dairy market with a novel alternative to traditional antibiotics.

Speaker 1

As I said, the last 12 months have been very challenging for us for sure. We are working incredibly hard to address these challenges and move forward. Based on our responses, I am optimistic about what we can do in the coming quarters. So let's go back to that contamination comment, I'd like to make an additional comment about the remediation of the contamination events. So we have been driven by data as we resolve this temporary production problem.

Speaker 1

I'd like to explain what I mean by that. All production batches are routinely tested by our quality control team at the beginning, middle and end of the production process. During the 4 month period ended August 4, all three of these standard quality control tests have met specifications 100% of the time. Improvements throughout the production process from the depth of the contamination problem in January are allowing us to come back into full production. We believe that the operational improvements we have implemented will help us run more effectively at higher output level going forward.

Speaker 1

Our goal is to be able to produce about $6,000,000 worth of product per quarter, which would annualize to about 80% of our estimated $30,000,000 full production capacity annually. So lastly, I'd like to I encourage you to review the press release and the quarterly report that we filed last night. Also, please have a look at our Corporate presentation slide deck, I believe it provides a very good summary of our business strategy and objectives as well as our current financial results. An August update was just posted to our website last night. See the Investors section on our website and click on Corporate Presentation or Contact Us for a copy.

Speaker 1

With that said, I'd be happy to take your questions. Let's have Daphne open up lines.

Operator

We will now begin the question and answer session. This concludes our question and answer session. I would like to turn the conference back over to Joe Dormay for any closing remarks.

Speaker 1

We would like to thank you for participating in today's call. We look Forward to talking with you again when we host our Q3 call on or about Tuesday, November 14, 2023. Have a great day.

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Earnings Conference Call
ImmuCell Q2 2023
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