Good day, everyone, and welcome to the ImmuCell Corporation's Third Quarter 2023 Financial Results Conference Call. [Operator Instructions] Please note this event is being recorded. And now I would like to turn the conference over to Joe Diaz. Please go ahead..

Thank you, Marliese. Good morning, and welcome, everyone. As Marliese indicated, my name is Joe Diaz. I'm with Lytham Partners. We are the Investor Relations consulting firm for ImmuCell. Thank all of you for joining us today to discuss the unaudited financial results for the quarter ended September 30, 2023.

I'd like to preface today's discussion with a caution regarding forward-looking statements.

Listeners are reminded that statements made by management during the course of this call include forward-looking statements, which include any statement that refers to the future events or expected future results 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.

Additional information regarding forward-looking statements and the risks and uncertainties that could impact future results, outcomes or events is available under the cautionary note regarding forward-looking statements or the safe harbor statement provided in the quarterly report on Form 10-Q that the company filed last night, along with the company's other periodic filings with the SEC.

Information discussed on today's call speaks only as of today, Tuesday, November 14, 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 may be made during today's call.

The company included definitions of these terms as well as reconciliations of these figures to the most comparable GAAP financial measures in last night's press release in order to better assist you in understanding its financial performance.

With that said, let me turn the call over to Michael Brigham, President and CEO of ImmuCell Corporation, after which we will open the call for your questions.

Michael?.

Okay. Thanks, Joe, and good morning, everyone. First, with regards to the financial results, last night's press release reports no change to our product sales results that were first reported on October 5th. The press release also provides the full unaudited P&L results and some unaudited summary balance sheet data.

We also filed our Form 10-Q for the quarter ended September 30, 2023, last night. I won't take our time here to review those financial results in great detail. Last night's press release also includes our non-GAAP earnings before income taxes, depreciation and amortization or EBITDA. Please see Page 5 of the press release.

You can see a significant swing of negative $3.6 million from positive EBITDA of $1.3 million during the 9 months ended September 30, 2022, to negative EBITDA of $2.3 million during the 9 months ended September 30, 2023.

This negative swing in EBITDA pretty much matches a $3.8 million increase in our net loss from $826,000 during the 9 months ended September 30, '22 to $4.6 million during the 9 months ended September 30, '23.

The increase in the net loss was, in turn, largely caused by the $4 million decrease in gross margin, earned from $6.7 million during the 9 months ended September 30, '22 to $2.6 million during the 9 months ended September 30, '23.

In response to this loss in cash, we took on more bank debt in July and have cut some discretionary spending and frozen several planned capital expenditure projects for the time being. All of this is unfortunate, but necessary. We are focused intensely on working our way out of this tight situation by increasing production and sales.

To be successful, we must avoid future significant contamination events and equipment breakdowns. So what is going on here? Let me try to speak to that.

I'd like to point you to a disclosure being on Page 29 of our quarterly report or Page 31 of the [indiscernible] version that's filed with the SEC under the heading production capacity increase, production contamination and related events in which we review some of the significant challenges we have faced over the last 12 months that contributed to our current financial results.

So after much work and some significant delays, by the end of 2022, we had completed all the facility improvements and the new equipment installations including freeze dryer #4 that are necessary to increase our estimated full production capacity to approximately $30 million per year.

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 contamination event related to our incoming raw material. At the very same time, freeze dryer #2 stopped operating, requiring a 6-month repair, dating us back to 3 operating freeze drivers.

As of early July '23, we were back to operating 4 freeze dryers, and we now believe these contamination events are largely but not fully behind us. Finished goods produced increased steadily from approximately $3.3 million to $4 million and further to $5.3 million during the first, second and third quarters of 2023, respectively.

Our goal is to produce product with an estimated sales value of approximately $6 million per quarter, which would annualize to about 80% of our estimated full production capacity of approximately $30 million. Our third quarter production was approximately 89% of our quarterly objective.

We have been driven by data as we resolve this temporary production problem.

All production batches are routinely tested by our quality control team at the beginning, middle and end of the production process, improvements throughout the production process from the depth of the contamination problem in January, allowing us to come back into full production.

We believe that the operational improvements we have implemented will help us run more effectively at a higher output level going forward. Despite this significant diversion of our resources, we made our third submission of the CMC Technical Section for retain to the FDA in August. This type of submission is subject to a 6-month review by the FDA.

As disclosed on Page 35 of our quarterly report or Page 37 of the [indiscernible] version as filed with the SEC, the FDA notified us in late October that they have refused to review our August submission because of a misunderstanding about where and by whom, we intend to have our drug product formulated and filled.

The FDA thought our plan was to bring those services in-house, which we might do down the road post approval rather than to continue with our contract manufacturer, which is still our current plan. In response to this notification from the FDA, we refiled our submission in November.

We are in communication with the FDA to resolve this unfortunate miscommunication. But if we fail to reach agreement, the expected response date from their review could be delayed past February 2024, which is 6 months from the August submission date to as late as May 2024, which is 6 months from the November resubmission date.

Regardless, we remain poised and excited to revolutionize the way that subclinical mastitis is treated in today's dairy market with a novel alternative to traditional antibiotics with zero milk discard and zero meat withhold claims. As I said, the last 12 months have been very challenging for us for sure.

We have worked incredibly hard to address these challenges and move forward. Based on our responses and progress, I'm optimistic about what we can do in the coming quarters. Lastly, I encourage you to review the press release and the quarterly report that we filed last night. Please also have a look at our corporate presentation slide deck.

I believe it provides a very good summary of our business strategy and our objectives as well as our current financial results. A November update was just posted to our website last night. You could see the Investors Section of our website and click on Corporate Presentation or Contact Us for a copy.

With that said, I will be happy to take your questions. Let's have Marliese open up the lines..

Operator:.

Thank you, Marliese, and thanks to all of you for participating in today's call. We look forward to talking with you again to review the results for the full year ended on December 31, 2023, sometime around late February 2024. Again, thanks for your time. Have a great day..

And the conference has now concluded. Thank you so much for attending today's presentation. You may now disconnect..