ImmuCell Corporation

Good morning, and welcome to MSL Corporation Report's third quarter fiscal year 2022 financial results conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. Please note, this event is being recorded. I would now like to turn the conference over to Joe Diaz at Liftham Partners. Please go ahead.

Thank you, Chad. Good morning and welcome to everyone. As Chad indicated, my name is Joe Diaz with Liftham Partners. We're the investor relations consulting firm for Emucell. I thank all of you for joining us today to discuss the unaudited financial results for the third quarter, which ended September 30, 2022. I would like to preface this discussion today 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 that are subject to risks and uncertainties that could cause actual results to differ materially from those discussed today. Additional information regarding these risks and uncertainties is available under the cautionary note regarding forward-looking statements or better known as the safe harbor statement provided with last night's press release and with the company's quarterly report on 10Q for the three-month and the nine-month periods ending September 30, 2022, along with the company's other periodic filings with the SEC. With that said, let me turn the call over to Michael Brigham, President and CEO of IndyCell Corporation, after which we will open the call for your questions. Michael.

Okay, great. Thanks, Joe. And good morning, everyone. So a summary of the third quarter and year-to-date financial results are now available to you from last night's press release. And the details are available from the Form 10-Q for the quarter ended September 30, 2022 that we also filed last night. We did file this Form 10-Q about five business days late to allow time to restate our first and second quarter filings with the SEC. The restatements were made to reflect a non-cash accrual of deferred compensation expense consisting of earned and unused paid time off during the first quarter of 2022. This change increased our administrative expenses and accrued expenses by approximately $222,000, once again, with no impact on our cash position or on our product sales. As you may know, on October 5th, we issued a press release covering our preliminary top line sales results. We have been making these optional announcements to give investors a very timely look at product sales, which I believe is the most critical measure of our operations and financial performance early in the reporting period. I have no changes to that previous disclosure. Again, sales were down about $350,000 during the three-month period ended September 30, 2022, compared to prior year. But sales were up 24% or $935,000 over sales during the second quarter of 2022. As we look at the longer periods of time, sales were up 6% or $858,000 and 15% or $2.56 million during the nine-month and 12-month periods end of September 30, 2022, respectively, compared to the same periods during the prior year. We are experiencing a bit of a bumpy road as we exit from a long period of short product supply to our emerging new state with expanded and still expanding production capacity. Prior to our introduction of the newest extension of the First Defense product line in late 2017 and its popularity with our customers, namely Tri-Shield First Defense, annual production capacity of about 16.5 million was adequate to cover sales promptly without an order backlog. I should note that the capacity estimates that I mentioned on this call vary based on biological and process yields, product format mix, selling price, and other factors. Beginning in 2018, our world changed for the better with the introduction of TriShield. We have been investing millions of dollars in capital expenditures to increase our production capacity. This kind of significant investment in real estate, manpower, and equipment does take time despite all the urgency and energy our team puts into it. This transition from backlog to buffer stock was complicated further during the second quarter by a material disruption in the supply of the needed plastic syringes used in our gel product formats. We have solved that supply disruption challenge. Recently, we experienced some contamination events in our production process around the end of the third quarter of 2022. This resulted in a write-off of approximately $412,000 and has pushed us back into a backlog situation. We believe that we have addressed these challenges going forward. Installation of two critical pieces of equipment needed to increase our production capacity are on track to be operational by the end of the year. Investments being completed through the end of this year should bring our annual production capacity to the stated goal of $35 million per year at 100% operating levels going forward into 2023. This is what we need to increase our production capacity and solve the backlog going into 2023. A new investment that is referred to as Project H in our SEC filings represents an investment in building modifications and equipment to further increase our annual first defense production capacity from the 35 million level to approximately 47 million during the second half of 2024 with options for further expansion. Project H also provides improved facilities for powder milling and much needed additional cold storage and warehouse space. In contrast to past capacity expansion investments that could not possibly be completed soon enough, The timeline for this investment is much more reasonable for all involved, including our employees, contractors, and equipment fabricators. The levels of production output that I just mentioned require running equipment and staff at nearly 100% of capacity. We have been running hard near to that level over the last couple of years in order to fill the backlog of orders. This opens us up to product contaminations and forces us to defer preventive maintenance of equipment while subjecting us to more disruptive emergency maintenance. One of the objectives of Project H is to create a more sustainable production schedule. For example, by running at 80% of maximum capacity, Project H could increase our annual production output from approximately 27.7 million at the end of this year to approximately 37.3 million during the second half of 2024. EBITDA, which is an important non-GAAP financial measure for us, given the high level of non-cash depreciation that we carry, decreased to approximately $1.3 million during the nine-month period end of September 30, 2022, from almost $2 million during the nine-month period end of September 30, 2021. This non-GAAP financial measure should be considered in context with our statement of cash flows that is presented in accordance with GAAP. Let's look at our balance sheet. Cash decreased to $8.8 million at September 30, 2022 from $10.2 million at December 31, 2021. Networking capital decreased by just $12,000 to $3.7 million at September 30, 2022 compared to December 31, 2021. Stockholders' equity decreased to just under $32 million at September 30, 2022, from 32.6 million at December 31, 2021. All this has been going on while we continue to work on and fund the development required to achieve FDA approval of Retain. Our product development objective is to demonstrate that our polypeptide antimicrobial, Niacin A, can play a productive role in the treatment of subclinical mastitis in today's dairy industry. offering an effective alternative to traditional antibiotics. Because label requirements of all intramammary mastitis drugs on the market today require that milk be discarded and that meat be withheld during treatment and for a period of time thereafter, it is common practice to not treat sick cows that are still producing saleable milk. Retain provides an animal welfare benefit by removing this economic disincentive to treating subclinical mastitis and allowing sick cows to be treated without the milk discard and meat withhold penalties. In addition to improved animal welfare, RETAIN enhances food safety and sustainability by utilizing niacin, which is not used in human medicine. This is important because the overuse of traditional antibiotics, including in food production animals, is believed to create antibiotic resistance in human consumers, which is an ongoing public health concern. So we are preparing all the data required to make our third submission of the CMC technical section, approval of which is required to market retain. This submission would be subject to a six-month review by the FDA. We are on track to make this submission during the first quarter of 2023, but the exact timing within the quarter is not presently known. We remain poised and excited to revolutionize the way that subclinical mastitis is treated Mastitis is a disease that causes about $2 billion in economic harm to the US dairy industry per year. In conclusion, I encourage you to review the press release and the quarterly report on Form 10-Q 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. A November update was just posted to our website last night. See the investors section of our website and click on corporate presentation or contact us for a copy. With that said, I'll be happy to take your questions. Let's have Chad open up the lines, please.

Thank you, sir. We will now begin our question and answer session. To ask a question, you may press star then one on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. Again, pressing star then one will allow you to ask a question. At this time, we will pause momentarily to assemble our roster. And again, pressing star then one will allow you to ask a question.

It looks like we've got a couple of people in the queue.

Thank you. And first question will come from Jim Barrett with Barrett Investments. Please go ahead.

Good morning, Joe and Michael. Michael, I may have missed it, but are the product challenges that you experienced in Q3 Have they been solved and can you explain what happened? Was it human error? Was there some other factor involved? And if it has not been solved, when would you expect it to be largely behind the company?

Yeah, thanks. That's fair, Jim. So solved, you know, when you're running a biological manufacturing process, I think you're always subject to contamination. I'd hesitate to say solved, like permanently, because it can come around. But what we're very comfortable with is we haven't seen a contamination since these third quarter events. So I think some of the improvements we put in place are working. And we're proceeding, you know, well since then. These events were kind of bunched together. And, you know, looking for a smoking gun, I don't really have one. I have a list. And we've just... implemented a lot of procedures that should, and so far, have helped us avoid further contaminations. And as I mentioned in my comments, I really think it's largely the result of just pushing people and pushing equipment and pushing the process too hard. And this is what we avoid if we move from, you know, operating equipment at 100% to push it down, you know, a bigger capacity to get run at 80%. And do all the right things with preventive maintenance and cleanings and just tightening up the process and the controls. So, so far so good. Extremely painful event, but so far behind us.

And it may be in the queue, but what is the size of your current backlog relative to a year ago or however you measure it?

Yeah. Probably the best answer is what we did put in the queue is our best projection of what we think will be around a year end. And we think it may be around 900,000 at year end. But again, with this new capacity coming on here in the fourth quarter, we just walk into the busy peak season first quarter with, as our VP of sales likes to say, it's not a fire hose, it's a fire brigade. And we just crank at that higher level to turn that around pretty quickly. But yeah, short answer, it's subject to sales and new product releases and actual figures. But we're thinking it's going to be up to around $900,000 at year end.

And then finally, could you update us on your planned capital spending for both this year and 2023?

yeah um now there's a lot of detail i i in that in the queue on that i just spelled out project h to a through h um but we are completing uh you know all the current projects and then this h is the new one that will take us to get this next level over but you know for for for the end of 24. so i would refer you and maybe beth help me here on the page um

Yeah, I will read the 10-2.

Yeah, just, you know, but specifically to your question, it's around page 27 where we just detail each project. And I think the summary you're looking for, which maybe I'll just read to the benefit of others, is, you know, when we, you know, we disclose our cash, obviously, and we set aside about $5.7 million to complete these projects, and that leaves about $3.1 million for, you know, go forward.

I see.

Well, thank you very much. I appreciate the answers.

Yeah, thanks, Jim.

And once again, if you would like to ask a question, please press star and one. The next question is from Charles Scherhammer from Scherhammers. Please go ahead.

Hi, Michael. Thanks for all your hard work. I really appreciate that. My question is towards this rising interest rate environment. Could you opine on how the company is positioned going into this higher rate?

Yeah. I think this is a good place to brag a little bit. I really like our debt structure. Just before interest rates started going up, we were able to lock everything in, and we're at a blended rate of about 3.56. So most of our debt is right around 3.5. We do have a couple of state of Maine loans at 5%. Again, blended rate, 3.56, and it's fixed.

And what's the duration on that? Approximately.

Yeah. I mean, there's four different instruments, and they have different, between mortgage and clip and loan, different maturities. But I'm going to grab a footnote 10 and kind of refer you to the details there. But on page 13, 14 of the queue, we give... the maturity schedule and the breakdown of the different instruments precisely.

Perfect. All right. Great. All right. Thank you very much. Thanks, Charles. Appreciate it.

Thank you. And once again, if you would like to ask a question, please press star one. Ladies and gentlemen, this concludes our question and answer session. I would like to turn the conference back over to Joe Diaz for any closing remarks.

Thank you, Chad. And again, thanks to all of you for participating in today's call. We look forward to talking with you again to review the results for fiscal year 2022 during the latter part of February 2023. Hope you have a great holiday season, everyone. Thank you. Have a great day.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.