Good morning, everyone and welcome to the ImmuCell Corporation reports First Quarter of Fiscal Year 2021 Financial Results Conference Call. [Operator Instructions] Please also note today’s event is being recorded. At this time, I would like to turn the conference call over to Joe Diaz with Lytham Partners. Sir, please go ahead..

Thank you, Jamie. Good morning and welcome to all. As Jamie indicated, my name is Joe Diaz, I am with Lytham Partners. We are the Investor Relations consulting firm for ImmuCell. Again, we thank all of you for joining us today to discuss the unaudited financial results for the first quarter of 2021.

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 that are not in the Safe Harbor statement provided in last night’s press release and the company’s quarterly report on Form 10-Q.

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?.

one, the use of proceeds from April’s equity raise; two, our cash flows; and three, the road to regulatory approval of Re-Tain. First, as you may know, we raised $4,250,000 in new equity at $8.25 per share last month. That was a straight common stock deal, no warrants, no converts, very low issuance costs.

This funding together with some other available cash allows us to aggressively take on four new important growth investments aggregating about $5.4 million.

We are investing to scale up and upgrade our vaccine production capacity, expand and improve our classroom collection capabilities and logistics further increase our annual production capacity for First Defense from the new level of $23 million to about $30 million and for build inventory levels as we come out of backlog and prepare for peak selling season during the first quarter of 2022.

Full details about these investments and other capital expenditure projects that we are working on can be found in our quarterly report, in the MD&A section under liquidity and capital resources, around Pages 25 to 26.

I appreciate the confidence that these new investors have demonstrated in our business and I believe we are putting this money to very productive use to grow our business for the benefit of all stockholders. So secondly, our cash flows. Driven primarily by large product development expenses to bring Re-Tain to market, we continue to report a net loss.

However, I think we should focus on our cash flows more than our GAAP net loss at this stage in our development. Page 4 of last night’s press release provides a look at the impact of certain non-cash expenses on our financial results.

You can see that we continue to report positive EBITDA, which I believe is the most relevant to tracking our bottom line performance at this stage. But the most important measure is the statement of cash flows on Page 4 of our quarterly report. Third and lastly, the road to regulatory approval of Re-Tain.

It has been a long and then it has been an expensive road, but we are nearing completion of the work required to achieve FDA approval of this novel sub-clinical mastitis treatment for lactating dairy cows without a milk discard or meat withhold. During the first quarter, we submitted the last five technical sections required for FDA approval.

This kind of submission is subject to a 6-month review by the FDA. That puts us at a huge fork in the road during the third quarter of this year. If the FDA has questions for us, we could be required to respond through another submission, which would be subject to an additional 6-month review.

We do not anticipate that an additional submission would be required after that. Therefore, we are making plans for a mass market launch during the second quarter of 2022, while also being prepared to flex to an initial limited launch plan around the end of this year, in the event the approval comes through in response to our first submission.

Re-Tain puts a second horse in the race for us as we strive to keep growing our total product sales. So 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 and May update was just posted to our website last night.

I believe it provides a very good summary of our business strategy and objectives as well as our current financial results. You would see the Investors Section on our website and click on Corporate Presentation. With that said, I will be happy to take your questions. Let’s have the operator open up the lines. Thanks, Jamie..

[Operator Instructions] Our first question today comes from Sam Rebotsky from SER Asset Management. Please go ahead with your question..

Good morning, Michael.

Tell me how many employees do you have now? And how many do you expect to have when it – in June and what’s – where are we on that?.

Right? Yes, so the Q disclose is right around 54 FTEs. We have got about 6 part times. So 53, 54 currently, that’s going to go right up to 60 and on above up to around 70, when we are fully loaded and launching Re-Tain into next year. So, I see 54 going to 60, quick and 70 over the next year..

Okay.

And as far is the June 30, we are comfortable with that date in being ready to start manufacturing, or what do we need to do?.

Well, we are at the end of the process. So, we are getting more and more comfortable as each objective is achieved and completed. But it’s not done until the USDA approves it. So the final part of this, I think I kind of refer to that in the gross margin discussion, there are some of these costs already incurred.

So, the new building over 175, or we do our finished packaging, and formulation and filling of product, now that’s already up and running. And it’s a question of just finishing up the work here at 56 Evergreen, and that is installing tanks. Tanks are ordered. Tanks are fabricated. Tanks are being installed. So, I feel pretty good about that timeline.

It’s a beautiful space. All the facility renovations are done, just poured the floor, the epoxy coating on the floor this week it’s gorgeous space. So, it’s [indiscernible] USDA and I feel good about June 30..

Okay. And now as far as the Re-Tain, we have submitted that to the FDA.

And have we gotten any indication how the FDA is operating under COVID? And is it six months or what is the timeframe?.

Yes, the timeframe, pre-COVID. And as far as we know, in COVID is six months. So, we have seen no indication that that would be changed. So, we do still expect 1Q to go to 3Q on that critical submission that six months review. The FDA just in the last few days did publish some information on remote inspections. So, that’s obviously relevant to us.

We are expecting an inspection of our facility. And it looks like that may be remote. I have got a whole Zoom setup. And that’s what they have told the industry to be prepared for. So, we are Zoom in ready..

Alright, and with the backlog, hopefully, when did – how do we look at reducing the backlog, it’s June 30, you will hopefully have everything up and running.

When do we – is the backlog continue to increase? And what do we do relative to reducing it?.

Yes. Well, right 3.1 is a huge number. So, the backlog goes up and down. We do see orders being cancelled from time-to-time. Some distributors just don’t want open POS on their books for an extended period. Others place more orders looking to get in the queue.

So, what we are doing here in the second quarter is taking advantage of as much capacity as we can push in the second quarter in advance of the full completion of the project and then going into third quarter just run straight out. Will this run until we catch it. And that’s our goal somewhere there in the third quarter.

Get back to the point where sales is on the road, knowing that inventory is available to ship when the appeal is placed. Get this backlog stress out and behind all of us..

Well, that sounds very good. Good luck, Michael..

Thanks, Sam. I appreciate it. Good to hear from you..

[Operator Instructions].

Okay, well, the queue starts filling up, Michael, I did have a question about the facility, the capacity and the timing of it coming online and also the FDA approval process of the actual facility.

Can you give us a little color on a couple of those things?.

Yes. So, I mentioned it Sam, I do feel really good about June 30. Everything is falling in place, we really have, as long as this 18 month project has been since we started at the beginning of 2020. It has stayed to our timeline and to our dollar budget.

So yes, the second duplication of our cheese line, in other words, increasing our liquids, processing 100% is really the last step here. And those tanks are going in as we speak. And then that’s somewhere there is a little flex here, but we think it’s a 2 or 3-week process. We are really tight with the USDA. They know what’s coming.

But we have to allow about 2 to 3 weeks for them to do their review and just make sure everything checks. So on the First Defense side, just I feel good, it’s right in front of us here.

And then Re-Tain again, that is a – I think it’s a ‘21 objective to complete the regulatory and ‘22 is when we launch and it’s just a question of what happens here with this first submission if they like it and don’t have questions.

We move on to the administrative review, which is the end of the process, labeling and all that freedom of information labeling and all that. And if they have questions at least know what they want to see we answer them and submit for, that’s the one that has another 6 months.

So, I mean both of these objectives, which are so critical for our business, are right in front of us, get out of backlog and get approval and then launch Re-Tain. The next 12 months are going to be, I think very exciting..

Thank you, Michael..

And our next question comes from Jenifer Taylor from MAC Funds. Please go ahead with your question..

Hi, good morning. It looks like and sounds like you are making really good progress. And bear with me, I am not completely current on sort of what the last characterization has been in terms of funding going out sort of over the next year or two.

I would imagine the the recent funding was sort of viewed as a bridge to get you through what is hopefully a near-term FDA approval.

But could you interest in a couple of words characterize publicly what you have said on how far this funding would get you and what you would look to do strategically longer term?.

Yes, thanks, Jenifer. Very fair. I would also – first I guess refer you to the Q where I really answer that question in a lot of detail, because it’s an important question and I want to get that answer out there exactly where we are spending that money.

So, project by project, the $5.4 million, really exciting investment, so the First Defense capacity was already budgeted and sort of cash funded. What’s new is advancing the pre-marketing launch expenses for Re-Tain and taking First Defense to the higher level.

So, these are – this new money just allows us to be a little more aggressive, move a little quicker on next level of First Defense and then completing and pre-launch marketing on Re-Tain.

I don’t know does that help? Does that a full answer, Jenifer?.

You know what forgive me not having read the Q yet. I just was wondering with that raise whether or not if this would extend your – I mean, I realize you have gotten you need to build inventory, you are driving the top line.

And I just didn’t know if you had characterized whether or not beyond sort of EBITDA positive if you would need to raise additional capital for a more formal launch?.

Yes, no, I mean, that’s a lot of detail and a filing that just got out last night. I didn’t mean to assume you have read it, I just – it was probably too much detail for me to talk on this call. So, it’s there for a backup right.

It is there for support when you get a rainy day or you get insomnia in the middle of the night? But I think they – I know I really understand that your question, what we are looking at is, I mean, the next big thing we would need to do, the next big use of capital for me, so that would be related to Re-Tain post-approval.

So Re-Tain launches with a $10 million capacity, I would love to be in a situation where we could look out and see that $10 million is not going to be enough and that’s sort of a new era and a new challenge and it’s out in front of us.

So, we do – I think to be specific, we do not need more capital to bring our capacity on First Defense to $30 million and we do not need more capital to both launch and initiate sales of Re-Tain..

Perfect, perfect. That’s great. Thank you..

Great..

[Operator Instructions] Our next question is a follow-up from Sam Rebotsky from SER Asset Management. Please go ahead with your follow-up..

Yes, Michael, you answered my follow-up and I guess the question really is did we need any more money after this and evidently, you did and good luck.

You have enough capital?.

Right. This last raise was just so well supported by the [indiscernible] family and some other key investors.

And just I don’t know if I can consider it optional, but it did put together, it did allow us to launch some really important growth investments, but I separate that from that Re-Tain production capacity north of $10 million, different topics, different times, different needs..

Sound good..

Good, Sam. Thanks..

Yes, sure..

And ladies and gentlemen, with that, we will conclude today’s question-and-answer session. I’d like to turn the floor back over to Joe Diaz for any closing remarks..

Hey, Joe, are you on mute? No worries..

I think I am on mute..

Okay. Wrap us up..

Thank you for participating in today’s call. We look forward to talking with you again to review the results for the second quarter of 2021, not on mute around the second week of August of 2021. Have a great weekend. Stay safe and well. Thank you again. Have a great day..

Ladies and gentlemen, with that, we will conclude today’s conference call with you. Thank you for attending today’s presentation. You may now disconnect your lines..