ImmuCell Corporation (ICCC) Q2 2015 Earnings Report, Transcript and Summary

Good afternoon everyone and welcome to ImmuCell Corporation second quarter of fiscal year 2015 financial results conference call. All participants will be in a listen only mode. [Operator Instructions] Please also note that today’s event is being recorded. At this time I’d like to turn the conference call over to Mr. Joe Diaz with Lytham Partners. Sir, please go ahead.

Thank you, Jamie and thank all of you for joining us today to review the financial results of ImmuCell Corporation for the second quarter of fiscal year 2015 which ended on June 30, 2015. As the conference call operator indicated, my name is Joe Diaz. I'm with Lytham Partners. We are the investor relations consulting firm for ImmuCell. With us on the call representing the company today is Michael Brigham, President and Chief Executive Officer. At the conclusion of today's prepared remarks, we will open the call for a question-and-answer session. If anyone participating on today's call does not have a full text of today's press release or Form 10-Q, you can retrieve them from the company's website at immucell.com or through various financial sites on the Internet. Before we begin with prepared remarks, we submit for the record the following Safe Harbor statement. Statements made by management of ImmuCell during the course of this conference call that are not historical facts are considered to be forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides a Safe Harbor for such forward-looking statements. Words such as believe, expect, anticipate, estimate, will and other similar words or statements of expectation identify forward-looking statements. Such statements involve risks and uncertainties including but not limited to those risks and uncertainties detailed from time to time in filings the company submits to the Securities and Exchange Commission, including its quarterly reports on Form 10-Q, its annual reports on Form 10-K and its current reports on Form 8K. Investors are cautioned that forward-looking statements made during the course of this conference call are based on management's current expectations and involve risks and uncertainties that could cause actual results to differ materially from the statements made. The company disclaims any obligation to update forward-looking statements. A more complete Safe Harbor statement was attached on today's press release and on the one announcing the conference call today as well as on Form 10-Q. With that, let me turn the call over to Michael Brigham, President and CEO of ImmuCell Corporation. Michael?

Thank you, Joe, and thanks to all of you for participating on today's call. All of us at ImmuCell greatly appreciate your time and interest. I have a few prepared remarks and observations before turning to the Q&A. In my opinion, we had a great second quarter and first half of 2015. We feel that our business is headed in the right direction. As you may know, we provide a significant amount of detail about the company and our financial results in our SEC filings, I am not going to use my time with you here today to simply read what we've already written but I do want to touch on 5 important highlights. First and perhaps most importantly, we continued to experience strong sales growth. In the second quarter ended June 30, ‘15 the quarterly sales were up 27% up to $1.96 million. The year-to-date sales through June 30, total sales were up 40% to $5.06 million. During the 12-month period ended June 30, total product sales increased by 41% or $2.62 million to $9.04 million in comparison to $6.42 million during the same period ended June 30, 2014. This trailing 12-month sales figure of $9.04 million compares favorably to just under $7.6 million for the year ended December 31, 2014. Clearly First Defense is creating this sales growth. First Defense comprises 94% of our total product sales during the six-month period ended June 30, ’15, it was 90% of total product sales for the same six-month period ended June 30, 2014. This quarter here, the second quarter 2015 was our 12th quarter in a row of consistent First Defense sales growth, that makes 18 in the last 19 quarters of sales growth of First Defense in comparison to the same quarters of the prior year. This growth has -- especially here in the first half of 2015 has created a backlog of orders. That backlog was valued at $1.45 million as of June 30, 2015. I do want to note that our production capacity increases are underway and on schedule to address this growing sales and reduce -- and ultimately eliminate this backlog. So I am pleased with the progress there on some significant investments in our facility and production equipment. Second, the addition of a bovine rotavirus disease claim to our existing claims against E. coli and coronavirus infections is a very important development in line extension objective that we’ve been working on for several years. We’ve been working on several different approaches to this rotavirus pathogen and since 2009 we’ve been working with technology -- vaccine technology out of the Baylor College of Medicine, and I believe this technology appears to have made the difference for us. We did first announce our positive study results of rotavirus study done at Cornell University during the first -- during February of 2015 but just recently we were informed by the USDA that the USDA has granted these claims for our product. This positions us to bring the first half of antibody product with these three important disease claims to market. The objectives and the work ahead of us is related to laboratory assay work and completing the manufacturing objectives. As we continue that work, we see a path to a product launch being possible in 2016. Thirdly, in my first point, I noted the importance of our sales growth. It’s very important to see that our gross margin is up at the same time. Our gross margin is up in both terms of total dollars and as a percent of total sales. So for the first six months in 2015, our gross margin was 59% of total product sales. This compares to 56% of total product sales during the six-month period ended June 30, 2014. 60% of our total product sales for the 12 months ended 6/30/15 and 51% of total product sales for the 12 month period ended 6/30/2014. Fourth, product development expenses are down as we expected. Many of you may remember this time last year we were just completing a significant investment in our small-scale Nisin plant. That project was completed. Those expenses were incurred and completed during the third quarter of 2014. Principally as a result of that, when we look at the second-quarter results, our product development expenses are down $489,000 or 64%. On a year-to-date basis, six months through June 30, ‘15 these product development expenses are down $752,000 or 56%. We have invested 12% of total product sales during the six-month period ended June 30, ‘15 in PD expenses. This compares to 37% of total product sales for the six months ended June 30, 2014. Fifth, principally as a result of the strong gross margin, as I mentioned in point three, and a reduction in product development expenses as I mentioned in point 4, we did report net income in 2015 in contrast to net losses in 2014. So for the second quarter 2015, our net profit was $94,000 or $0.03 per share which is in contrast to a net loss of $295,000 or $0.10 per share during the second quarter of 2014. Year-to-date six months June 30, 2015 our net profit was $573,000 or $0.18 per diluted share in contrast to a net loss of $308,000 or $0.10 per share in the 2014 period. So to summarize, we continue to execute on our two core components of our business strategy and we look forward to the balance of 2015 and beyond with great enthusiasm. We are pleased with the consistent sales growth of our lead product First Defense and the related product line extensions as well as the continuing progress we're making towards FDA approval of Mast Out. We aim to capitalize on the positive sales momentum of First Defense. I believe our sales growth is attributable to three principal factors. First, I always lead with the sales team. In the second half of 2014, we added two more regional sales managers bringing our team up to six in the field. They are located in the major dairy pockets throughout the US. They are doing a very effective job introducing First Defense to new customers, sharing the message of how First Defense provides immediate immunity and generate a dependable return on investment by preventing calves from getting sick with scours, we help them reach their genetic potential and we reduce the need for producers to the use antibiotic treatments. Second, we have benefited from an uninterrupted supply to the market of a competitive product, and third, strong beef market is definitely helping our sales. We see a lot more value on a bull calf on the dairy and makes it a lot easier for the producer to justify the approximately $6.50 investment in our product. At the same time along with the sales growth, work is underway to complete the two remaining technical sections required for approval of the new animal drug application for Mast Out by the US Food and Drug Administration. Completion of the human food safety technical section is currently anticipated around the middle of 2016. A first submission of the chemistry, manufacturing and controls technical section to the FDA is expected during the first half of 2016. Mast Out is our novel treatment for sub-clinical mastitis in lactating dairy cows. Our groundbreaking product innovation is unlike all other mastitis treatments on the market today. They are all sold subject to a milk discard period. Our goal is to revolutionize the way Mast Out – the way mastitis is treated by making earlier treatment of subclinical infections economically feasible by not requiring a milk discard or meat with-hold during or for a period of time after treatment, no other product presently on the market can offer this value proposition. Again, we’ve provided extensive additional details in our press release and in our Form 10-Q. I encourage interested investors to review these filings. With that, I’d like to move on to the Q&A. Let’s open up the call for your questions. Operator, could you help us with that?

[Operator Instructions] And our first question comes from Sam Rebotsky from SER Asset Management.

Good afternoon, Michael. This is a wonderful quarter, you and the team have done a wonderful job. Now as far as the sales going forward, I guess, the third quarter we had -- last year we had $1,770,000. We have a smaller amount of inventory. Do you think we will be able to get more colostrum to sort of be able to beat the sales from the third quarter of last year?

Honestly, I haven't looked in detail of that particular analysis. I am not really comfortable getting into that kind of projections because we did not include that in our report. But let me say this. When I say the investments are underway and they are on schedule that starts at the cow. So I am very pleased with where we stand as far as bringing on more cows, to supply more raw material, that’s being brought into the facility, fed into bigger liquid processing tanks and then ultimately into more freeze-drying capacity. So it’s not all at the end, we see these incremental advances in the capacity as we go throughout the next four and five months. And so we’re benefiting as we go and I think you saw some of that in the second quarter, because it was better than we would have thought six months ago, five months ago.

That’s wonderful. Now the rotavirus claim, you expect to be able to ship the product by the end of or during 2016. I assume is that by the end of 2016, do we have an idea of what size the market might be create for this rotavirus claim that we make and would that be shipped overseas or would that be domestically or…?

I think there's a great opportunity internationally for our First Defense product line but this application, this first license is the USDA for US sales. So we were able to get First Defense up into Canada pretty quickly after US launch. We will try the same there but those foreign regulatory efforts are different. So for our -- near-term future it's US and ultimately North America. It’s a good question, Sam, of course we don't know the answer but I can tell you it’s the third most important pathogen. You got to have E. coli, Corona is a very good add for us and adding rotavirus is rounding out the package to – like I said in the prepared remarks, the first passive antibody-product on market with these three disease claims. So we’re trying to pump the sales growth from all directions, from growing production to new sales effort with a bigger team and then now a new claim and a new format for them to talk about.

All right, great. Look, I am going to jump out of the queue and jump back in and let somebody else have some question. You are doing a wonderful job Michael.

[Operator Instructions] And we do have a follow-up from Sam.

Sure. You made a deposit on land in the first quarter. So I presume I guess – or you’re not ready to talk about the cost of the total land, and this is in Portland, or when will know relative to -- will go forward with this?

Well, actually Sam, we can’t talk about that. That’s a 10% deposit. So you can see exactly what the cost of that land would be if we were to exercise it, the option goes through December. You’ve been following our story long enough to know that we’ve been pretty creative on this Mast Out development plan trying to find the right way to take the next and final step which is commercial manufacture. And so we’ve opened up this option, because the land is geographically very preferable, i.e., nearby to our facility here. I think it’s the right price and we’re going over the next five months to explore options to get that commercial production plan in place but we didn't want to be waiting around and lose such a geographically preferable site. So we locked that up to give us an option and keeping working on all the plans to make that happen.

I don't know if you’re able to disclose this. But it's now August 13. Have we been - the period – a new period from July to now, have we been increasing our sales relative to prior period at the same time or do you need more time to disclose that?

I think I need to keep that on a quarterly basis, I mean month-to-month or week to week sales are really – we track them internally but I don't think that's a good place to get -- with the investment community, there is too much variability. We're just -- we're pumping, producing and releasing, and shipping product as soon as possible but let me accumulate three months worth of sales and get you that next update.

Okay. Well, look, Michael, I am very pleased with the way what you are accomplishing, you are showing profits, you have these major products, the Mast Out which nobody seems to have, everybody has to discard the milk. There is a one question which I have asked regularly. I'm hoping at some point you’re going to be able to sell the Mast Out prophylactically and that would sort of really increase the size of the market when you finally get there. So look, Michael, good luck.

And great. Appreciate your taking your time here. End of Q&A

Ladies and gentlemen, at this time in showing no additional questions, I’d like to turn the conference call back over to Mr. Diaz for any closing remarks.

Jamie, thanks and Michael and I would like to thank all of you for participating on today's call. We appreciate your time and attention to the company and we look forward to talking with you again at the conclusion of the current quarter. Thank you again. Have a great day.

Ladies and gentlemen that does conclude today's conference call. We do thank you for attending. You may now disconnect your telephone lines.