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Healthcare - Biotechnology - NASDAQ - US
$ 3.61
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$ 28.3 M
Market Cap
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P/E
EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2016 - Q4
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Executives

Joe Diaz - Lytham Partners Michael Brigham - CEO.

Analysts

Sam Rebotsky - SER Asset Management.

Operator

Good day. And welcome the ImmuCell Corporation Fourth Quarter and Fiscal Year 2016 Financial Results Conference Call. All participants will be in listen-only-mode. [Operator Instructions]. After today's presentation there will be an opportunity to ask questions. [Operator Instructions]. Please note this is being recorded.

I would now like to turn the conference over to Joe Diaz with Lytham Partners. Please go ahead. .

Joe Diaz

Thank you, Andrew, and thank all of you for joining us today to review the unaudited financial results of ImmuCell Corporation for the fourth quarter and full year of 2016 which ended on December 31, 2016.

My name is Joe Diaz, as the conference call operator indicated 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 Question-and-Answer Session. Statements made by the management of ImmuCell during the course of this conference call that 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 belief, 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 and filings the company submits to the securities and exchange commission.

Investors are caution that forward-looking statements made during the course of this conference call are based on management's current expectations, and actual results could differ materially from the statements made. The company disclaims any obligations to update forward-looking statements.

A more complete safe harbor statement was included in today's press release filed by the company. With that let me turn the call over to Michael Brigham, President and CEO of ImmuCell Corporation.

Michael?.

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

Thanks Joe and thank all of you for taking the time to participate on today's call. The results discussed in this call and in today's press release are preliminary and unaudited. We do expect to our audit, annual audit work will be completed by the end of March and we will file complete audited annual report on Form 10-K at that time.

The results for the fourth quarter and for the full year 2016 came as anticipated and as we projected during the announcement of our third quarter financial results.

No real surprises, sales for the fiscal year 2015 in the prior year for comparison purposes did benefit from the temporary absence of a competitive product from the market which allowed us to gain additional markets rolling our first -- product line, had better market dynamics in terms of -- prices, and the backlog of orders that needed to be filled.

Despite those challenges we are -- for the 2016 fiscal declined modestly by 7%. And we are encouraged by a strong start in the fiscal year. As noted in today's earnings release since 2012 we have four year compound annual revenue growth rate of 15.4%. The strong work by our large sales team nearly doubled our sale since 2012.

I would like to give the emphasis of the call was we really see if it is growing in a relatively near future and slightly more distant future and about 2018, the -- is a bottom line and the pipeline deal for the fourth quarter and full year 2016.

We recorded a 10th consecutive quarter of positive net operating income and reported net income of -- per diluted share for the fourth quarter and $508,000 or $0.12 per diluted for the year ended December 31, 2016.

Total sales around the fourth quarter were down 18% in comparison to the fourth quarter of 2015 as I said earlier fiscal 2016 revenue decline of 7%. Despite these declines sales at first -- increased during 21 of the past 25 quarters in compression to the respective periods prior year.

Let me provide a color at some of the circumstances that affected the 2016 results. For a long period of order backlog, which began early 2015 and in the middle of 2016 disrupted normal shipping pattern. We over flowed our distribution chain with product as we filled nearly all outstanding orders by the end of the second quarter.

we completely eliminated the backlog of orders during the third quarter of 2016. Given the second half of '16 distributor inventory levels reset after this long period of order backlog which was made possible by the investments we made to increase our liquid processing capacity by 50% and to double our -- driving capacity.

Compared with product that experienced interrupted supply in the market during late 2014 through the first half of 2015 has returned to market from customers to have the ability to back using these products.

We have loyal customers that we lost when we could not -- our product and customers who were unable to -- supply, some moved to other products and with or without disease claims and some opted to use no -- preventive at all. Our sales team could not focus aggressively on acquiring new customers during the period of scares product supply.

The value of the -- which was dropped from approximately $450 during the 2016 to very little today The average -- milk price has declined from $15.80 per 100 pounds during 2015 which compares to $22.34 for 2014 to $14.87 for 92 pounds in 2016.

We operate in a cyclical business where we're seeing signs of these market dynamic -- back on a more favorable directions. For example, the low price has risen approximately $16 to $17 -- during the past 3 months.

We are actively looking prospect for our business going forward and support the quote that Bobbi Jo Brockmann our VP of Sales and Marketing offered in her press release, off to a strong start for the new year.

Given our recent investment sales personnel and marketing programs we are well prepared to reengage customer's loss during the period to eliminate product supply and acquire more new customers given our recently increased production capacity and available inventory. This makes us optimistic about the long-term health of our business.

Our objective is to bring the most effective technology to market. Our competitors company like -- and Merck maybe bigger than we are, but they do not offer the kind of product we do. Gaining market share from these existing competitive products provides a great growth opportunity for us.

Now that our sales team is back to establishing new customers, it's important to understand how well our message resonates with the end user. Capital -- is a market share leader. This product -- through vaccination stress and can be inactivated by colostrums. Which is why we will recommend to withhold colostrums when administering --.

We provide care immediately mandate which can administer on -- as soon after birth is possible.

We putting our -- product from Elanco is indeed back in the market, their volume is relatively small compared to ours and -- but it's it too aggressively displacing by reminding customers about the importance our -- virus claim that -- product does not have and by discussing new data from our lab that shows that -- contains about 28 times more E.coli antibody which would provide cows more protection.

So looking ahead we completed the next significant progress towards our product development objective, providing a -- virus claim to a product line later this year. Which will give the first cap level product to offer this breath of claims. We also anticipate establishing USDA claims for our -- coronation of the First Defense Technology.

With this increased production capacity in place we have begun to engage additional distribution partnerships to grow -- in the national territories. We see that the total market is growing our message is very conducive to gaining market share from these competitors while also continuing to grow the pie by establishing new users -- per venture.

So we like the cap -- market. We believe that the disease cause -- these industries about $740 million per year, that’s a good sized market.

And I bet this market is even bigger, with last out we will enter the -- service market in addition to our existing -- business, --- cost to billing industry about $2 billion per year, clearly the single largest cause the economic harm to the industry.

Certainly, our -- treated with traditional antibiotic products and treated generally for clinical infection. That's when the cow produces non-scalable milk. Our groundbreaking product innovation is unlike all other antibiotic treatments on the market today.

Our goal is to revolutionize the way -- is treated by making a treatment at subclinical infection economically feasible by not requiring to -- during the period of time after treatment. No other product other market can offer this value proposition.

-- the active ingredient in -- is a bacteria that is not used in human medicines and would not contribute to the growing concern that widespread use of antibiotics encourages use the growth of antibiotic resistant bacteria or super bug. Hopefully that gives you all a general insight into our sales and marketing investment and our vision.

Over the past years we've explored several alternatives strategies to access commercial scale production of Mast Out. First, we engage the contract manufacturing that become a cost of production and the required minimum volumes would be too high under contract.

Then we explored corporate partnerships that would have lost a significant portion of the gross margin to the --. During 2016 we issued the -- of almost 1.8 million shares raising net equity of nearly $8.5 million in two separate financing transaction.

We did not take the dilution created by the issuing shares lightly, but this strategy had allowed us to move forward towards commercializing Mast Out on our own, while controlling the costs of production and not sharing sales or gross margin with a partner. After these two equity financings, we still have less than 5 million shares outstanding.

We feel this as a prudent price to pay to give us the opportunity to enter this huge market. To update on that project, we initiated construction of our $20 million pharmaceutical facility to -- again the active ingredient is Mast Out.

During the third quarter of 2016 approximately 3.3 million was invested in this project, by December 31, 2016 about $1.2 million of that amount recorded in accounts payable at yearend. The spending on this project is heavily weighted through the September 30, 2017 comprised of the bulk of the construction activity and equipment purchases.

And thirdly, if you look at what's new page on our Web site at www.immucell.com the new progress -- construction, they are containing to provide periodic updated there. The tangibles and visual able progress is very exciting to us.

The objective is to complete the construction and then -- installation and qualification in 2017, followed by process validation in 2018 with subsequent regulatory filings thereby maintain the timeline for our anticipated FDA approval from 2019.

During 2017 we expected to devote go more time to go in relationships with the -- investors one on one meeting, like the con conference participations and other opportunities that will broaden our awareness with the national investments community.

I believe this will support our existing long terms investors and we contribute to the liquidity of our entire shareholder base. We look forward to great a year. With that I'll turn to the operator to open up the line for your questions..

Operator

[Operator Instructions] The first question comes from Robert Manning, private investor. Please go ahead..

Unidentified Analyst

Could you help us sort out a little bit all the noise going on here recently, Elanco being in and out in the backlog and then drop in bull calf prices. From the underlying trends you've had a gain in market share quite consistently over the last few years.

Is there any way to get it whether that gain in market share is continuing if we ex-out the noise or do we just kind of have to wait and see for a while?.

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

You are right that's a good description about noise. There is the lot of noise, the Elanco absence we believe was related -- to going back to their acquisition of this product, when they acquired Novartis Animal Health, they had some production problem, they were out, almost largely out from late '14 to the '15.

So that was also quite a spike to us, but they are back and we see them head to head on the farm every day. So they have no intention to dropping their product, we know they're back and we believe they're back to stay. The backlog resulted from several things, I think that was a big piece of it.

But once we hit that backlog, the noise created by that, it makes some comparative periods very difficult, it really affected the second half of ’16. I’m not try to dodge your question at all, Bob, but I think the best answer really will be in front of us within the first quarter of ’17 and we're really not in the business of making projection.

But we are -- we do like the starts of the year and we're one-third through the first quarter, so there is a long way to go. And I don’t have a better answer definitively to your question until we get those first quarter numbers together and start moving ahead without backlog and with level of competition in the field. .

Unidentified Participant

You can’t answer a question if there isn’t any answer yet, so I don’t blame you for that. Now why is the Elanco issue relevant comparing Q4 of ’16 to Q4 of ’15. Elanco was back in the market last year, so that shouldn’t be -- well that’s the factor in the year-over-year comparison.

I don’t see why that would be a factor in the Q4 versus Q4 comparison?.

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

No. I refer to year-over-year, you're exactly right. I think the two-fourth quarters and really the mostly the two-third quarters they're back.

So you’ve got the first half of the year definitely influence by the absence of the competitive product and the second half of the year heavily confused with that noise so to speak related to filling that backlog and distribution digest and doesn’t order right back and so the level out.

I feel like we reset those levels to normal levels, we’ve regained their confidence. We virtually ship the day of order certainly within the next day and at the latest, two days later, they’re back to understanding that and not pilling up orders, not ordering, not trying to get ahead in the queue. There is no queue, place an order and we ship sift.

So I think you’re right this put in the partner. The Elanco is more first half to first half in always and the backlog is more year-to-year and especially second half to second half..

Unidentified Participant

So here is the way to look at your year-over-year numbers for the fourth quarter that looks really positive and again I don’t know how much of this is noise. But sales did drop this quarter, the last quarter 1.3 million of your sales was from backlog.

So your orders quarter-to-quarter, unless I'm missing something with my arithmetic, your orders with 1.5 million in the first quarter ’15, up 50% to 2.2 million this quarter. I’m assuming that the sales were the same as the orders, because there is no backlog.

So I mean that 50% increase in orders probably is noise as well right, I mean things maybe going up, but no reason to think that that's a secular trend.

Tell me what you can reacting to that non-sense?.

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

No, I think about that a lot, Bob. What would have really worried me after that third quarter drop, is to see a sequential drop going in the fourth quarter. I would have felt like we were slipping on a banana peel going out the year. And I was very encouraged to see that fourth quarter stand on top of the third quarter.

Normally, we'd compare year-to-year, quarter-to-quarter rather than sequential quarters, but in this period of all those noise, I’m looking for something that make sense of and I really was encouraged by the fact that, as we said in the press release on a sequential basis sales in fourth quarter ’16 grew 12% compared to the third quarter and in September 30, 2016..

Unidentified Participant

Is there normally a seasonally strength in fourth quarter versus third?.

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

There is some of that there, I just -- first quarter is always are best, the other three quarters are generally similar. But there is a second trend behind first quarter's best and the fourth quarter is second best. So some of that can be attributed to seasonality. So I want to be careful not overstate the sequential message of the fourth quarter.

But I kind take some comfort, we build some confidence out of the fact that the negative didn't happen. Despite a seasonal -- if we'd seen a decrease in the fourth quarter, I think we would have a real cause of concern.

So that to me is sort of the leveling off, whether it's seasonal or clearing the noise and again I point to the first quarter as the first time we consult to have possible clear vision to answer your original question. .

Unidentified Analyst

Okay, sure. Now first quarter last had huge orders. But I assume a lot of that was Elanco not being there any other stuff. There is no way we're going to have the same or maybe that's seasonally always that strong.

I mean could first quarter's orders this year match last year?.

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

No we looked at this real hard with Bobbi and we came here honestly with legal too because we're really just very hesitant to get into the projection. I don't know what's going to happen tomorrow, but we do like to start the year.

And again in my kind of analogy of the banana peel here, I think the two slips that we've avoided would have been much more of concern if I had seen the fourth quarter continue to slide.

And I'd a bit anxious if I didn't see a good strong start to the year, but I also issued some caution in that kind of projection, because I don't know what's going to happen tomorrow for the remaining almost two thirds of the quarter are still in front of us..

Unidentified Analyst

Last year's -- without getting in the future, was last year's first quarter orders was there a lot of non-recurring good stuff in that quarter?.

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

Honestly, I'm not sure what's naming good stuff, what is that?.

Unidentified Analyst

Well I mean if the orders we're so strong that quarter that it looks like an aberration or is that an indication of what it's normally like in the first quarter. I haven't been invested in you long enough to have a really good feel for the seasonality, all I see is that huge first quarter last year for orders. .

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

Yeah. First quarter definitely is always stronger, but that first quarter I think two things going on we were picking up all the Elanco business they had, they either did nothing or they came to us. I mean there is a couple of alternatives, but most of them either chose not to treat their calves or they came to us.

So that's certainly was huge in the first and second quarter. But on top of that, first quarter even with or without a competitor, in or out of the market, first quarter is always best. So that's why we generally stay out of the sequential quarter comparison and go year-to-year.

So when we stack up first quarter '17 really comparing to fourth quarter '16 would not be relevant, we got to compare to first quarter of '16. And we got to capitalize and continue the momentum that we see as good start to the year. .

Unidentified Analyst

Okay.

Now I assume that whatever we get for orders this quarter we can ship them now?.

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

Yes, it's a lot of fun Bob.

I mean, I would tell you what's not a lot of fun, having a sales team out there, begging for products, allocating product amongst distributor warehouses and the shoe has turned, it's the other way around, the manufacturing group is now where they should be and the inventory levels are ahead of sales and the sales team knows that when they get an order placed, it's going to ship within a day or two..

Unidentified Analyst

Sure yeah. I've got a couple of other things to ask, but I don't want to hog this whole thing, if there is other people in queue, I should let them go ahead. If not I'll ask you some more stuff..

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

Good nice Bob, I appreciate it. Andrew and I'll bring them right back, I don’t know what's in the queue..

Operator

[Operator Instructions] And we have Sam Rebotsky of SER Asset Management. Please go ahead..

Sam Rebotsky

It's been a tough year and I guess with the snow, I guess it was -- you had to get your numbers out..

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

But the snow, the sleep, the rain, the heat. The earnings date is the earnings date, and here we are, where we're getting pounded by some pretty heavy snow.

But, had a tough year, but in the end, big picture, I mean I don’t mean to be complaisant or anything, I don’t like a 7% drop, we're still in the $10 million revenue range and 7% is, given all our factors I tried to describe here and consistent with descriptions of past, especially third quarter.

At least we understand it and I don’t think it's disaster, but we rather be positive than negative, no doubt about it..

Sam Rebotsky

That sounds good Michael. Now let's see the inventory you state, you didn’t put the number out, what the inventory is, but you talked about the inventory being able to grow.

What would be a desirable -- with inventory back to our target level, what would our target levels be and where do we want to be with inventory?.

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

Yes, we want to be pretty much where we are. So the dollar amount I'm going to differ to the K filing, we'll wrap-up with the auditors and get the year-end balance out. But conceptually or strategically, where we want to be is, three months of sales. So we want to stay well ahead, not too far ahead, because this is a biological live product.

Tie up too much money or too much live antibodies on the shelf, but two to three months stocking of two to three months of sales, that's the arrangement. That's what our VP of Manufacturing, Elizabeth Williams is managing and achieving..

Sam Rebotsky

Okay, and now with your attempt to get distributors overseas.

Do you -- would it be more helpful to sell product once you have the rotavirus or what type of sales or what kind of, what are we looking for, when do sign some distributors up? I presume we have product to sell in Japan, which we didn’t have enough previously, but what areas do we want to sign-up and what percentage of the sales do you think we would achieve for international?.

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

It's been pretty small to date, as we considered Canada and North America, outside of North America we really don’t have a lot of sales. We're in South Korea and Japan. We are looking at some middle eastern countries where we think there is an attractive market and we think there is some productive partners to work with and we'll keep going.

I have the caution this international development is something we didn’t do, because when we had products supply, because bringing them on and then saying that I can't ship to you --. But that's turnaround, so now we're ready to bring them on.

We are active, we are engaged, but it is long lead, that’s a regulatory lead and what we're looking for is relatively small regional distributors that now had to do all the leg work and all the in countries sales and marketing. We simply cutoff that manufacturing, we ship to them they do the lag, they do the sales.

So it is a bit of the longer lead, but just building momentum and knowing that we have the product to bring on new customers whether they're in in North America or elsewhere, that's where we are now. So that’s why we moved forward with that. But to your other point on rota, it’s definitely going to help. But it’s not a requirement.

So we’re moving forward with -- international expansion, but just bringing rota on top of that to try to grow will help in all markets, and some more than others..

Joe Diaz

Okay.

I think we thought that was the second freeze-dry, a piece of equipment, we could possibly achieve 20 million of sales and with rotavirus both domestically and internationally, it presumably could increase more than, I don’t know what number, what percentage, but we should be able to increase another percentage relative to adding rotavirus?.

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

Yes. Now it’s one of the competitive disadvantages we have today, when we go up against -- very hard, they have the rota claim and that we do not today, that is true.

So we’re excited about removing that competitive disadvantage and saying get back to -- we've both got corona, with both got rota, only ImmuCell has E.coli and why would all in the -- why you vaccinated that newborn, why not deliver immediate with First Defense. It plugs the hole in our competitive story..

Sam Rebotsky

Okay. In the current -- in the February tenth issue of -- Dairy, they talk about BVD, Bovine Viral Diarrhea.

Is that the same as --?.

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

We don’t have claim there, it similar, I mean diarrhea, dehydration, any disease that affects the calf, whether it's -- we have claims for E.coli and corona, again soon we hope rota. We also know this without putting a claim behind it, a calf that is born in -- is always going to lag. So it maybe a different pathogen but it gets everybody.

If it didn’t get weekend upfront by a corona infection, by an E.coli infection, by a rota infection, it stayed strong for those first few days.

As she matures and her immune system matures and she is way better --, we know she has better chance of fighting -- fighting diseases that may not be on our labor claim, but those first few days are the critical period of life to get that calf off to a good start. And the contrary if she doesn’t get off to a good start she'll always lag.

So we'll always be behind that calf, but that didn’t scatter or didn’t suffer that huge amount of stress to survive it’s -- arrangement right through the better and stronger and earlier winning might see the better milk production and quicker maturity to milk production..

Sam Rebotsky

Michael, I'm excited to here that you expect to more one-on-one investor.

And I presume you probably will appear against more conferences telling the ImmuCell story, because with approximately book value of $4 having written-off, so much money to get to where you are with the matched out and being very conservative, I think it’s a story that has to be told on a regular basis.

Because I think when people realize that such a clean balance sheet and that you spend so much money that’s been written off, that ImmuCell would be compelling story.

So do you think you’re going to go to more conferences besides one-on-one or have that --?.

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

Yes Sam. You've been very consistent and very patience on that history, I mean you’ve being with us back prior to our initial investment and our significant IR program. Back before we started to work with Joe Diaz and his group at Lytham.

So we're more maturing that way, we used to think that -- we used to file our SEC report and largely called that the IR program. So I'm working with Joe, we're getting it scheduled together.

I think it's a little bit of both and I think Joe is a good manager for me and a good leader for me and picking the best places to be happy everywhere and we do have a business to run, but this is -- with the importance new investors, the important of the new products coming to market, this is the time to be more active on the Investor Relations side of the business..

Sam Rebotsky

Yeah that's exciting Michael. And I think you could get a greater valuation more consistently and develop a shareholder base that are willing to -- the more they understand the story the more they might be willing to invest deeper. So good luck and let's see what happens in the first quarter when you releasing. Good luck. .

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

Awesome thank you again Sam. .

Sam Rebotsky

You're welcome. .

Operator

[Operator Instructions]. And we have a follow up from Robert Manning. Please go ahead. .

Unidentified Analyst

Michael on the market share issue, it was a bad year for the industry last year we were down 7%.

Do we have any idea we might have even gained market share at that level? Do we know any of that yet or is that too early to know?.

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

For me it's little too early. I think let me point to the K and the commitments to get that market share updated in the K filing is that it's the work we haven't done yet. [Multiple Speakers].

Unidentified Analyst

And given all that's going on I think that that's maybe -- might be a continued. Now the rotavirus, first you instated with the FDA there is this thing they call a PDUFA date, when they're going to decide or probably decide. Do we have anything like that.

I don't know and are you sure, who decides that? Is that department of agriculture or the FDA?.

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

Let me make sure Bob I understand question. You mean --..

Unidentified Analyst

The rotavirus, who decided exactly?.

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

Okay, when you said FDA, I got over to --. The rotavirus is at USDA. Yeah, so we're in the final stages there and our best estimate and we're pushing to break it and open up to push it.

But we're looking at third quarter all of our efficacy has been filed and reconciled and some concurrence with the U.S., we're not going to do another animal study, the safety. That file is pretty well together and we're working down the final manufacturing objectives. And you just don't know exactly how much time the USDA will take.

We have a really -- honestly, I really believe we have a good relationship with the USDA, they're following our file very closely.

There are no surprises, they know exactly what's coming and with a reasonable turn on their final review of the final stages that's what gets us to this third quarter target of getting a license share from the USDA on rotavirus. .

Unidentified Analyst

The changes in Washington have any impact, I know a lot of agencies people are just scared they don't know what to do about stuff. You see any of that, I guess we don't have a new department of agriculture head yet, but we will pretty soon.

You've got any sense, is that a uncertainty or is that something that will just work through the bureaucracy and --..

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

Not to me. Our relation with the people that we work with now, if it is the USDA that it's really a couple of people. Now for our relationship or our application those people are the same in both administrations. I don’t see anything positive I don’t see anything negative with the change in D.C..

Unidentified Analyst

Do you get any sign that there scared by the change in -- I mean I know a lot of people working level in other departments that are just scared to do anything these days, do you get any sense of that?.

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

I don’t know, the only thing that I've seen over the years, it doesn’t change, because they're constantly underfunded and over overstressed and effects turnaround time. So we're trying to offset that with just good communications frequent phone, e-mail and in person visits just to become a priority on their very scares timing..

Unidentified Analyst

Yes, but here in contact with them enough to know that they are not particularly fear full right now, is that a fair statement?.

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

I'm not seeing that, we're not seeing that.

Now we are seeing compliance with our expectations are delivering on our timelines, in some cases we are seeing even better than expected terms on certain submissions, so it's a good open dialogue and that's what it should be, they need to maintain their independence, they need to make sure compliance, but it's a relationship and we have a good dialogue and that I do believe that helps us, I believe that if our team faces a problem, they'll be there for us hitting that third quarter project..

Unidentified Analyst

And the last thing to the extent that you can give any -- asking for I guess on rotavirus. You feel excited about this, I mean you -- bigger than a sparrow, smaller than an eagle.

I mean, I don’t have any ideas, just likely to add 2% or 25% and I know you can't say anything for certainly, but to the extent you can give me a wide envelope of speculation I'd be interested in maybe you can't do anything at all because I know you're excited..

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

Here's a couple of thoughts, because the bottom line is I don’t know, but I do know why we spent so many years, trying to develop this claim. I mean we wanted this rota claim from the very beginning, it's a very important -- pathogen. So it has been a priority through several different initiatives because we do believe in the potential.

So that's a very vague answer, but here is the more specific answer, not the dollar because I just don't know, but one on the dollars is one caution and then one competitive. The caution is, that it is going to be a premium product, we're basically doubling production cost. We're making these rota antibodies is expensive.

So it's going to be a premium product. So that is going to have some effect. -- antibody demand, we need to put it out there to the market -- product has a rota claim, it is inexpensive.

So we're going to have sell the benefits of our product and we're talking about a 250 cash product to a $6 -- First Defense cost of rota premium, so the PEDUFA has to see that benefit.

But if we can achieve our sales goals and then achieve our value, PEDUFA sees and preserves the value that we think we're delivering then we are really going up against -- because that is the one of the biggest disadvantages we have right now and then sort of get somewhere close to your dollars expectation -- is the market leader -- sells about twice the volume we do.

So they sell at about half our price, so we're similarly they're a little ahead of us on the dollar side, but that's just huge opportunity, we're not going to get it all, but because we got rotavirus, we're going to be able to compete much more effectively against the market leader again that has twice our volume and about similar dollar value of sales..

Unidentified Analyst

Do we know if they are doing anything to work on rotavirus and would we know if they were doing it?.

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

We already have it, they've always had it. Their product is coronavirus and rotavirus. Our product [Multiple Speakers]..

Unidentified Analyst

I got it. Okay. But they don’t have the E.coli..

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

They don’t have the E.coli, we both have corona and soon to be, we'll both have rota..

Unidentified Analyst

Do we know also doing anything on E.coli?.

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

I don’t know, but I really do doubt it. This is a very old product and it came to the market 1970s, it is not a priority to our -- and we don’t see them marketing it..

Unidentified Analyst

You're saying -- gets too small..

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

It’s too small, yes. I really doubt it..

Unidentified Analyst

But that’s great. I mean you probably know this, as you can't know for sure. Thanks very much for your time. Thanks very much for your time, sorry to hog so much of it, but you got such [Multiple Speakers], I’m still really low on my learning curve..

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

Well don’t downplay too much, you know you’ve got it figured out by now. I appreciate you time to taking to understand the business..

Unidentified Analyst

Well. Thank you very much. It’s a real cool for doing. .

Michael Brigham President, Chief Executive Officer, Principal Financial Officer, Treasurer, Secretary & Director

Awesome. Thanks Bob..

Unidentified Analyst

Thank you..

Operator

This concludes our question-and-answer session. I would like to turn the conference back over to Joe Diaz for any closing remarks..

Joe Diaz

I would like to thank all of you for participating on today’s call, with special thanks obviously to Michael for all of his comments and his answers to your questions. We certainly look forward to talking with you again at the conclusion of this current first quarter sometime in the middle of May or there about.

But until then, I hope you have a great day and we’ll talk you soon. Thank you..

Operator

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

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