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Dyadic International, Inc. (DYAI)

Q3 2016 Earnings Call· Fri, Nov 11, 2016

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Transcript

Operator

Operator

Good afternoon, ladies and gentlemen. Thank you for holding. Welcome to Dyadic International Third Quarter 2016 Financial Results Conference Call. At this time, all participants are in a listen-only mode. My name is Tracey and I will be your conference coordinator today. As a reminder, please note that this call is being recorded. At this time I would like to introduce your host for today's call, Tom Dubinski, Dyadic's Vice President and Chief Financial Officer.

Thomas Dubinski

Management

Thank you, Tracey. Good afternoon and thank you for joining today's conference call to discuss Dyadic's financial and operating results for the third quarter ending June 30, 2016, which were reported in the press release issued earlier today. The press release and Dyadic's quarterly report had been posted to both the Dyadic and the OTC Markets websites. I'm joined today by Dyadic's President and Chief Executive, Mark Emalfarb, and Dr. Ronen Tchelet, VP of Research & Business Development. On today's call Mark will cover operating highlights, further details on our corporate strategy, provide an update on our professional liability lawsuit against our former professional service providers, and our special shareholder meeting to be held in December of 2016. Dr. Tchelet will highlight some of our research and scientific goals and objectives and progress to date with some of these programs, and I will close with the review of our financial results in more detail. We will then give you an opportunity to ask questions. Each caller will be allowed one question and one follow-up question in order to provide all callers an opportunity to participate. If time permits, the operator will allow additional questions from those who have already spoken. Before we begin, we would like to remind you that certain commentary made in this conference call may be forward-looking statements, which involve risks and uncertainties that could cause Dyadic's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Dyadic expressly disclaims any intent or obligation to update any forward-looking statements except as required by law. I will now turn the call over to our President and CEO, Mark Emalfarb.

Mark Emalfarb

Management

Thank you, Tom. Good evening, everyone. I am pleased to report that we are continuing to make positive progress, shifting our efforts in focus as we transition our business in research and development program from our historical industrial biotech markets to the biopharmaceutical sectors. We do so by further developing and optimizing the C1 technology to become a safe and efficient expression system that has the potential to help speed up the development, production and performance of biologic vaccines and drugs in flexible commercial scale. In August 2016, we elected an additional board member, Dr. Arin Bose. With an extensive scientific background, as well as more than two decades of biopharmaceutical experience while working at Pfizer in the development and commercialization of biologic products. We are very excited about Dr. Bose joining Dyadic's team and are already benefiting from his strong scientific background and biopharmaceutical industry experience and knowledge. Dr. Bose is excited to join the Dyadic board because he views the C1 technology platform as a leap in technology that has the potential to change the way in which both animal health, and human biotech and pharmaceutical companies bring the biologic vaccines and drug to market. We are continuing to pursue research and development collaborations, licensing arrangements and other commercial opportunities in which will leverage the C1 technology. Over the last two months, Matthew Jones, a consultant and serving as a managing director of business development and licensing, Dr. Tchelet and I combined, attended four biopharmaceutical industry conferences that would fall over 100 attendees and made three presentations on the potential benefits of using the C1 technology to develop and product biologic vaccines and drugs over the past two months. Our efforts are creating a greater awareness of Dyadic and the potential applications of the C1 technology to developing…

Ronen Tchelet

Management

Thank you, Mark. During the many years of developing the C1 technology, Dyadic scientists achieved two main breakthroughs. The first, developing a high-yield low viscosity production capabilities with C1 strains and the second, developing what we call the C1 white strain that can express and produce high levels of proteins from genes derived from different organisms with high purity. We believe that by continuing our ongoing research efforts, we may achieve additional scientific and commercially relevant breakthroughs. With C1, which we anticipate will be a lift forward in gene expression technology, prepares the potential to change the way in which both animal health and human biotech and pharmaceutical companies bring their biologic vaccines and drugs to markets faster, in greater volumes, at lower cost and it's with newer beneficial properties. This quarter, we started to bear the fruits of our R&D activities to reach these goals and to create a cost-effective platform for developing and manufacturing biologic vaccines and therapeutic proteins using the C1 technology. As we announced on September 7 and as Mark discussed earlier, we have entered a new research and development agreement with one of the most skilled filamentous fungal research institute to further engineer our proprietary C1 fungus strain for use in helping in the development and production of biopharmaceutical products. The goal of the collaboration is to develop a highly productive C1 strain and fermentation processes, accompanying associated molecular tools to produce a number of targeted therapeutic proteins for Dyadic as well as those specified by third party biotech and pharmaceutical companies that are in close reconciliation stage with us. In addition, we are founding the glyco engineering of C1 strain using advanced molecular tools that will allow for the production of proteins that will resemble the human glyco structure. This approach is a need…

Thomas Dubinski

Management

Thank you, Ronen. At September 30, 2016, cash and cash equivalents in investment grade securities totaled approximately, $55.9 million compared to $68.6 million at December 31, 2015. Cash and cash equivalents do not include the $7.4 million of cash held in escrow in connection with the DuPont transaction which we anticipate will be released on July 1, 2017. Cash and cash equivalents in investment grade securities used in the third quarter of approximately $6.9 million primarily reflex stock repurchases a $3.7 million. Repayment of cash collected on DuPont's behalf during the transition service agreement period of $1.7 million. And cash used in operations of $1.5 million. Cash, cash equivalents in investment grade securities used in the nine-month period ended September 30, 2016 were approximately $12.7 million primarily reflect stock repurchases net of stock issuances, of $9.5 million. Payment of DuPont transaction related liabilities of $2 million. Cash used in operations of $3.5 million offset by cash received from a litigation settlement of $2.1 million and other items of $200,000. Our expected operating cash burn in the fourth quarter of 2016 was approximately $1.3 million to $1.5 million. If we happen to identify additional opportunities, which we wish to pursue this could possibly change, and if so, we walked a you accordingly on our future conference call. For the full year we expect to use approximately $60 million of cash, cash equivalents in investment grade securities for the year which includes stock repurchases net of stock issuance of $11.3 million to $11.7 million, operating activities $4.6 million to $5 million. And payment of DuPont [ph] transaction liabilities $2 million offset by the litigation settlement up $2.1 million. The company repurchased approximately $2.5 million shares of common stock at the average price of $1.50 per share during the third quarter, an aggregate…

Operator

Operator

[Operator Instructions] We'll go first with Walter Schenker with MAZ Partners.

Walter Schenker

Analyst

Thank you. I noticed that the fourth quarter expenses were up slightly from the third quarter slowly by decline of a 100,000. The question therefore is as we go into the litigation the first week in January assuming that is the trial date. Can you give us some sense of how much of those expenses are going to be borne by the company. And how much of it's being born as part of the contingency with the lawyers.

Thomas Dubinski

Management

Well I also feel that question, we get our primary attorneys are on contingency so we will not incur any costs associated with the trial in that connection, we will call incur costs for expert witnesses of preparation and participation in this trial and we will also -- we've engaged jury consultants that we will be utilizing for other service providers for the litigation.

Walter Schenker

Analyst

Therefore, the expenses relating to that will largely occur in the first quarter with very little in the fourth quarter. Assuming the trial takes place starting in January.

Thomas Dubinski

Management

No most of the preparation leading up to the trial will occur in December. Because the trial begins January 6. So I believe their balance, they will be balanced between December and January, February.

Walter Schenker

Analyst

Okay. So what I'm going to keep pushing on a string therefore, all other things being equal you would not expect the first quarter of next year and you don't know this yet, now when trials come last etcetera, to -- I'm picking a number out of my head, to be in balance more in January, February and December.

Mark Emalfarb

Management

Walter. I'm not quite sure of what you are asking. As we mentioned in the past in the last conference call. That we're going to leave subject to obviously we see other opportunities. You know we don't know what the litigation well and won't bring obviously we have expected it to come very positive but we are going to aggressively pursue that as we have for the last eight years. Glad that it's coming to an end one way or the other, so we really can't give you a projection, going forward at the moment because we really don't know all facts the details of the litigation but other than the litigation, we don't expect other than potential opportunity which we are evaluating, to spend more than $5 to $6 million and then they researching and development overhead. But potentially we're looking at other opportunities to put that cash to work and to bring up higher and greater return to our shareholders and whether we will or won’t do some of those things. The board is evaluating on an ongoing basis.

Walter Schenker

Analyst

Okay. And then just one more question, you have indicated today and announced a new research collaboration with a large Pharmaceutical company. The research is being funded by them, you or in partnership that under that announcement you made today.

Mark Emalfarb

Management

By the way you're entitled to one question and you give me 16 but I'm going to answer it anyway. But anyways the but the bottom line is what we said is that we have a definitive agreement, that we've all agreed to in fact we've actually signed it waiting for them to bring and sign it back to us. So we expect that the next few weeks to have that. Partially funded by both parties, but they're contributing to that. I'm now contributing the partial times but they're also going to be contributing to the analysis of a successful in a protein that we deliver to them. And the goal here really is and it is one of the global largest pharmaceutical companies, and so if we educate some is that the power and potential of what we're dealing with here, because if we can achieve the goals and objectives we set out, this is a game changer the pharmaceutical industry in the long term.

Walter Schenker

Analyst

Okay, thank you Mark.

Operator

Operator

My next question comes from Skitz [ph], a private investor.

Unidentified Analyst

Analyst

Hey, guys how are you doing. I have one question I want to follow up with you and but there's a couple things I didn't understand so. I see you brought back about $1 million shares the first 10 days of November and about 2.5 million shares in the third quarter.

Mark Emalfarb

Management

Can I comment with you -- we bought 1 million shares in October in the first 10 days of November.

Unidentified Analyst

Analyst

So 4.5 million shares in the third in the third quarter and the first six weeks.

Mark Emalfarb

Management

No, what we said is in the third quarter we brought back 2.5 million shares. And then subsequent to the first third quarter in the month of October in the first 10 days of November we bought an additional 1 million shares. That's 3.5 million between June 30, July 1, and November 10.

Unidentified Analyst

Analyst

Okay. And so how many shares are out there and you said 3.45 and then you said 3.35 I don't which one is.

Mark Emalfarb

Management

Correct, so it's 3.45 on June 30 -- I mean September 30.

Unidentified Analyst

Analyst

And I got you, okay. So right now it's 3.35 as of [indiscernible].

Mark Emalfarb

Management

Yes sir.

Unidentified Analyst

Analyst

Okay, that answers the question. How much money do you have left over to buy shares on the buyback program?

Thomas Dubinski

Management

$6.5 million.

Unidentified Analyst

Analyst

$6.5 million.

Thomas Dubinski

Management

As of November 10, $6.5 million available.

Unidentified Analyst

Analyst

Okay that's clarified that.

Mark Emalfarb

Management

If you remember we mentioned that at least $15 million at the time we mention this. So subject to change up or down, so we're not restricted to whether we buy $6.5 million more or less but that's what we have right now based on the $15 million, over and above what we paid for [indiscernible].

Unidentified Analyst

Analyst

That that was my question. Okay, so the question that I have now that we've clarified that. Is we talk with -- you talked about an uplift in the in the fourth quarter of this year. Now I'm assuming that you going to wait after trial up list. But that's not a question, my question is and you are going to answer the question after I ask this. My question is after trial do you have all the documents prepared and ready to submit or will you have all the documents ready to prepare and submit by the end of the fourth quarter this year, and orders to up list. Is there going to be anything that's going to restraining -- that will restrain us from up listing as soon as the trial is over is my question.

Mark Emalfarb

Management

I think to better answer your question is that when we are finished with the trail and we have a clear understanding of how the outcome of the trial is; we will then me making a decision on what to do and how to move forward, in addition to it a scientist at the time and the Board is going to -- which they continuously do, evaluate what's the best direction to create value for shareholders at that point, not just related to trial but related to science, and the business and the environment and all kinds of other conditions.

Unidentified Analyst

Analyst

But that would that have to do with the uplisting. My question is, the documents I would think you hired somebody that has done this before and we've gone down this path over the last three years about uplisting and then it's always -- we don't have, we didn't get this done, we didn't get that done, we needed more money to do this; so the question is -- the simple question is, are all the documents ready to be filed if you want to uplift or is it going to be more -- a lot more time to uplift because you have to do all these things. So is it done or do you have to do a lot of things is the question.

Mark Emalfarb

Management

There are things that will have to do at that point and wait depending on what we do with the uplifting or the reverse merger how diverse -- not by reverse stock plan because you have to trade at over $2 this year for 90 days; that's number one. And if we didn't do that -- 90 trading days, sorry. So we're going to have to wait 90 trading days when we apply to NASDAQ and make sure that that stock is over $2 a share. And we hope and expect to obviously have a very positive outcome in the trial, we might not have to do the reverse stocks put to get over $2 a share.

Unidentified Analyst

Analyst

Yes, I get that. So basically what you're saying is, the trial is going to be done in February and then at that point, let's say the trial comes out -- whatever it comes out to be, then at that point you got 90 trading days -- if you've got the reverse stock split approved and you decided -- that's what you wanted to do, to get over the two; that's the hurdle to get over the two I'm assuming; maybe you want to use it, maybe you don't -- but the point is there would be 90 more trading days after the trial is over at that time. Again, my question is what all the documents by that time be none other than those two hurdles?

Mark Emalfarb

Management

Yes, the documents will be ready to be prepared and filed if the Board chooses to do that at that point.

Unidentified Analyst

Analyst

That's my question. So you could theoretically see this happening, the uplifting; so if you want to do it, no excuses by the end of the second quarter of '17?

Mark Emalfarb

Management

Yes, or at the beginning of the third quarter, sometimes depending on the 90 trading days and how long the trial goes and the jury decision, and how long that lasts in clarity but yes, somewhere in that timeframe.

Unidentified Analyst

Analyst

Okay, that's the answer that I wanted to hear. Okay, thank you.

Operator

Operator

We'll take our next question from [indiscernible].

Unidentified Analyst

Analyst

Thank you. So adding on to the question, the uplifting; is it a question of money being uplifting because if you were up listed to the NASDAQ, you would actually be providing a much more benefit for the shareholders moving forward because this opens it up to a lot more retail in a lot more firms that can actually buy into this company. So the question is, is it a money issue that you don't want to spend the money to go uplifting or is it just because in hearing your answer from the previous question -- you don't know if you're going to uplift or not because you're saying we will look at it when the court is over or on anything that the Board decides. I understand you probably try to follow before to uplift but never went through with it; and then getting your stock up to $2 with your share buyback -- should it be a difficulty, especially if the trials come up positive and the court case comes up positive, you should be able to do that expeditiously, right, after the 90 trading days?

Mark Emalfarb

Management

Yes, so to answer your question; it's not about the money because obviously we have the money. We have a very strong balance sheet and we're going to get another $7.4 million on July 1 next year from the escrow account who define transaction. It's going to be a decision at that point that the Board is going to look at science, the technology, all the things you talked about having more brokers, having analysts, all the things we've put in our proxy is the reason and some of the many benefits of potentially doing that. So the Board will look at all factors and circumstances and decide what's in the best interest of all shareholders at that point to create the most amount of value.

Unidentified Analyst

Analyst

So you can in a sense stay and still remain on the policy board if that's what the Board decides to. Okay, thank you very much and I wish you all the best in success and we look forward to getting up listed to add more shareholder value.

Mark Emalfarb

Management

Thank you.

Operator

Operator

Okay, next question from George [ph], a private investor.

Unidentified Analyst

Analyst

Good afternoon, gentlemen. There are a couple quick questions. The R&D arrangement that you they got going now is that also overseas. Or is that the domestic company.

Mark Emalfarb

Management

It in overseeing research institute.

Unidentified Analyst

Analyst

This is also in in the Netherlands.

Mark Emalfarb

Management

I'm not free to mention that but it's in Europe, in Western Europe.

Unidentified Analyst

Analyst

Okay. Is there anything in our in this arrangement where they're being compensated, late around perhaps a successful development in this. Are there any two parts to it I guess or -- are there any -- should I say -- announcement -- Because of their DuPont arrangement do you have to split any of this requests later to them associated with this.

Mark Emalfarb

Management

Yes, the first of all there are milestones if they succeed in hitting certain targets which happened goals and objectives, so we'll be very happy to write those checks. Because obviously that will demonstrate and given the data to hopefully accelerate the spread and adoption of this. And also there are certain things in right of DuPont Might have. If in fact we create things but if they do they'll have to pay additional royalties to have access to that.

Unidentified Analyst

Analyst

Okay. Thank you, Mark.

Operator

Operator

Our next question from Richard [ph] with National Securities.

Unidentified Analyst

Analyst

Mark, this one is for you, just following up on Walter's question, a little bit on -- on this research project that you have already signed and we are talking about here, could you just tell us what the goal is because it is somewhat fuzzy, just tell us what is its vision in terms of what you are trying to achieve.

Mark Emalfarb

Management

Okay. So what we're trying to achieve is taking industrial proven Piper productive cell line C1. And modify technologies so that it can be applied for both, vaccines and biologic drugs like antibiotics, in order to do that there are some scientific challenges that we believe through literature and other people demonstrating its possibility, that we can modify the genetic structure of the C1 fungus. So it can produce high level of proteins in any bodies that can completely replace at some point in the future. The way drug developed and produced verses the existing technology, that's been years today because we think we can do it quicker. And much higher yield a much lower cost that much lower CapEx. The big challenge is going to be once we can accomplish. And if we can modify and see when they do that is changing a very conservative pharmaceutical industry over to a new platform, that is different than some in news for the last several decades if not comparable with and safe. But we believe that once one or more of them do that, it opened up the floodgates because the rest of them to compete on price.

Unidentified Analyst

Analyst

Okay. So you're not trying to express some genes that they want you to express, you're actually trying to further genetically modified C1. So it becomes more productive than it has been up until now, is that a fair characterization?

Mark Emalfarb

Management

That a partial characterization, what we're actually doing are several things; number one, we are taking when we send [indiscernible] on our own, and trying to demonstrate that we can produce both of those proteins at high yields at low cost. And if we can do that that data we expect will help us in price, more people became more interest in what we're doing in C1. But both of those Proteins are not like isolated proteins. That's something C1 can do today potentially, allow genetically changing its structure. In terms of glycol engineering which is the next part we are doing. Things like [indiscernible] and etcetera there's a variety of antibodies has grown and pointed out that part of function is associated with glycosylation coating of the ways those proteins are produced. And they're currently produced using Chinese hamster ovary or CHO cells typically. And CHO cell put on a different glycol patterns and fungus, two genetic engineering synthetic biology no the advances in genomics. We believe there's scientific evidence pointing to this. So you can modify C1 genetically to mimic very similarly the glycol-engineering pattern of that CHO cell pattern. If we can do that, we believe that the game changing potential was there to apply the technology, to the development and production of antibodies, and the pharmaceutical space. And so we're pursuing our own molecules for data. And if it's a potential partnering and we sent as potentially some others. We're working with pharmaceutical and biotech companies on genes they have if they want to explore potential and the benefit of C1 for those genes coming those proteins whether a glycoprotein or not. And then we’re also as you pointed out, improving C1 making it more robust and versatile even more powerful. And easier to genetically modified to go faster and potentially even higher yields, with even greater variance. We're doing all that in those research programs.

Unidentified Analyst

Analyst

Okay thanks, Mark. Finally just a quickie. ZAPI has certain of funding that runs out in certain milestones that they need to achieve, and certain reports that they release. I was thinking that maybe by the end of this year, we would hit one of those disclosure points which could be a go or no go relating to what your participation. Is there a date that you can tell us that we can expect to hear an outcome from the ZAPI project.

Mark Emalfarb

Management

Well I think Ronen, is better equipped to probably answer that but in the end Ronen, mentioned today, that we've started to deliver antigens to those partners so, we actually been able to produce antigens or at least a couple of the antigens. And quantities that they can do what they need to do right now with them. And where working on improving yields of those antigens and others. So. I don't believe that we're going to get a go no go decision is 2017 because we already delivered protein and is taking longer than between now and the end of the year. The biological activity in the immunogenicity of those. But sometime in 2017 which you get a much better picture and sometime by the end of 2017 I believe funding for that and our part in that is going to be reduced and then those proteins will be carried on -- septa two to use those which we hope and anticipate that they will, through regulatory and through other tests and evaluations to move those forward. And we'll be off and on to other projects hopefully that point but funding from a variety of other people including potentially our own.

Operator

Operator

Then we'll go next to Paul [ph], a private investor.

Unidentified Analyst

Analyst

My question have been answered, thank Mark.

Mark Emalfarb

Management

Thanks, Paul nice to hear from you.

Operator

Operator

And we'll go next to [indiscernible] with South Well.

Unidentified Analyst

Analyst

Yes, Mark my question is do it cash burn, it looks like you basically announced two things in this conference call, one is you're new partnership with Pharma in which you're going to spend money on R&D, and secondly you hired a CRO. So going forward X. legal expenses, what kind of cash burn can we look forward to on a quarterly basis?

Mark Emalfarb

Management

I don't think we want to give quarterly basis. Quarterly bases fluctuate but I think what we mentioned is somewhere between $5 million to $6 million, that we expect to spend in 2017. However, that's subject to change up or down, depending on certain things that go on, of course. We might get some funding from third party, whether is a big pharma, small pharma, of biotech etcetera like the one that we think will have signed up in the next few weeks. We've got a variety of discussions going on with big and small pharma biotech company. So we were trying to get funding from them to carry on research and development which by the way well hopefully switch to something they want to make verses the one we might be working with. So we can actually maybe reduce some of our costs and expenses. But then there's other opportunities that present themselves for evaluating that could increase that burn.

Unidentified Analyst

Analyst

I understand that there's you can't predict that before you stand right now with your CRO arrangement; and your potential arrangement here with this large pharma; you're saying those two cost incurred in here with equate to $5 million to $6 million cash burn in calendar 2017. Is that right.

Mark Emalfarb

Management

Yes.

Unidentified Analyst

Analyst

That's what I want to know, thank you Mike.

Operator

Operator

I am showing no further questions at this time, and will now turn the call back to Mr. Emalfarb for closing comments. ark Emalfarb: Some of you have expressed some concerns over our planned R&D spend over the next several years, just like Wilson just expressed. And I like to speak to you as significant shareholder of Dyadic and that is Dyadic CEO. As many as you know, Francisco Trust and [indiscernible] Trust currently own a combined interest in Dyadic common stock in excess of 20%. I fully support the current business in research plans of the company, which have the potential to create additional value for all shareholders. I view the company's continued investment and further developing its C1 platform is a safe and efficient expression system for use in the development and manufacturing biologic vaccines and drugs. It's a potentially significant return on our investment. Speaking again as Dyadic CEO the board of management are acutely aware of our responsibility to maximize shareholder value, while evaluating the risk and proposition relating to every decision we make. Both management and the board are perfectly aligned our belief that our current business plans to monetize our C1 technology, not only prudent put compelling. I want to take this opportunity to thank our very hard working employees, consultants, a dedicated Board of Directors our research partners and our shareholders for their support. Thank you all who taking place on today's conference call.

Operator

Operator

This concludes our program for today. You may all disconnect.