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Dyadic International, Inc. (DYAI)

Q2 2020 Earnings Call· Sat, Aug 15, 2020

$0.82

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Transcript

Operator

Operator

Good evening, ladies and gentlemen, and thank you for holding. Welcome to the Dyadic International’s Second Quarter 2020 Financial Results Conference Call. Currently, all participants are in listen-only mode. My name is Jerry, and I will be your conference coordinator for today. As a reminder, please note that this call is being recorded. At this point, I would like to turn the call over to Ping Rawson, Dyadic’s Chief Financial Officer. Please go ahead, Ms. Rawson.

Ping Rawson

Management

Thank you, Jerry. Good evening, everyone, and welcome to our second quarter 2020 earnings call. Our press release with Dyadic International’s second quarter 2020 financial results was issued earlier today. The press release on Form 8-K and Dyadic’s Quarterly Report on Form 10-Q have been posted to the SEC and Dyadic’s website. On today’s call, our President and CEO, Mark Emalfarb, will give a review of the business and corporate accomplishments for our second quarter of 2020, including a brief summary of our research and business development efforts. I will follow with a review of our financial results in more detail. We will then provide you with an opportunity to ask questions. Matthew Jones and Ronen Tchelet will join Mark and I to answer your questions. At this time, I would like to inform you that certain commentary made in this conference call may be considered forward-looking statements, which involve risks and uncertainties, and other factors that could cause Dyadic’s actual results, performance, scientific or otherwise, or achievements to be materially different from those 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. For more information about factors that may cause actual results to be materially different from forward-looking statements, please refer to the press release we issued today as well as risks described in our Annual Report on Form 10-K for the year ended December 31, 2019, and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, particularly in the section titled Risk Factors. This information can be found in our other filings with the SEC when available. With that, I’d like to turn the call over to Mark. Mark?

Mark Emalfarb

Management

Thank you, Ping. Welcome, everyone, and thank you for joining our second quarter conference call. I hope that you and your family are safe during these difficult times. I’m pleased to report that we have made terrific progress on multiple fronts in the second quarter, further advancing and strengthening our diverse and growing portfolio of opportunities by adding new top-tier collaborations in both the animal and human health fields. We’re expanding our commercial reach in large and growing addressable markets, while continuing to report exciting and new scientific data and progress. We are involved in a number of collaborations helping combat the COVID-19 pandemic. These developments reinforce the broad application potential of our C1 technology, as well as some of its key attributes, including high productivity and low cost of goods. The continued growth of our company has added to our visibility in the investment community with our recent inclusion in the Russell 2000 and 3000 indices, providing us the opportunity to further broaden our shareholder base. Our management team remains highly energized by the significant number of opportunities available to us, supported by best-in-class scientific partners and our ongoing R&D collaborations, funded partially or fully by our partners, our objective and diverse pipeline of potentially high-return projects. In response to COVID-19, we have taken the necessary health and safety measures to protect our employees, lab teams and partners around the world who, for the most part, have been working remotely. We are fortunate that beyond those changes in the way we conduct our daily work, COVID-19 has had minimal impact on the company’s ability to continue our progress. Tonight, I would like to provide some additional color on some of our most recent business and development and scientific accomplishments and conclude with comments on the S-3 registration statement we…

Ping Rawson

Management

Thank you, Mark. Before I begin my discussion, I’d like to provide you with a few key business and financial highlights. Dyadic’s financial position remains strong with approximately $32.1 million in cash and investment-grade securities, including accrued interest with no debt. Our cash balance at quarter-end is higher than we typically report due to the low interest rates currently available for investments. Our cash burn for the quarter and six months was $1.9 million and $4 million, respectively, in line with previous quarters. I will now discuss our operating results in greater detail. We ended the quarter with cash and cash equivalents of approximately $11.8 million, compared to $4.8 million at December 31, 2019. In addition, the carrying value of short-term and long-term investment-grade securities, including accrued interest at June 30, 2020 was approximately $20.3 million, compared to $31.2 million at December 31, 2019. Turning to income statement. Research and development revenue for the quarter increased to approximately $524,000, compared to $391,000 for the quarter ended June 30, 2019. We reported an increase in the cost of research and development revenue for the second quarter of approximately $624,000, compared to $322,000 for the quarter ended June 30, 2019. The increase in revenue and cost of research and development revenue for the three months ended June 30, 2020 reflected nine ongoing research collaborations compared to four collaborations for the same period a year ago. The increase in provisions for contract losses reflected the activities of one biopharmaceutical collaboration research project. Research and development expenses for the three months ended June 30, 2020 increased to approximately $1,116,000, compared to $818,000 for the same period a year ago. The increase primarily reflected the cost of additional internal research projects. There were no research and development expenses related party for the quarter ended June…

Operator

Operator

Thank you. At this time, we’ll be conducting a question-and-answer session. [Operator Instructions] The first question is from John Vandermosten, Zacks International Research. Please go ahead, sir.

John Vandermosten

Analyst

Thank you, and good afternoon, everyone. Thanks for taking my questions. I want to get a sense of how you might structure a deal with one of your larger partners that want to take C1 to the clinic with the intention to commercialize. What might be some of the things you’d look for in something like that? There’s normally the upfront milestone and royalty type of deal. But is there any specific parameters that you’d look for to take it to that next stage?

Mark Emalfarb

Management

Well, I think, we’re open to virtually any type of parameter based on who the party is. If the party is a big pharma company versus the government of Israel or the European scientist group that is actually a program that we’re embedded with. So we would be looking for a pharmaceutical company, or HHS, BARDA funding from some other governmental agencies to help us with the funding to get into Phase I, Phase II and possibly Phase III, so upfront cash milestones and royalties from a pharma partner. And then the key here now is going to be once we get this animal data finished, the mice trial data that’s in Israel, that will be done within about a month, and then they will be going into, I believe, hamster trials. And if the results continue to look as promising as they do now and we have people that we have lined up and have discussions with on an ongoing basis, and then the same thing in the European – on the hamster trials that they’re waiting to start. So animal data is going to be very, very important. And we’re very confident that our vaccine candidates, in those particular instances, we have the most two advanced programs are performing very well based on in vitro and now in vivo data in mice. And based on what we’ve seen and read from other people on a similar approach, that approach we’ve taken that was originally developed by the European scientists and institutes that we were involved with ZAPI seemed to be as good or better approach at delivering an efficient and effective vaccine. But what we can do apart from anyone else that we’re aware of is make billions of doses very affordably all over the planet. So hopefully, that will help out there. So that’s – those things are in motion and we have a lot of conversations going with a lot of parties, including some of the big names that you might be aware of.

John Vandermosten

Analyst

Okay. Thanks for that, Mark. And animal health, that’s been a big deal for Dyadic. And the great thing about that is it’s just got a faster pathway to market on the regulatory side. How – who is closest there to kind of get into a point where they would make a decision to go ahead with the commercial-type approach? Or what category are they in – or whatever information you can give me, I’m interested to see who is the leader right now?

Mark Emalfarb

Management

Well, I mean, we’re dealing with all four of the top global health companies in the planet, right, and then another fifth had just started. So two of them just got going. The other three – one of them, obviously, we’ve been doing for a long, long time and that company is certainly ahead in terms of data. And they’ve got multiple animal health products that they’re having us express. So we hope that sometime late this year, early next year that one or more of those products will move into the animal studies towards commercialization. So that’s when we would expect that one or more of those companies to move forward towards commercialization late this year or early Q1.

John Vandermosten

Analyst

Okay. Great, great. And the ATM, that’s a great way to pick up cash over time. Have capital needs changed? Or what’s behind that? And how do you envision using that to fund?

Mark Emalfarb

Management

Yes. So I’m glad you asked that question, because as the largest shareholder, I’m very mindful of any ownership dilution for all of us. And we continue to have a strong balance sheet and we’ve demonstrated that we are disciplined allocators of our capital in building a robust portfolio of opportunities, as you know, across a diverse group of markets, both animal health, COVID-19 and human health. So – however, one of the cornerstones of building the portfolio has been our opportunistic approach to growing the company. So the S-3 really is in place just to allow us to remain opportunistic, while maintaining financial flexibility as future business opportunities may arise. So I wouldn’t take the fact that we have an ATM in place, something that would be used, unless there’s an opportunity to do so that makes sense for shareholder value. So it seems to give us flexibility and it seems to be, we believe, from a variety of bankers, not just Jefferies that had been pursuing us for, I don’t know, several quarters, that it was a smart thing to put it in place not necessarily that we have to use it.

John Vandermosten

Analyst

Okay, great. Yes, it wasn’t that long ago when you guys were actually buying stocks. So my sense was that it’s just there for a need that arises unexpectedly perhaps. And – well, thank you, Mark, and thank you, Ping, for taking my questions.

Ping Rawson

Management

Thank you, John.

Operator

Operator

We have a question from Ahu Demir, NOBLE Capital. Please go ahead, sir.

Ahu Demir

Analyst

Thank you very much for taking my questions, and congrats on another successful quarter. I want to ask my first question on the partnership portfolio. How many ongoing pharmaceutical partnerships do you have? And in terms of Sanofi, if they decide not to carry or not to advance the C1 technology, do you plan to disclose the data from that project? Can you do that based on the partnership terms?

Mark Emalfarb

Management

Yes. First of all, let me let Matt sort of answer the question, because he is the business development guy and then I can chime in. Matt, do you want to pick that one up?

Matthew Jones

Analyst

Yes, sure. Ahu, so we obviously have a number of collaborations. As Mark already mentioned, we don’t list all the names. But the important thing is that for each of those, they are all trying to enable different kinds of conversations. We’re not a one-trick pony, right? So it’s great that COVID has put us in conversation, too. We really believe very passionately that we can make a massive difference here, massive difference here, and we’re very embarked on those programs. The wider human health programs are a series of fully funded R&D collaborations with a number of top 25, top 50 global pharma companies. Under those agreements, we expressed different types of amino acid sequences, compounds and we look forward to reporting where we can. Your question on Sanofi around how we promote or publish certain data sets, that’s the conversation that we have with our partners. Where it makes sense to stakeholders on both sides, we look to do that. Where there’s a regulatory filing in the near future, we would look to do that then, of course, and we are encouraging these kinds of discussions. We have not just big pharma, who – as you’ll appreciate, I’m naturally very conservative or very cautious with this sort of announcement. But as Mark said in his opening statements, a number of biotech companies are also very familiar with C1. And, of course, it’s impossible to guess on this call which of those data we might agree to jointly publish. What we can say is that, from a previous PEGS conference, certainly, if you passed the – did publish and present on our influenza data and that’s obviously very powerful, showing – shows very powerful efficacy from the C1 expression. And so there are times where big pharma chooses to do that for certain reasons, but it’d be wrong of me to sort of perhaps second-guess that. We’re not distracted always though by that. We’re focused on finding more collaborations with human and animal health opportunities. That’s not just vaccines. But, of course, as Mark said earlier, that’s the big part of what we’re doing at the moment with our research collaborations. And quite rightly so, there’s a massive unmet need here that C1 can fulfill. But we’re focused on widening those conversations with biotechs, with pharmas and also associations, including government-granted academic institutions and foundations, all of whom need to find a powerful, fast, cheap expression system to really reduce the cost of goods and to deliver these unmet needs. And that’s really where C1 plays most strongly, and we look forward to participating more where we’re allowed to.

Mark Emalfarb

Management

And to pick up, Ahu, to be honest with you, we have a multitude of opportunities besides the ones that we’re involved now that we believe are going to come in by the end of the year and if not, Q1. But I’m pretty confident there’s two or three or more. I mean, some of those are in the top 10, again, and some have been back to look at it. We’re still waiting for Sanofi. As we mentioned earlier, they have the pandemic. They’re involved in that. Now it’s summertime break in Europe, anybody that’s familiar with that. But we have ongoing discussions with them on which potential molecule or molecules they might have us try to make and bring those forward. So we were very successful in expressing those proteins in that program. And now it’s just a matter of what products they may or may not fit their portfolio at what time. And they’re evaluating that now and having those discussions. And we expect them to come back to us when summer break sometime, let’s say, I would say now would be late Q3, early Q4. We hope to get some answer from them on how and what to move forward in that program there. And we have a variety of other big pharma companies and small biotechs. I would say just stay tuned. There’s a lot going on. And the pandemic, not just for COVID-19 and vaccines. But it’s opening the doors and the eyes of people on the weakness in the biomanufacturing process. And a lot of people are now recognizing that there is a need to change and it’s speeding the adoption and use. And we’re seeing that sort of dribble down into the pharmaceutical industry as well and – where people are now being, I think, more amenable to change.

Ahu Demir

Analyst

Thank you, Matthew and Mark, for clarifying that. My follow-up question will be on the corona vaccine side. You currently have five collaborations and that’s expected to expand perhaps. I was wondering if you have any in-house efforts to develop any of those vaccines. And also, at what stage are these collaborations? And when do we expect to see any data? Would it be end of this year? Or are we looking more of the next year timeline?

Mark Emalfarb

Management

Well, first of all, the Israeli IIBR and the European – those are involved – or deeply involved at our C1 platform and it’s also our gene sequence that’s being used there. So we have a much deeper involvement than we do, for example, in the case of Ufovax, where it’s their gene sequence and we’re just the expression host. And, of course, with the Frederick National Lab and NIH and the Vaccine Research Center in infectious disease, those are their gene sequences. But as I mentioned during the call, we had very, very good preliminary data that came out of the mice trials. We’ve done other in vitro experiments. The IIBR has done in vitro experiments, other people who reported in Nature magazine on the receptor-binding domain on the SARS-CoV-2 spike protein, and we are seeing good results. And so we sent samples of the – of what we would call our own vaccine candidate, the RBD-expressing C1, because it’s such high levels to the Frederick National Laboratory, for the VRC and them to actually explore and look at against candidates they already have, candidates we’re producing for them and compare that, because we actually think that, that product is the right product, the right vaccine candidate for the right efficacy. And we can make a lot of it very quickly, very cheaply, globally in flexible commercial scale. So we believe that, that product itself will get advanced one way or another from maybe one or multiple of the people that we’re already working with. And as we mentioned, we’re in discussions with others about expanding that. I think people have to realize that this coronavirus pandemic isn’t going away. And some of the early players maybe picked their own genes. They put it into their systems. They may not give the same potency, and they, for sure, can’t make the same quantities at the same cost. So we’re feeling pretty good about where we sit and some of the opportunities that we’re working on in addition to the ones that are already public. And maybe, Ronen, you want to talk about that at all or give a little insight?

Ronen Tchelet

Analyst

Yes. Hi. Yes, I think that what we are having now is the antigen that we developed, the RBD of the spike protein. And more that we’re developing, we see that we’re having good results and we continue to qualify it and hopefully that it could be ready for next steps. So now we are doing animal studies. And so far, the interim results show good results. And we are looking forward to continuing with this effort and qualified to the further steps. And so far, we think that what we see is that the RBD that was produced by C1, giving high productivity and so far, good quality. So we are really looking for – to see how it will be actually developed further. And we hope that other companies also will realize the benefit of C1. And this is where we are now and we are quite excited about what we see so far. But obviously, this is not the end of the road yet.

Ahu Demir

Analyst

Okay. Thank you very much for taking my questions.

Operator

Operator

We have a question from [Robert Smith, Center for Performance Investments] [ph].

Unidentified Analyst

Analyst

Good afternoon. Thanks for taking my question. So yes, Mark, I thought that IIBR actually was into hamster studies already. That was not true?

Mark Emalfarb

Management

Well, the IIBR is advancing, at the current moment, two different vaccines. They have a viral vaccine and they have the C1 vaccine. And from our understanding, they initially started out with a viral vaccine and they may carry that forward along potentially with our own vaccine. But we can produce, from what the IIBR is reporting to us, dramatically higher amounts, obviously, much quicker, much cheaper and can satisfy the population of Israel much faster, as well as obviously extra doses of vaccines that potentially they may or may not want to produce for their allies of theirs. So that’s what they did initially in hamster models. And so that’s probably where you’re somewhat confused there. Right now, with the C1 – the viral vaccine or mRNA are quicker to get up and running, but they may not be as potent and you certainly can’t make them in the quantities or the cost and the flexibility that you can with C1.

Unidentified Analyst

Analyst

I follow. Thank you for the clarifications. So in earlier calls, you said you expected some decisions by Sanofi in the nearer term. So where are we with that?

Mark Emalfarb

Management

Yes. As I mentioned earlier, we have had discussions with them. They’ve expressed interest in moving forward. And with the pandemic and summer break, if you’ve ever done business in Europe, okay, even in a pandemic, they take those breaks. And so they’re hopefully going to come back to us, we think, sometime in Q3. It might stretch out in Q4, could even stretch further, with one or more candidates that they want to move towards not just in R&D, but if C1 is chosen and we can produce that candidate into the clinic potentially and to commercialization. So the experience and the success that we had in the multiple types and classes of proteins we expressed to trying to figure out what candidates they have in their pipeline that might fit best and how and when to use C1 to potentially move that towards a clinical trial or preclinical and clinical trials towards commercialization. So we’re still very hopeful that we’re going to get one or more of those potential candidates into C1 moving forward from Sanofi.

Unidentified Analyst

Analyst

Yes. Is there a possibility of – with one of the collaborations to have a vaccine product before the end of the year? Or is the first quarter of 2021 more realistic?

Mark Emalfarb

Management

Well, we – it’s very difficult, because we don’t control the timeline of these things and what they’re going to do and what decisions they’re going to make. But in any case, we certainly aren’t going to have our own vaccine out as a final product with any of those parties from a commercial standpoint, because they got to go through clinical trials. And those certainly won’t be done by the end of this year or in the – even middle of next year at the earliest.

Unidentified Analyst

Analyst

Okay. All right. Thank you very much. Good luck going ahead.

Mark Emalfarb

Management

Thank you.

Operator

Operator

I’m showing no further questions at this time. And I will now turn the call back over to Mr. Emalfarb for closing remarks. Please go ahead, sir.

Mark Emalfarb

Management

Right. Underpinning the many accomplishments we’ve discussed today is a highly collaborative and coordinated effort, both among our employees and our scientific and business partners, and I want to thank all of them for their extraordinary efforts during these difficult times. Our goal remains to cost-effectively enable the development and manufacture of biopharmaceuticals, thereby making medication more affordable and accessible globally to all. We believe that our industrially proven C1 gene expression platform, which is faster and more efficient than many of the other platforms, including baculovirus and CHO, this will help us and our collaborators achieve our respective goals. Thank you, everyone, for dialing in today, and we appreciate your ongoing support and stay safe.

Operator

Operator

Ladies and gentlemen, this concludes today’s teleconference. You may disconnect your lines, and thank you for your participation.