Dyadic International (NASDAQ:DYAI), a global biotechnology company, reported a strong financial performance in Q3 2024, with revenues surging to approximately $1.958 million, a significant increase from $397,000 in the same period last year.
The company's strategic focus on licensing and product commercialization, particularly in the high-value areas of recombinant human albumin and vaccines for infectious diseases, has been a key driver of growth.
CEO Mark Emalfarb and CFO Ping Rawson provided insights into the company's progress and financial health during the earnings call on November 12, 2024.
Key Takeaways
- Q3 revenue increased to approximately $1.958 million from $397,000 year-over-year.
- Significant milestone of $1 million from a partnership with Proliant Health & Biologics for recombinant serum albumin.
- Advancement in collaborations with major pharmaceutical firms and nonprofit organizations.
- Successful Phase I clinical trial for a C1-produced protein, and over 15 fully funded vaccine and antibody projects underway.
- Financial health remains strong with $10 million in cash and investments as of September 30, 2024.
Company Outlook
- Dyadic plans to commercialize recombinant lactoferrin and beta-lactoglobulin, with sampling beginning in Q4 2024.
- Expansion of bio-industrial enzyme pipeline for sectors like nutrition and biofuels.
- Aims to establish a strong foothold in specific markets where it holds a competitive edge.
Bearish Highlights
- The net loss for the quarter was $203,000, although this is down from $1,614,000 a year prior.
Bullish Highlights
- The company's C1 platform has expressed multiple vaccine antigens, including those for COVID and Mpox.
- Dyadic has initiated over 15 fully funded vaccine and antibody projects, indicating robust R&D activity.
- The company has a competitive advantage with higher productivity yields, particularly in industrial enzymes.
Misses
- Research and development expenses decreased to $460,000, indicating a potential slowdown in R&D intensity.
Q&A Highlights
- The company highlighted the demand for recombinant products like transferrin and alpha-lactalbumin, noting the growing shift towards recombinant alternatives in therapeutics and cultured meat.
- The total addressable market for the company's products is substantial, with significant segments being recombinant.
- Dyadic's royalty rates vary by segment and application, with some profit-sharing arrangements enhancing market access and cost efficiency.
In conclusion, Dyadic International's Q3 2024 earnings call revealed a company in a strong financial position, making significant strides in product development and commercialization. The company's strategic partnerships and focus on high-growth areas in the biotechnology sector have positioned it well for continued success.
Dyadic's commitment to leveraging its proprietary protein production platforms and expanding its pipeline of products promises to drive future revenue growth and market share expansion.
InvestingPro Insights
Dyadic International's recent financial performance and strategic initiatives are further illuminated by key metrics and insights from InvestingPro. The company's market capitalization stands at $33.31 million, reflecting its current position in the biotechnology sector.
One of the most striking InvestingPro Tips is that Dyadic has seen a significant return over the last week, with a 7.61% price total return. This aligns with the positive Q3 2024 earnings report and could indicate growing investor confidence in the company's direction.
Another relevant InvestingPro Tip highlights that Dyadic holds more cash than debt on its balance sheet. This corroborates the company's reported strong financial health, with $10 million in cash and investments as of September 30, 2024. This solid financial footing provides Dyadic with the flexibility to pursue its ambitious R&D and commercialization plans.
The revenue growth data from InvestingPro is particularly noteworthy, showing a remarkable 393.0% quarterly growth in Q3 2024. This exceptional increase aligns perfectly with the reported surge in Q3 revenue to $1.958 million from $397,000 year-over-year.
It's worth noting that while Dyadic is showing strong revenue growth, the company is not yet profitable over the last twelve months, as indicated by another InvestingPro Tip. This is consistent with the reported net loss in Q3, albeit significantly reduced from the previous year.
For investors seeking a more comprehensive analysis, InvestingPro offers 6 additional tips for Dyadic International, providing a deeper understanding of the company's financial health and market position.
Full transcript - Dyadic International Inc (DYAI) Q3 2024:
Operator:
Operator: Good evening, and welcome to Dyadic International Q3 2024 Conference Call. Currently, all participants are in a listen-only mode. Following management’s prepared remarks, there will be a brief question-and-answer session. As a reminder, this conference call is being recorded today, November 12, 2024. I would now like to turn the call over to Ms. Ping Rawson, Dyadic's Chief Financial Officer. Please go ahead.
Ping Rawson: Thank you. Good evening, and welcome, everyone, to Dyadic International's Q3 2024 Conference Call. I hope you have had an opportunity to review Dyadic's press releases announcing financial results for the quarter ended September 30, 2024. You may access our release and Form 10-Q under the Investors section of the company's website at dyadic.com. On today's call, our President and CEO, Mark Emalfarb; and our Chief Operating Officer, Joe Hazelton, will give a review of our third quarter 2024 business and corporate highlights and provide a commentary on the strategic direction of the business. I will follow with a review of our financial results in more detail. We will then hold a brief question-and-answer session. 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 duty to provide updates to its forward-looking statements, whether because of new information, future events or otherwise. Participants are directed to the risk factors set forth in Dyadic's reports filed with the SEC. It is now my pleasure to pass the call to our CEO, Mark Emalfarb. Mark?
Mark Emalfarb: Thank you, Ping. Welcome, everyone, and thank you for joining Dyadic's Q3 2024 conference call. We are excited to discuss how our business strategy centered on near-term licensing and product candidates has strategically positioned Dyadic to swiftly take advantage of current and upcoming opportunities. Our dedicated focus on achieving multiple revenue streams and significant milestones through commercialization of products, technology licensing, fully funded collaborations, advancing our internal and external pipelines are yielding tangible results. These third quarter achievements strongly highlight Dyadic's commitment to harnessing the full potential of our proprietary Dapibus and C1 microbial protein production platforms. These innovative technologies are the foundation for driving, both immediate and sustainable revenue, particularly through the commercialization of alternative proteins targeted for high-value applications, such as recombinant human albumin, transferrin and DNASE-1. At the same time, we're laying the groundwork for substantial mid- and long-term growth in human and animal health markets. This dual-track strategy enables Dyadic to capitalize on near-term milestones, generating license revenue and achieving significant progress in product development by applying our Dapibus platform to develop and produce enzymes and proteins to help address complex and evolving needs in health, nutrition and wellness, such as dairy proteins, including alpha-lactalbumin and others. Simultaneously, our biopharmaceutical pipeline powered by our C1 platform holds significant opportunity. For example, we are collaborating with ViroVax to develop potential vaccines for infectious diseases, such as bird flu and Mpox. Additionally, our collaborations with two of the top 10 pharmaceutical companies and a leading biotech company have yielded progress in producing several commercially relevant proteins, such as an antibody targeting digestive health and multiple antigens in large infectious disease markets such as HPV, RSV and HIV. We are advancing collaborations with leading nonprofit organizations and governmental agencies to further accelerate the adoption of our C1 protein production platform due to the many advantages the C1 cell platform offers such as speed of development and manufacturing, high productivity, cost efficiency and flexibility of use in diverse applications of vaccines and treatments for infectious and other diseases that can be produced in greater quantities, more affordably, more patients -- for more patients in developed and developing countries. As we continue advancing our efforts across all segments, we remain deeply committed to delivering sustained value to our investors and partners. Dyadic is poised, not only to meet the challenges today, but to shape the health, wellness and nutrition solutions of tomorrow, positioning ourselves as leaders in the global protein production of enzymes, alternative proteins and biopharmaceutical sectors. I will now turn the call over to our Chief Operating Officer, Joe Hazelton, to provide an update on our business results for the third quarter. Joe?
Joseph Hazelton: Thank you, Mark. Our collaborations in alternative proteins and biopharmaceuticals demonstrate the remarkable versatility and scalability of our platforms, underscoring Dyadic's ability to deliver consistent, high-quality results across various applications. Through these partnerships, we're producing recombinant proteins like human serum albumin for cell culture media and alpha-lactalbumin for nutritional uses, meeting critical health and wellness needs and reinforcing Dyadic's market position. Our platforms also enable efficient production of complex antigens and antibodies, essential for developing vaccines and therapeutics for both animal and human health. These innovations generate immediate and sustained revenue, positioning Dyadic for substantial future growth as we expand into high-demand and high-value markets. By diversifying our capabilities and product offerings, we're advancing toward our vision of becoming a leader in alternative protein production and biopharmaceutical manufacturing, creating continued value for our shareholders, partners and consumers. In the third quarter, we demonstrated that our strategy of focusing on high-value alternative protein products is both viable and achievable in the near-term without the costly and lengthy development seen with human and animal therapeutics and vaccines. Within the alternative proteins market, we are refining our approach by targeting three key segments: life science, food and nutrition and industrial recombinant proteins and enzymes. The life science category, our highest value and highest margin segment includes products for cell culture media, diagnostics, cell and gene processing and vaccine production. The majority of these products can be tailored for various markets with Dyadic's initial life science offerings being research-grade products for nonhuman research use. Beyond collaborations, such as our recent work on recombinant serum albumin, we are preparing to launch our own research-grade products, including RNase-free DNASE-1, which is used in molecular biology. In June, we announced the development and commercialization partnership with Proliant Health & Biologics, a leading supplier of purified proteins for diagnostics, nutrition and cell culture markets. In the third quarter, Dyadic received $1 million in access and milestone fees with an additional $500,000 expected upon reaching a defined productivity threshold from this agreement. The partnership's initial focus is on the commercialization of recombinant serum albumin -- human serum albumin for diagnostics and other applications, with the first product anticipated to launch in the first half of 2025. This $6 billion serum albumin market represents a significant opportunity as Dyadic will share Proliant's profits from the sale of animal-free recombinant albumin products. To broaden Dyadic's strategic focus, we're expanding our portfolio of life science research-grade recombinant products in 2025. We have completed the development of DNASE-1, an RNase-free enzyme with demonstrated analytical comparability to reference standards, obtained a certificate of analysis and initiated sampling with potential customers. We are now finalizing the manufacturing process and expect to begin accepting preorders in early 2025. Alongside producing DNASE-1 as a product, our business development efforts are actively engaging interested parties for licensing the production strain, creating multiple revenue opportunities from the single product. DNASE-1 is part of a high-value, high-demand segment of enzymes essential for DNA and RNA manipulation in molecular biology. We are expanding our development efforts in this segment beyond DNASE-1 initially for research-only use with plans to produce clinical-grade versions for regulated markets in the future. We have developed cell lines for four additional products beyond DNASE-1 in the research-grade segments of DNA and RNA polymerases, DNA ligases and RNase inhibitor products with sampling efforts anticipated by the late fourth quarter 2024 or early first quarter 2025, while we finalize comparative analytics and optimize strain productivity and quality. By broadening our molecular biology portfolio, Dyadic is positioning itself to penetrate the $900 million DNA/RNA enzymes market. Our second primary focus within life science alternative proteins is on cell culture media, essential for in vitro cell growth across research, nutrition and pharmaceutical applications. These media supply the nutrients hormones and growth factors needed for healthy cell proliferation. Recently, we accelerated the development of our recombinant transfer and strain, achieving higher productivity than initially expected. With the certificate of analysis completed, we've begun sampling and application testing for lab-grown meat and other markets ahead of schedule. This progress has captured the interest of key collaborators in the global cell culture media market valued at over $4.7 billion in 2023 and expected to grow at a CAGR of 12.5% through 2030. This segment remains particularly attractive for Dyadic with high-value products like growth factors, transferrin and albumin comprising over 95% of media costs with the majority of these products being produced recombinantly. To expand our cell culture media portfolio, we're developing human and bovine growth factors for research and food applications. Our third quarter development and testing efforts have led us to initiate sampling of these products to prospective partners exceeding initial time lines. Within the food and nutrition vertical of alternative proteins, our efforts in the global animal-free dairy products market valued at over $26 billion in 2022 are starting to generate revenue. Using precision microbial fermentation, we're producing animal-free dairy products in response to shifting consumer preferences and health concerns like lactose intolerance. Although, production costs remain high for these products, our expertise in large-scale, cost-effective recombinant protein production positions us to potentially overcome these challenges. Since signing our 2023 agreement to commercialize non-animal dairy-derived enzymes, we've received a $600,000 upfront payment and surpassed our first milestone with an additional $425,000 for achieving target yields in the third quarter. Our partner aims to launch a non-animal dairy enzyme in the first half of 2025 with development of the second enzyme ongoing. Additionally, interest remains strong in our recombinant alpha-lactalbumin product with ongoing negotiations with multiple end product and precision fermentation companies who have received samples. We recently finalized the certificate of analysis for bovine alpha-lactalbumin while simultaneously developing a human version of alpha-lactalbumin in the third quarter, targeting research-grade applications, expanding the potential value of our alpha-lactalbumin franchise. Meanwhile, we're advancing efforts to commercialize recombinant lactoferrin and beta-lactoglobulin with sampling set to begin in the fourth quarter. Rounding out our alternative protein segments, we're expanding our pipeline of bio-industrial products with enzymes for industries like nutrition, biofuels and biorefining. In partnership with Fermbox, we developed a cellulosic enzyme for biofuels, currently being evaluated by potential customers. Additionally, Dyadic has designed enzymes initially targeted at the pulp and paper sector with promising applications in biogas and biofuel production. We aim to commercialize these products within the next 12 months to drive revenue growth. As Mark outlined earlier, our dual strategy emphasizes near-term revenue in alternative protein and builds mid- to long-term value in human and animal pharmaceuticals. Following the successful completion of our first-in-human Phase I study for a C1-produced protein, we're receiving significant interest from academia, government, industry and nonprofits. Since early this year, we've initiated over 15 fully funded human health vaccine and antibody projects, including partnerships with two top 10 pharmaceutical companies. These programs span diverse disease areas, underscoring Dyadic's ability to produce, both standard and complex molecules. Our C1 platform has successfully expressed multiple infectious disease vaccine antigens, including COVID, avian and seasonal influenza, Mpox, HPV, HIV, malaria, RSV and others. We also delivered three monoclonal antibodies for evaluation as neutralizing agents, all of which demonstrated similar activity to those produced in CHO cells in testing by our third-party collaborators. The spread of the H5 bird flu has further heightened interest from human and animal health companies. We partnered with ViroVax LLC to develop an adjuvanted avian influenza or bird flu ferritin nanoparticle vaccine. Preliminary animal studies suggest strong immune responses, positioning this vaccine as a potential option for both human and animal applications. We've actively shared these findings at medical conferences and have made a number of presentations to industry, government agencies and nonprofits to support our engagement with interested partners. To address the Mpox formerly monkeypox outbreak that was recently declared a public health emergency of international concern by the WHO, we again partnered with ViroVax LLC, achieving a 4.5 gram per liter productivity in seven days of our Mpox ferritin nanoparticle vaccine antigen with ViroVax targeting preclinical studies for the Mpox vaccine later this quarter. Multiple applications for grant funding from leading nongovernmental organizations in collaboration with the Fondazione Biotecnopolo di Siena and others for a variety of vaccine antigens and antibodies have been submitted to help advance our efforts in the human health segment. Finally, the animal health segment continues to advance with key partners, including Phibro Animal Health (NASDAQ:PAHC). In light of the bird flu outbreak, we've intensified business development efforts focused on recombinant vaccines for pandemic preparedness, including our collaborations with the C1-produced H5 bird flu ferritin nanoparticle antigen that's being evaluated for potential use in poultry and cattle vaccines. We remain focused on financially disciplined product opportunities, fully leveraging Dyadic's technology and expertise. Our entire team is committed to driving near-term revenue growth in alternative proteins while building sustained value in animal and human health markets. With that, I'll now turn it over to our CFO, Ping Rawson, to cover our financials.
Ping Rawson: Thank you, Joe. Thank you, everyone, for joining our call today. I will now go over our key financial results for the quarter ended September 30, 2024, in more detail. You can find additional information in our earnings press releases and Form 10-Q, which we filed earlier today. Revenue for the quarter ended September 30, 2024, increased to approximately $1,958,000 compared to $397,000 for the same period a year ago. The increase is driven by the license revenue of $1 million from Proliant and a success fee of $425,000 from Inzyme. Cost of revenue (ph) and development revenue for the quarter ended September 30, 2024, increased to approximately $396,000 compared to $106,000 for the same period a year ago. The increase in cost of research and development revenue was due to the increasing number of collaborations conducted in 2024. Research and development expenses for the third quarter of 2024, decreased to approximately $460,000 compared to $716,000 for the same period a year ago. The decrease reflected the winding down of activities related to the company's Phase I clinical trial of DYAI-100 vaccine candidate completed in February 2023 and a decrease in the amount of ongoing internal research projects. G&A expenses for the third quarter of 2024, increased by 1.2% to $1,298,000 compared to $1,282,000 for the same period a year ago. The increase reflected increases in business development and investor relations expenses of $52,000, and other increases of $24,000, offset by decreases in management incentives of $38,000, and accounting and legal expenses of $22,000. Loss from operations for the third quarter of 2024, decreased to $203,000 compared to $1,720,000 for the same period a year ago. The decrease in loss from operations was largely due to the licensing revenue of $1 million received from the Proliant agreement and a milestone payment of $425,000 from the Inzyme agreement, as we mentioned earlier. Net loss for the three months ended September 30, 2024, was $203,000 or $0.01 per share compared to $1,614,000 or $0.06 per share for the same period a year ago. As of September 30, 2024, we have cash and investment-grade securities of $10 million compared to $7.3 million as of December 31, 2023. As we mentioned earlier, the company received a total of $1,425,000 licensing and milestone fees just this quarter alone. With that, we expect our total cash burn for 2024 will be decreased significantly to approximately $4.7 million. With that, I will now ask the operator to begin our Q&A session, after which Mark Emalfarb will provide closing comments. Operator?
Operator: Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] The first question comes from the line of John Vandermosten with Zacks. Please go ahead.
John Vandermosten: Thank you and good evening. I'd like to understand about how the regulatory requirements work for some of these research-grade recombinant proteins. You mentioned several certificates of analysis. And, I guess, is that the only regulatory hurdle you have to pass to be able to sell these?
Joseph Hazelton: Technically, it's -- and John, sorry, this is Joe. A great question. And no, it's not the only hurdle. The manufacturing must be done at an ISO-certified facility as well. So there's no -- I guess, the easy way to think about it, there's no regulatory review done by a regulatory agency that's going to need to be done to launch these products. It mainly has to do with ensuring that your product specs for QA and QC meet the required levels for ISO. That's it.
John Vandermosten: Okay. And I heard you mentioned several of these certificates of analysis. Could you remind me again how many you have? I think you said for -- well, I'll just let you say it. I heard probably at least three, I think, right?
Joseph Hazelton: You're exactly right. We have three. DNASE-1, a bovine transferrin and a bovine alpha-lactalbumin. All three have certificates of analysis with comparative analytics to currently available and commercialized research-grade products. So basically, we look, act and perform the same as what's currently available on the market, which is obviously what we need to be able to launch.
Mark Emalfarb: And those are in addition to two albumin, the albumin as well, right?
Joseph Hazelton: Yes, through the Proliant agreement, before the agreement signed, we did have a certificate of analysis for the bovine and the human albumin as well.
John Vandermosten: Great. Thanks, Mark.
Operator: Thank you. [Operator Instructions] The next question comes from the line of John Vandermosten with Zacks. Please go ahead.
John Vandermosten: Great. Thanks, again. So I want to understand about some of these high-dollar research products and how hard it is to manufacture them. I get the sense that these are kind of small batch and there's no real big advantage to being a larger producer of these. Is that correct? And, I guess, just help me understand how the process works to produce these research-grade products?
Joseph Hazelton: It honestly -- John, this is Joe again, and thanks for the question. It honestly differs by the market. So there are high-value, high-volume markets like serum albumin that are both not only high priced, but also you need probably metric tons of this stuff per year. There are other products like DNASE-1 used in vaccine production of mRNA vaccines that aren't necessarily needed in the same quantities, but they're also toxic to most cell lines. So they're extremely difficult to produce in large quantities. You're talking producing in milligrams versus grams. But you're right, the utilization of those is much lower. The key is, how do you improve your margins in those markets. If you can't do it from an upstream and a downstream standpoint, it's very difficult to try to make money in these segments where we have the advantage is, we're able to produce at higher levels and with lower upstream costs and in some cases, lower downstream costs than some of the currently used cell lines like E. coli and baculovirus, sorry. So that's kind of the advantage that we have, being able to produce even small batches at lower cost provides you much more margin flexibility.
Mark Emalfarb: And if I can add a little color, John, to that, maybe as Joe points out and we pointed out in the past, Dyadic does the exact same thing every time we take a gene sequence, whether it's for ourselves, for our own product pipeline for DNASE-1 of these enzymes that Joe has been talking about. But also whether it be albumin or transferrin or these other products or it's an antigen or an antibody, our scientists are trained to insert these genes into these cells, whether it's Dapibus for the nonpharmaceutical proteins or C1 for pharmaceutical proteins to just produce large amounts of volumes in terms of yield. Now, as Joe pointed out, you don't need large yields for some of these like smaller volume items like DNASE-1. But our yields are still significantly higher than the competition. So that gives us an advantage in those cases. So it's all about productivity. And, of course, some markets, you don't need as high productivity as others. In the industrial enzyme business, and we've developed this after three decades for high productivity for speed, for durability, robustness and versatility, and that's now coming out here in spades. And, of course, in the last seven years, where we've modified C1 to knock out proteases, glycoengineering, it just opens up the windows of opportunities in just many directions. But we're doing the same thing every time. We're just taking this hyperproductive cell line with the genetic tools and the scientific prowess to modify them to produce proteins, no matter what the application is.
John Vandermosten: Okay. And one last question for me, if I can. And maybe this is for you, Joe. Can you help me understand more about the market, I guess, between recombinant product and then product from animal product for transferrin and alpha-lactalbumin. What -- in terms of pricing, I guess, and just demand from the market, I mean, what is the market looking for? Do they prefer one over the other?
Joseph Hazelton: I hate to give this answer because I hate it when people do it to me, but it honestly depends on the market. So like alpha-lactalbumin, the current market is dominated by animal-derived. If you're looking in the food space, that's a space that we'll have to do -- I don't want to say significant, we will have to improve the productivity of the cell line to be able to attempt to get to the margins that you can get with a bovine-produced. However, alpha-lactalbumin, both human and bovine as a research-grade material, our current yields put us in the price range or put us in the potential to produce at the price range or lower than how it's being produced today. So, I know it's not a great answer, but it really does depend on the segments you're looking at. Obviously, food has a much lower margin than anything in the research or the pharma space. But at the same point in time, it still is the same thing. You need to have the right potential to decrease margins in these markets. In the research-grade space, you have a little more wiggle room because the products like growth factors. I mean, people spend millions of dollars for probably 2 or 3 grams of this stuff. So there are segments where, you're right, you don't have to produce much. And obviously, you don't even have to sell that much of a discount to make a huge impact for your customers. And they're not just used for food. Cell culture media products are used to grow CHO cells and other cells that are made to make human and animal therapeutics. So that's why they're extremely valuable because those are highly regulated and you have to make them at cGMP, which again drives up your cost. So, anything we can do to lower the cost of those products in the given markets, that's really the name of the game here. But like I said, it's really a market-driven, which is why we're targeting very specific markets where we feel we have a competitive advantage because of our cell line.
John Vandermosten: Okay. And then -- and just on the research side, the reference -- my sense is that, it would be -- they prefer recombinant just because it has fewer contaminants in it. Is that right? I mean, are there any other considerations there? And is that a correct assumption on my part?
Joseph Hazelton: I tell you, you're still going to hate me because it honestly depends on the application. But yes, it drives me nuts when people do that to me, so I apologize. But it honestly does depending on what you're using it for. But you're absolutely right, the advantages of recombinant for the most part are hopefully an easier regulatory pathway because you don't have as much potential for contaminants or viruses that you do from animal sources. At the same point in time, I'm not going to tell you that there aren't some uses for animal-derived products because there are, in some cases, they do work better. Those are becoming more and more limited simply because the technology is obviously improving and the quality of the products produced recombinantly is improving as well. But you are seeing a growth in that sector due to the fact that people do want to move away from animal-derived proteins, especially in the production of therapeutics. So when you're looking at producing mRNA vaccines or recombinant vaccines, the vaccine production usually uses like human serum albumin to stabilize the vaccine. They want to get away from using actual serum from humans. They want to use something that's more reliable, more stable and more consistent. And that's where the recombinant products give you that advantage.
John Vandermosten: Great. Thanks, Joe. Thanks for letting me explore some of those things. Appreciate it.
Operator: Thank you. Next (LON:NXT) question comes from the line of Robert Hoffman with Princeton Opportunity (SO:FTCE11B) Management. Please go ahead.
Robert Hoffman: Thanks for taking the question. I want to piggyback on that a little bit. I mean, you guys have talked about some of the addressable markets that you have. But then, obviously, some are more amenable to your technology, whether it's because you can create a better margin. So, I guess, it's a two-part question. Can you give us an idea of -- if you add them all together, what is the reasonable addressable market for you? Meaning if the market is $1 billion and you think you can get 10%, then it's $100 million. Can you give us a sense of what you think is a reasonable expectation of the addressable market? And then on the assumption that you'll be getting royalties, is it -- are they going to be consistent across all those? Is it going to be in the 5% range or any clarity you can give us on what the royalty rate might be, would be helpful.
Joseph Hazelton: Mark, do you want me to go? You want to...
Mark Emalfarb: I think, yes, you go first. And if I have to add a little color, I will, okay?
Joseph Hazelton: So, Robert, first of all, thanks for the question, and nice to meet you. I'll start with the royalty rate. That does vary. It varies by segment, application and product. So it's not a consistent 3% or 5% or 10% across the board. It will vary depending on the value of the product and the value that we play in that -- in the production as well. For total addressable market, again, I'm going to give you the answer that I hate. It does -- it varies by market. Cell culture media products, the segment that we're currently targeting in alternative proteins for life sciences, that's about a -- or I say, $4.7 billion market, around 60% to 70% of the agents used, so growth factors, transferrin and albumin, around 60% to 70% of the cell culture media agents today are recombinantly produced. So, obviously, you're looking at a big chunk of that $4.7 billion being an addressable segment for recombinant products that we produce. Similar in the DNASE-1 space as well, that roughly that whole DNA ligases, RNase inhibitor products, that's an almost $1 billion segment. Roughly half of that today is recombinant. There are some chemical ways to produce these products that are, in some cases, less expensive as well. But that's -- again, you're looking at $0.5 billion as a potential addressable market for the products that we're looking at targeting in this segment. So there -- you're absolutely right, in food, it's probably a little bit less. So in, let's just say, alpha-lactalbumin. About 10% of the current alpha-lactalbumin used today is recombinant. And honestly, that's simply because it's too expensive to produce and compete with an animal-derived version. In the research space, though, it is -- we're actually able to compete, about 70% of the utilization of alpha-lactalbumin in the research space is recombinantly produced. So that's why I'm saying and I always hate to do that, but it does depend on the market and, obviously, the product. So hopefully...
Robert Hoffman: No, that's very helpful. Thankfully, there's such a thing as a transcript because I couldn't write that fast. So I can go back and look at that. And yes, it's nice to meet you, Joe. Fortunately or unfortunately, Mark and I have known each other for too many years. In terms of royalty, does that -- you threw out three numbers, 3%, 5% and 10%. Is that a good assessment of what the range might be depending on the different products?
Mark Emalfarb: I think that, that's probably nonpublic information. But you can say that certainly, some of those could be in the range depending on what the application is, as Joe pointed out and what our contribution is. But in some cases, it's also not a royalty, it's a profit-sharing. Like with Proliant, it is a profit-sharing, okay? So we're a percentage of the profits. And those numbers could be in those ranges or higher or lower, right?
Robert Hoffman: Well, percentage of profits, we hope it's a little higher.
Mark Emalfarb: Yes. So it just changes depending on the need, how much, let's say, higher yield, higher purity, lower cost, availability. For example, recombinant and albumin, if cultured meat industry took off, and Joe can give you more color on that, there isn't enough bovine albumin that can be produced to even hit a fraction of the market opportunity there. So it's going to have to be some alternative to bovine albumin if they're actually able to sort of break the cost barrier of making cultured meat affordable. Am I right, Joe?
Joseph Hazelton: Yes. Like fetal bovine serum is basically what they use to -- as the albumin source for cultured meat. Well, fortunately or unfortunately, you can't produce enough cows or young cows to get that much blood to supply the market because in a typical like 20,000-liter bioreactor that they use to manufacture the end product or the -- to grow the actual muscle cells, you're looking at about 75% of that tank needs to be filled with albumin. So they just -- there will not be enough to support that market from an animal-derived source. So they will have to -- obviously, they're looking at serum-free alternatives. But when they say serum-free, they actually mean recombinant serum albumin. So they're still using it just hopefully in lesser quantities and not animal-derived. So there's definitely opportunity within that segment, but that one needs some help as well.
Robert Hoffman: And I would assume that...
Mark Emalfarb: Well, I think it's important. When we chose Proliant and they chose us, it's because we have this very, very high-yield upstream in the fermentation and they have a very low-cost downstream, but they also have market access because they've been dealing in this industry for many, many, many years. I think they're either the second or third largest fetal bovine albumin supplier in the world. So they have market access, which we wouldn't have had and had to develop. They have a downstream processing, which is an expensive part of the whole process that's cost advantageous, and we have the high upstream. So it's a marriage made in heaven to some degree, and that's how we look at it.
Robert Hoffman: I can't remember if all of these are exclusive relationships. But on the assumption that some might not be, do you think there's an expression we want to be first or second, but never first? Do you think that once you get adopted by producer A, that producers B, C, D and E will follow or is it -- do you have exclusive so A will either win or not win?
Mark Emalfarb: Well, I think it's both. I think we can have an exclusive where we believe we have the right partner and committed to work together to hopefully, in time, dominate the market if we can or certainly take a significant portion of it. But I think the other point you make, Proliant and the deal we made because of the stature and their breadth and scope and depth of being in the fetal blood albumin market and the cell culture market for transferrin and other opportunities we have, it's woken up a lot of the players that were dancing around us and not making commitments. So I think that's -- and maybe, Joe, you can circle in a little more on that.
Joseph Hazelton: I mean, honestly, I think you hit it, Mark. I think, obviously, it's -- our preference would not be -- our preference would be to have as many opportunities with the same product as possible, doing it nonexclusively that, obviously, we think it's a great strategy. But there are potential opportunities. And just like in the pharmaceutical space, if you're going to hitch your wagon to a pharmaceutical company, you want them to be the market leader in the specific area you're going into. So we obviously try to do what's best for the organization, it'll drive the most value for us.
Mark Emalfarb: Right. And the thing is, Robert, some of these products were potentially like DNASE-1, we're planning on doing both, keeping it and licensing it and selling it as a product. Now that may change if somebody wants to offer us an amount of money that we can't afford to turn down.
Robert Hoffman: Got it. Great. Thanks. Thanks for providing me extra information. Appreciate it.
Operator: Thank you. [Operator Instructions] There are no further questions. I will now turn the call over to Dyadic's CEO, Mr. Emalfarb.
Mark Emalfarb: Yes. I want to thank everyone for joining in tonight. This is a very exciting time for Dyadic in our history. We've transitioned back into the, what we call the non-pharmaceutical industry for the last couple of years, and we've made tremendous progress with the transferrin and the albumin and the DNASE-1 with very, very, very quick back entry into the market. Remember, we had a long history of developing products and enzymes at huge scale, low cost with people like Shell (LON:SHEL) and BASF, and then ultimately, DuPont (NYSE:DD) paid us $75 million. So, in 2024, we refined our corporate strategy to leverage Dyadic's C1 and Dapibus protein production platforms with a focus on driving near-term recurring revenue while building sustainable mid- to long-term value. Our approach centers on three key markets: alternative proteins, animal health and human health. Today's updates showcase the strategy in action, with executed agreements, revenue growth and substantial progress across all these areas, especially within the alternative proteins and the Dapibus platform, which we've just jumped back into in the last few years. We're also pursuing opportunities with our avian influenza and Mpox candidates, actively seeking nondilutive pathways to advance development. We'll keep you updated on our progress in the months ahead. As Joe mentioned, Dyadic is deeply committed to generating near-term revenue and growth through innovative solutions and accelerated commercialization. By expanding our C1 and Dapibus platforms across alternative proteins, animal health and human health, we are at an exciting juncture uniquely positioned to capitalize on current and emerging opportunities. I want to thank you for joining today's third quarter 2024 conference call, and we look forward to sharing more updates on our commercial and scientific milestones in the coming months. Stay tuned for more from Dyadic.
Operator: Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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