CDXS - NASDAQ

Greetings. Welcome to Codexis, Inc. Reports Fourth Quarter and Fiscal Year 2025 Financial Results Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. Please note this conference is being recorded. I will now turn the call over to Georgia Erbez, Chief Financial Officer and Chief Business Officer. Please go ahead.

Thank you, operator. With me today are Dr. Alison Moore, Codexis, Inc. President and CEO, and Britton Jimenez, Senior Vice President, Sales and Marketing. During this call, management will make a number of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including our guidance for 2026, revenue, anticipated milestones including product launches, facility expansions, technical milestones, and public announcements related thereto, as well as our strategies and prospects for revenue growth, path to profitability, and successful execution of current and future programs and partnerships. To the extent that statements contained in this call are not descriptions of historical facts, regarding Codexis, Inc. are forward-looking statements reflecting the beliefs and expectations of management as of the statement date, March 11, 2026. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors that are, in some cases, beyond Codexis, Inc.’s control and that could materially affect actual results. Additional information about factors that could materially affect actual results can be found in the Codexis, Inc. filings with the Securities and Exchange Commission. Codexis, Inc. expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. I will now turn the call over to Alison.

Thank you, Georgia, and thanks everyone for joining. At Codexis, Inc., our mission is to generate manufacturing solutions using biocatalytic enzymes. Building on our history of innovative enzymes, and our established relationships with the biopharmaceutical industry, we are now focused on RNA medicine. We have developed the ECOsynthesis manufacturing platform, which is short for enzyme-catalyzed oligonucleotide synthesis, and has been developed to address many of the challenges experienced with the current siRNA production technology. The number of siRNA medicines in development are growing at a rate of 5% to 10% per year, and current production technologies will not be able to keep up with demand. The impact of these powerful new therapies may be compromised if they cannot be produced at scale. It is not a medicine if you cannot make it. The total addressable annual market for production technologies in five years is estimated to be $2 billion, and we intend to establish Codexis, Inc. as a key technology provider in this market. Let's talk about how we are doing that. Last year was pivotal in both the focus and momentum of the company. We achieved a number of important milestones in 2025 in platform performance and industry engagement, demonstrating tangible and significant interest from our customers who are all invested in making powerful siRNA therapeutics, and demonstrating that we are at the forefront of biocatalytic enzyme innovation by developing technologies that can improve large-scale manufacturing of oligonucleotides, and potentially even deliver superior therapeutic asset activity. We reached an important technical milestone in delivering our platform, having synthesized 10 grams of a commercially relevant siRNA using full sequential ECOsynthesis. Importantly, we shared detailed product quality data from this synthesis demonstrating no quality barriers related to our production technology. We are continuing to scale up the production in 2026, currently operating at 100-gram scale in our Eco Innovation Lab, and heading toward half a kilo scale by the end of the year. In addition, we had a client utilize our ligase to manufacture a 3-kilogram batch of siRNA, a tremendous achievement in chemoenzymatic production, an important growth sector of our business. In terms of building a robust supply chain to support our ECOsynthesis, we made significant progress in production infrastructure. Our ECOsynthesis process involves a suite of purified enzymes. To enable efficient, high-quality supply of these enzymes, we have modernized our non-GMP production capability in Redwood City and achieved ISO 9001 certification. This certification provides confidence to our customers that we are operating under a particular quality standard. This milestone was reached in 2026, and since then, we have passed a facility and quality management system inspection by a large pharmaceutical customer, readying Codexis, Inc. for ECO enzyme supply. With respect to GMP production capability, we are fully engaged in our capital project to retrofit our new GMP plant that was leased in 2025. We will begin construction in the second half of this year and expect it to be fully operational by the end of 2027, further enabling the adoption of the ECOsynthesis platform and serving our customers with GMP siRNA. Innovation is a cornerstone of our company and our culture. In 2025, we introduced a new feature of our ECOsynthesis platform, which is the ability to generate siRNA with specific stereochemical control. We presented our first data demonstrating stereoisomer resolution at TIDES U.S., and we are building the ability to control stereoisomer configuration at both the 3’ and 5’ ends of the siRNA molecule. In addition, we are exploring the biological impact of this control, and believe this could be a tremendous asset to those customers who seek ways to improve the potency and purity of their product. We will always be striving to lead the industry in innovations that are meaningful and directly relevant to the needs of our customers. On the commercial front, at the start of 2025, our goal was to market our ligase and full ECOsynthesis products and services by contracting with a broad range of customers in siRNA product development. We saw engagement from a range of innovators, from large pharmas to emerging growth biotechnology customers. Britton will give a full update on our commercial activities later in the call. Our goal at the beginning of 2025 was to have one CDMO arrangement signed in 2025. We surpassed that goal by signing three agreements, one each with Bachem, Nitto Avecia, and Axolabs, highlighting the motivation from major providers who clearly understand the current limitation of standard solid-phase chemical processes. Each of these partnerships is initiated with feasibility work in our own labs using a specific therapeutic asset sequence. In 2025, we returned our heritage small-molecule biocatalysis business to a healthy profit margin, and have seen stabilization in revenue. The pipeline of drugs in late-stage clinical studies remains robust, and should fuel growth in this area for at least the next three to five years. This remains an important part of our business as it supports the investment that we are making in ECOsynthesis. Operationally, we paid close attention to our costs and made the hard decision to realign our work in the fourth quarter. The savings we expect to realize from these efforts will partially offset the cost of our GMP facility, allowing us to make this important investment with minimal increase in our cash burn. Georgia will give you a more detailed description of our financial expectations. We ended the year in a strong cash position fueled by the $37.8 million technology transfer agreement we signed with Merck in the fourth quarter, and we expect our current cash balance to fund operations and capital expenditures through 2027. It is remarkable that in just a short time we have moved enzymatic siRNA synthesis from an exciting idea to a reality. We are proud of the progress we have made in 2025 to achieve liftoff of the ECOsynthesis platform. We look forward to showing our customers and investors additional tangible proof of the value of the technology in 2026. To walk you through our commercial achievements and plans for 2026, let me turn it over to Britton.

Thanks, Alison. Broadly speaking, 2025 was the year we moved our ECOsynthesis manufacturing platform from an attractive concept to a promising and viable business. 2025 was also the year where our platform advanced from technical feasibility to being capable of supporting preclinical development as our customers progress towards IND and other regulatory submissions. And now I want to share more details on our revenue drivers for 2026. We spent 2025 building and refining our sales messaging and filling the customer pipeline for our ECOsynthesis services platform. We have 55 opportunities in the sales pipeline with 40 individual companies, demonstrating strong continued interest in our ECOsynthesis technology. The industry knows there needs to be a change, and we intend to be the best option for them, whether they are a drug innovator or a CDMO. I would like to spend a moment breaking down the stages of our agreements with innovators, what they entail, and offer a plan for how they could evolve. Our arrangements with CDMOs are slightly different, and I will review those as well. We announced last week a contract with an emerging biotech company. Under this contract, we will supply the innovator with 50 grams of siRNA material made using our ECOsynthesis manufacturing platform. To clarify, this is fully enzymatic synthesis of a siRNA drug substance. Once we deliver the material, they will be able to perform preclinical testing on the asset. Upon meeting the goals of this testing, the innovator plans to use our process to move their drug candidate into clinical studies. This is an exciting proposition for us, as it is the first time we have a line of sight to having a drug made from the ECOsynthesis platform move into human studies. Financially, this low 7-figure contract is fairly evenly split between services and product revenue, and is expected to be completed over the next 12 months. This contract is the prototype of how we enter into evaluation agreements with our customers. Once the customer decides to move their drug candidate forward, we enter into a new multi-year agreement that will incorporate licensing fees, milestone payments, as well as a clinical supply agreement. The dollar value of these contracts will vary based on the size of the clinical trial and the amount of material we must produce to meet the customer's needs. If the product is developed successfully, we will enter into a commercial supply arrangement. We will continue to provide updates throughout 2026 on examples of these types of contracts. We have also created relationships with CDMOs, all of which are currently in the technology feasibility assessment phase. Once this phase has been completed, we expect the relationship to move to an adoption phase where we will transfer our production-scale process to their facility. We expect to work under a commercial agreement that would consist of upfront licensing fees plus referral revenue-sharing arrangements. We expect referrals to be bilateral. We will refer our customers to our preferred CDMOs and likewise, our CDMO partners will refer customers to us who are looking to improve their manufacturing process. Our small-molecule biocatalysis business remains stable and profitable. As we mentioned on our last earnings call, we support 14 programs in late-stage clinical development. We have had data readouts on three of those studies, two of which were positive. Our customers are in the process of seeking commercial approval for those programs, and we are already seeing activity in preparation for supporting commercial launch. As we mentioned late last year, this is evidence that our historical business is starting to show sustained growth again for the next few years. We still have additional opportunities to add to this late-stage pipeline, and we will continue to service the needs of our customers who seek value-added enzymatic solutions to their drug manufacturing activities. As Alison mentioned earlier, we are focused on enabling technology innovation in the oligonucleotide market. We are already having conversations with customers about how to employ stereoisomer control to deliver improved productivity and potentially improved potency. With further technological development and demonstration of the importance of this approach, this has the potential to be an important offering in our commercial portfolio. In addition to product and service sales, I want to take a moment to note Codexis, Inc.’s rich history in business development and technology licensing. One of our strengths is identifying innovative ways for our customers to benefit from our technology. Whether it is exploring fields outside our core focus, or out-licensing our CodeEvolver technology, we have had a long practice of signing licensing deals. The agreement we signed with Merck late last year is evidence of the importance of this strategy, having provided us $38 million of non-dilutive capital. We remain committed to this practice and intend to sign a licensing-type deal in 2026. I hope you can appreciate the feeling of excitement we have for our prospects in 2026 and beyond. We are aligned behind our ECOsynthesis technology and are energized to truly make 2026 a demonstrable success. With that, I will now turn the call over to Georgia for a discussion of our financial results for the fourth quarter and full year 2025.

Thanks, Britton. Good afternoon, everyone. Today, I will provide a brief overview of our financial results here on the call and invite you to review our 10-Ks filed today for a more detailed discussion. Total revenues were $38.9 million for 2025, compared to $21.5 million in 2024. The increase was primarily due to the Merck Technology Transfer Agreement executed in 2025. We do expect a small amount of revenue under this agreement to be recognized in 2026. For the year ended 12/31/2025, revenue was $70.4 million compared to $59.3 million for the prior year. Product gross margin was 64% for 2025. For the year ended 12/31/2025, product gross margin was also 64% compared to 56% for the prior year. During both the three-month period and the full-year period, the increase was primarily driven by product mix, and declines in several low-margin products that were replaced with more profitable product sales. We expect gross margins to be stable in 2026 at the levels we were able to sustain in 2025. Turning to operating expenses, R&D expenses for 2025 were $11.7 million compared to $12.1 million in 2024, largely driven by lower employee-related costs and lower stock-based compensation expenses. R&D expenses for the year ended 12/31/2025 were $52.3 million compared to $46.3 million for the prior year. The year-over-year increase was primarily due to higher employee-related costs, higher lab supplies expense, and the internal reclassification of certain employees to the research and development function, partially offset by a decrease in outside services related to manufacturing and regulatory expense. Selling, general and administrative expenses were $11.2 million for 2025 compared to $13.0 million in the prior year period. The decline was largely due to lower employee-related costs and reduced use of outside services. SG&A expenses for the year ended 12/31/2025 were $47.1 million compared to $55.1 million for the prior year. The decrease was primarily due to lower stock-based compensation expenses, lower legal expenses, and reduced use of outside services. The fourth quarter 2025 expenses also include a one-time restructuring charge of $3.4 million related to the reorganization announced in November 2025. Throughout 2025, we sought ways to reduce our operating costs and improve gross margins. The improvements I just mentioned were prior to the benefits realized from the reorganization. We anticipate our operating expenses will also show improvement in 2026. We intend to use these savings to partially fund the planned increase in capital expenditures associated with our GMP facility build-out. For 2026, the combination of operating expenses and capex should be similar to what we experienced in 2025. Net income for 2025 was $9.6 million compared to a loss of $10.4 million for 2024. Net loss for the year ended 12/31/2025 was $44.0 million compared to $65.3 million for the prior year. We expect 2026 revenue to be in the range of $72 million to $76 million. For the first quarter, we are comfortable with the current consensus estimates. Similar to quarterly trends we saw last year, we expect the 2026 revenue to be more heavily weighted towards the second half of 2026 versus the first half. Codexis, Inc. ended 2025 with $78.2 million in cash, cash equivalents, and short-term investments, which we expect will be sufficient to fund our planned operations and capital expenditures through 2027. With that, I will now turn the call back over to Alison.

Thank you, Georgia, and thank you, Britton. ECOsynthesis is a disruptive technology that can radically alter the landscape of oligonucleotide manufacturing. As with any potentially disruptive technology, the first step is to show that it can actually work. In 2025, we achieved that. The next step is to show that the technology is useful to our customers. We believe we also demonstrated that in 2025 by having success in multiple feasibility studies with our customers. The next step is to support the deployment of our technology into our customer pipeline. We intend to make significant progress in this regard with several customers in 2026. We also want to show the value of our approach in longer-term contracts with higher dollar values committed to each one. This is a lofty goal, but one we are determined to achieve this year. Our goals for 2026 are simple. Show our investors proof of success. We can do this by signing the types of contracts I mentioned above and also new innovative licensing deals. We will also be focused on financial performance, meeting our revenue targets while being mindful of our expenses, which is everyone's responsibility within Codexis, Inc. We want to continue to innovate in the field of RNA medicine using our skills and experience in biocatalytic enzymes. We will be presenting at the TIDES meeting this year and will showcase our work on stereoisomer control. This important new development has the potential to be our next product offering. We will also communicate our ongoing progress in scaling up our ECOsynthesis manufacturing platform and making progress toward achieving half-kilogram scale by the end of this year. Later this year, we will plan to begin the retrofit construction of our GMP facility, which is an important strategic asset for the company, and we will keep you updated on our progress there as well. 2026 is shaping up to be the year when ECOsynthesis is not just an alternative production technology, but the technology of choice for our customers’ RNA medicine. We are excited by our prospects and the dedication and achievements of our employees who have been instrumental in making the ECOsynthesis technology a reality. Now we will be happy to take your questions. Operator?

Thank you. Our first question is from Allison Bratzel with Piper Sandler. Please proceed.

Hey, thanks guys and thanks for taking the question. I know of late you have been highlighting the potential value for stereoisomer control and the potential to yield a superior drug profile. Could you just talk to when might we see that validated either preclinically or clinically? And are any of your existing 55 opportunities actively exploring this? Thank you.

Thanks so much for the question. We are working very hard on this this year because we think that the opportunity may be very important. We are already examining the biological activity of some of the stereo configurations that we can generate using the ECOsynthesis platform. We are going to show more substantive data around those stereo configurations at the TIDES U.S. meeting. And over the whole course of this year, we will be doing further work to associate those stereo configurations with the possibility of improved potency. This is based on a published precedent. In addition, we have had several conversations with customers who have pipelines that include siRNA assets, and they are also interested to collaborate with us to elucidate the opportunity for their particular assets. So we have a lot of activity in this area for 2026, and we expect beyond.

Our next question is from Kristen Kluska with Cantor Fitzgerald. Please proceed.

Hi, this is Richard Miller on for Kristen. Just a quick question. Could you help us kind of understand the general process of how you got to the recently announced deal? Thank you.

Are you referring to the deal in the recent press release?

Yes, that is correct.

I think I will ask Britton to speak about the history of that relationship and how we think about that deal and the potential for the future progress in that relationship.

Yeah, Alison, thanks. This deal in particular is very, very exciting. This is, as we mentioned in the press release, a small organization that has a cardiovascular asset that are looking and understand that what they are trying to achieve, the current industry cannot meet their needs. And so from very early on in their development of this asset, they have been in discussions with us because they know they have a challenge and they need to figure out a way to address that challenge and be able to bring their product to market. So these discussions have been going on for many, many months with this organization, and they are very, very excited working with us. We are very excited working with them because we both believe that the ECOsynthesis manufacturing platform can meet their needs and deliver the materials that they need for their clinical asset that eventually will get into commercial production as they work their way through the different clinical trials they need to go through.

Our next question is from Matthew Hewitt with Craig-Hallum Capital Group. Please proceed.

Afternoon and congratulations on your progress. Maybe just to dig in a little bit more on the 50-gram contract. Could you walk us through, so this initial agreement is for low 7 figures. Walk us through the process. So this is preclinical work. What happens next? Assuming the data comes back positive, where do they go to, what, you know, what phase do they move into? What does that contract look like? I am assuming it is much larger than 50 grams. So help us extrapolate what this could ultimately become as this moves from a preclinical study into maybe, at some point, a commercial product.

Yeah. I will start with that, Matt. Thank you. So we like this prototype, and we hope that we would fill our book of business with a pipeline of these. So the example is that we commit to feasibility studies. We have been talking about that over the last year, where we determine if our technology and the particular sequence and construct that a company is interested in progressing, if there is a good match. We have seen that across numerous molecules now and are really starting to build a database and also build credibility across our current customers about the capability and power of the platform. So this contract that you are referencing was also initiated as a feasibility study, so a service-type contract. And as we continue sharing data with this particular client in this contract, we will be completing this component of this contract with the delivery of 50 grams of material that this customer will then use to do preclinical studies with, and they will start to create their early-stage comparability assessment of our product. Beyond this preclinical work, one would expect that if the data continues to look successful, that the company will be interested in progressing product generated using the ECOsynthesis platform into an IND submission, and they would be generating toxicology material and GMP material suitable to start a clinical trial. If our production platform continues to be their designated manufacturing process, then our aspiration is that we will become their manufacturing partner and provide ultimately commercial material to them, assuming that their asset proceeds through development.

That is helpful. Is there a way for us to—and I am not asking for specific numbers—but how do we think about as that scales through development from, you know, preclinical to tox studies and beyond, how do we think about that low seven figures? Does that become mid seven figures? Does it become multiples of that? I am just trying to figure out what can this become if you and your partner are successful with this specific program.

Well, I think, one way to think about it, I am going to—you know, this is just an example that we wanted to share. And like I said, what our aspiration is to build a portfolio of such customers. And I also referenced that we have been doing feasibility that we think has been incredibly valuable with multiple customers over the last, you know, 15 months or more. And we have provided those services in a way that has been very easy for those customers to try to use the ECOsynthesis technologies to test them out. But we are moving forward with a powerful technology that is more and more recognized, and we absolutely would expect that licensing deals associated with technology, the opportunity to commit to this technology, would be much more significant in terms of the kind of revenue that they would earn for Codexis, Inc. In addition, as you know, after our GMP facility is operational, we will be selling product. In addition, we think that some of these things will go hand in hand. Some customers may want to license the technology completely and bring the technology in-house, in which case we will supply enzymes. Smaller companies may want to purchase GMP siRNA from Codexis, Inc. direct, and we will be able to do all of those. Certainly, if our technology delivers a superior asset and we can prove that, then again, we would expect that that could generate increased value for Codexis, Inc. and our shareholders.

Got it. And if I could sneak one more in, and this one might be a little more geared towards Georgia. But what type of visibility do you have into the $72 million to $76 million revenue guidance that you have this year? I guess, how much of that do you feel like you have got line of sight or contracts in hand versus how much of that is still something that you expect to receive over the remainder of the year? Thank you.

I mean, it is a good question. And, you know, we are sitting in the early part of 2026. So the way that we build our projections is to look at historical buying practices of our clients and make assumptions moving forward. As you said, at the beginning of the year, you always have a certain amount of your projections that are speculative, that are unknown, and this year is not any different. But the base of our business is from what we look forward to from our past buying practices of our customers. So we do have line of sight on quite a large percentage of this business, but, you know, it is still early in the year.

Got it. Thank you very much.

Our next question is from Dan Arias with Stifel. Please proceed.

Yes, hi guys. Thanks for the questions. Alison, maybe a high-level one here. You guys are entering a new phase with what you can do. So I guess I am just curious where you think the industry finished 2025 when it comes to total siRNA demand? I mean, I remember when you first talked about this pivot towards ECOsynthesis back in 2023, I believe. You had a slide that said that it was like a thousand kilos a year and that by the next decade, it could be 30,000 kilos. So I know these big picture questions are sort of tough to answer, but for those that are kind of trying to keep tabs on this scale-up journey, where does it feel like we are at the industry level right now?

Yeah. That is a great question. I think that the siRNA therapeutic pipelines seem very vibrant at the moment. Of course, we can look right at the end of that, we can look at commercial assets. There are several commercial assets now, so that total number is growing. You can see that the commercial asset revenue line is growing. We also know that there are a couple of very large indication-size siRNA assets sitting in some large pharma pipelines. And then, through those types of customers and our interactions with them, we also understand that there is an extremely large number of siRNA assets in preclinical and early-stage clinical trials. So I myself look at the clinical trial numbers on fda.gov, and I count them sometimes, and those are growing very nicely. To your point about demand, you are correct that the estimates on demand, you know, they vary significantly, but we are, I think, confidently looking at something like—I will give you a broad range—10 to 30 tons, 10 to 30 metric tons of oligonucleotide material required by 2030. So I think that there is a very significant addressable market there, and we intend to have a significant piece of that.

Yep. Okay. Very helpful. And maybe just a follow-up. Georgia, how much gross margin variability do you see when you think about that mix of outsourced business versus partners that are taking ECO in-house directly over, say, the next 12 to 24 months? Is that something that represents a mix question, and so therefore a profitability question? Or do you not see it that way?

No. We do not really see it that way. The ECO business right now has been primarily services, so there is not a lot of gross margin you can calculate off of ECO, that side of our business right now. So the gross margin is really calculated on product sales only, and so that right now, the majority of that is our historical biocatalysis business. And the gross margins are pretty stable there. We were able to sustain a 64% gross margin for the entire year. I mean, there was some quarterly variability, but we got 64% gross margin in the fourth quarter plus for the whole year. So we feel pretty good about having that margin, or close to it, with some margin of error around that through 2026. We see that as being pretty stable now.

Okay. Thank you.

Our next question is from Brendan Smith with TD Cowen. Please proceed.

Great. Thanks for taking the questions, guys. I wanted to actually ask about the revenue mix from here and maybe just gut check a few modeling assumptions. I understand your color around the legacy biocatalysis business. But is it fair to assume at least kind of incremental or modest growth of that segment over the next two years? Or should we interpret kind of this broader strategic pivot to mean ultimately winding down in biocatalysis revenues as some of these newer partnerships take more and more share of revenue growth? Just kind of checking in on how we should think about the split of your growth over the next few years. Thanks.

Yeah. Please, Georgia.

The bulk of our growth is—we really do expect that to come from the ECO side of the business. Our base business, the small-molecule biocatalysis business, has stabilized, and we do—we mentioned that we had a pipeline of products that are in late-stage clinical testing. We have had data readouts on three of those. Two were successful. We do expect that that side of that pipeline of opportunities will continue to fuel growth for the next few years. But it is more—the higher growth rate we expect to come from the ECO side of the business. I hope that answers your question.

Sure. Yep. Sounds good. Thank you.

There are no further questions at this time. I would like to turn the conference back over to management for closing remarks.

Thank you so much, everybody. I hope you can tell we are so excited about what is ahead and really appreciate you joining for our call today. Thank you.

Thank you. This will conclude today’s conference. You may disconnect at this time and thank you for your participation.