CDXS

Greetings, welcome to the Codexis Report 2026 Q1 earnings call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press *0 on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Georgia Erbez, Chief Financial Officer and Chief Business Officer. Please go ahead.

Thank you, operator. With me today are Dr. Alison Moore, Codexis' President and Chief Executive Officer, and Britton Jimenez, Senior Vice President, Sales and Marketing. During this call, management will be making 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 and successful execution of current and future programs and partnerships. To the extent that the statements contained in this call are not descriptions of historical facts regarding Codexis, they are forward-looking statements reflecting the beliefs and expectations of management as of the statement date, May 7, 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' control and that could materially affect actual results. Additional information about factors that could materially affect actual results can be found in Codexis' filings With the Securities and Exchange Commission. Codexis expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Now I'll turn the call over to Alison.

Thank you, Georgia, and thanks, everyone, for joining. While it's been a short 8 weeks since our last call, we've accomplished a lot at Codexis. We are pleased to report another strong quarter and are busy preparing for the TIDES conference next week, where we will present important new data on our ECO Synthesis technology. Codexis generates manufacturing solutions using biocatalytic enzymes. Over the last 3 years, we have developed the ECO Synthesis manufacturing platform for the production of RNA medicine, specifically siRNA, and we are now focused on bringing this to the market. The standard approach of using solid-phase oligonucleotide synthesis for siRNA manufacturing is complex, solvent-intensive, and challenging to scale. Currently, siRNA pipelines are expanding from rare diseases to large population indications, which will create a significant manufacturing bottleneck in the next 3 years.

ECO Synthesis has the potential to alleviate production constraints by delivering greater scalability and higher product quality with the added benefit of dramatically improving environmental impact. Last year, we achieved a number of important milestones in platform performance and industry engagement, which generated tangible interest from our customers. In 2026, the potential impact of our platform is well understood, and across the industry, we are seeing increased interest in enzymatic production solutions. Our goal is to position Codexis as the leading manufacturing technology innovator. We are operationalizing our platform through scaling, improving process control, and by our platform's unique capability of delivering superior siRNA product. A new feature of our ECO Synthesis platform is the ability to generate siRNA with specific stereochemical control. Stereoisomers exist at both ends of most siRNA molecules and are made of the same atoms but are arranged differently in three-dimensional space.

As a reminder, drug developers have little influence over stereochemistry today, as existing chemical manufacturing methods produce random mixtures that can vary in terms of therapeutic potency and purity. Our engineered enzymes used in ECO Synthesis can deliver product with specific stereoisomer configurations. These stereopure molecules confer overall improved product quality and have the potential to deliver improved potency. We continue to explore the biological impact of this control and believe it could be a tremendous asset to those customers who seek ways to improve their products. Our small molecule biocatalysis business remains an important part of Codexis and provides support for the investments we are making in ECO Synthesis. We supply uniquely designed enzymes for 13 branded commercial pharmaceutical products. This portfolio continues to grow with the recent approval of islatravir, a part of an important new combination treatment for HIV.

Codexis partnered with Merck, who carried out groundbreaking process chemistry, substituting a 16-step chemical synthesis with a biocatalytic cascade. This achieved a Green Chemistry Challenge Award in 2025. We are supplying enzymes for this commercial product and are proud to participate in this supply chain for HIV patients. We are making remarkable progress at Codexis, and momentum is increasing in 2026. We are proud of the advances we are making to further enhance the utility of the ECO Synthesis platform. We look forward to showing our customers and investors additional tangible proof of value of the technology. Now, to update you on our commercial activities and progress, let me turn it over to Britton.

Thanks, Alison. Our ECO Synthesis manufacturing platform continues to mature into a thriving and successful business. Most importantly, it is a platform capable of broadly supporting product development for the most important growing modality in the genomic medicine space. The number of RNA medicines in development is growing at an estimated rate of at least 10% per year, with over 100 candidates in clinical trials and more than 400 in pre-clinical development. Current production technologies will not be able to keep up with future demand. For example, there are 4 drugs in late-stage clinical development for cardiovascular indications. A 2%-3% market penetration of one of these therapeutics into a 25 million addressable patient population will require more oligonucleotide production than the entire rare disease portfolio combined.

The impact of these powerful new therapies may not reach their full potential if they cannot be produced reliably, efficiently, and at scale. As innovators and CDMOs search for ways to expand capacity, the importance of new production technologies is rapidly accelerating, and this market is currently estimated to be at $2 billion. For our ECO Synthesis platform, we have over 50 opportunities in our sales pipeline with 40 individual companies demonstrating strong continued interest in our technology. The evaluation work with our CDMO partners is progressing and long-term commercial discussions are also moving forward. The industry knows there needs to be a change. We intend to be the best option for both drug innovators and CDMOs. In connection with what Alison mentioned before, our customers are interested in exploring how stereoisomer control can be incorporated into their products.

We believe this new capability can improve product purity and potency for therapeutics. We are excited to add this approach to our ECO Synthesis portfolio. In advance of the TIDES USA meeting, we completed exciting new data on stereochemistry. This groundbreaking presentation will underscore the breadth of our leadership in enzymatic technology. During TIDES, we will host a roundtable discussion with industry experts focused on stereochemistry and the value it can bring to next-generation RNA medicines. We will have additional presentations on environmental sustainability and the performance of highly engineered ligases. Turning to our small molecule biocatalysis business, it remains stable and profitable. We continue to support 13 commercially approved products that are dependent on our enzymes. As we mentioned on a previous update call, we have a number of projects in clinical development.

In the last 6 months, we have had data readouts on 3 studies, 2 of which were positive and 1 of which received FDA approval last month. We are assisting our customers with preparation for commercial launch for both programs. Our pipeline remains robust with 11 programs still in phase III clinical development and data readouts expected on 4 clinical trials in the next 12 months. We are excited for our prospects in 2026 and beyond. The next 3 years represent a critical window to increase global oligonucleotide production capacity. The industry must confront the challenge of scaling from manufacturing less than 1 metric ton of oligonucleotide therapeutics annually to 10-50 times that in the next decade. There isn't a more important time for enzymatic production approaches to be deployed in global production infrastructure, and we are driving the ECO Synthesis platform toward this opportunity.

With that, I will now turn the call over to Georgia for a discussion of our financial results for the first quarter.

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-Q file today for a more detailed discussion. Total revenues were $15.2 million for the first quarter of 2026, compared to $7.5 million in the first quarter of 2025. The increase was primarily due to revenue from the Merck Technology Transfer Agreement executed in the fourth quarter of 2025, which has now been fully recognized. Product gross margin was 71% for the first quarter of 2026, which compares to 55% for the first quarter of 2025. For the first quarter of 2026, the increase was primarily driven by product mix and sales declines in several low margin products that were replaced with more profitable product sales.

We continue to expect 2026 annual gross margins to be comparable to the annual levels we reported in 2025. Research and development expenses for the first quarter of 2026 were $11.4 million, compared to $12.9 million in the first quarter of 2025, largely driven by lower allocable costs that were partially offset by higher employee-related costs and higher use of outside services. Selling general and administrative expenses were $9.8 million in the first quarter of 2026, compared to $12.4 million in the prior year period. The decrease was primarily due to lower employee-related costs due to lower headcount, lower stock-based compensation expenses, and lower consultant fees and outside services.

Net loss for the first quarter of 2026 was $8.7 million, compared to the loss of $20.7 million for the first quarter of 2025. We are fully engaged in our project to retrofit our new GMP plant and located in Hayward, California, that was leased in 2025. We are currently in the detailed design phase and are preparing to apply for a building permit in the second quarter. Construction is planned to get underway in the second half of the year and we expect to be fully operational by the end of 2027. Together with our Redwood City headquarters, this marks a continued step forward in how we support development, scale-up, and manufacturing our customers products. We reiterate our revenue guidance and expect 2026 revenue in the range of $72 million-$76 million.

Like the quarterly trends we saw last year, we expect 2026 revenue to be more heavily weighted towards the second half of 2026 versus the first half. Codexis ended the first quarter with $65.1 million in cash equivalents and short-term investments, which compares to $78.2 million at the end of 2025. We expect our current cash will be sufficient to fund our planned operations and capital expenditures through the end of 2027. As a reminder, our financial guidance and cash runway include the expenses associated with the build out of our GMP facility. With that, I will now turn the call back over to Alison.

Thank you, Georgia, thank you Britton. Our proprietary ECO Synthesis platform technology has the potential to radically alter the landscape of oligonucleotide manufacturing. The next step for Codexis is to deploy the technology into our customers pipelines. We are working hard to achieve this goal in 2026. For investors, we want to show proof of success. We can do this by signing broader and higher value types of contracts as well as innovative licensing deals. We will also be focused on financial performance by meeting our revenue targets while being mindful of our expenses. We will continue to innovate in the field of RNA medicines using our skills and experience in biocatalytic enzymes. Our presentations at the TIDES USA meeting next week in Boston will showcase our newest innovation.

We are continuing to scale up our ECO Synthesis manufacturing platform, and we are making progress towards achieving half kilogram scale by the end of this year. I believe 2026 could be the year when ECO Synthesis is no longer viewed as just an alternative production technology, but the technology of choice for our customers' RNA medicines. We are excited by our prospects and proud of the dedication and achievements of our employees who have been instrumental in making the ECO Synthesis technology a reality. Now, we'd be happy to take your questions. Operator?

Thank you. We will now conduct a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, that's star one to ask a question at this time. One moment while we poll for the first question. The first question comes from Allison Bratzel with Piper Sandler. Please proceed.

Hi there. This is Peter Spanou Panagianopoulos, on for Allison, and thank you for taking the question. I was wondering if you can give us a preview of what to expect from the upcoming stereochemistry data that will be presented at TIDES. As a follow-up, I'm wondering when we can expect to see some data demonstrating that this stereo control translates to improved efficacy. Thank you.

Thanks for the question, Peter. Yeah, we're very excited to show our data next week. What we are going to show for the first time demonstrates stereo control at both the three prime and the five prime end of the siRNA molecule. This has not been shown before, and we will show data describing how we achieve that and the product quality of the product. We are currently working on generating data associated with the potential for improved activity. We have some data already, and shortly we are going to have more. I would also point out that there is some extremely nice published literature that has already demonstrated the opportunity of stereo control in siRNA medicine, and that stereo control confers improved stability related to intracellular nuclease activity.

Even mechanistically, there's a hypothesis about why there ought to be the opportunity of improved potency. As I said, we have those data in the works and we will definitely be sharing those when we have them also. Thank you.

The next question comes from Kristen Kluska with Cantor Fitzgerald. Please proceed.

Hi, this is Ayen on the line for Kristen. Thank you for taking our question. Could you speak at a high level about the risks that are involved in scaling the platform from a 100 gram scale to, like, 500 gram by year-end? Now that you're operating at 100 gram, what aspects of the scale-up process do you believe have been de-risked versus what remains to be proven? Thank you.

Thank you for the question. We have a very skilled and experienced process development team here at Codexis that we have built over the last 3 years that have expertise both in traditional oligonucleotide synthesis, some of whom are enzymologists and some of whom are what I would call more classic process development individuals. Together, they're working really well on stepping through the scale changes, which are often 5 to 10X scale changes every time we scale the process. I think you may be aware we started with a very lab scale process, and now we're at a scale where we can certainly deliver material for preclinical development and very shortly approaching the ability to deliver kilo scale.

I mentioned that our goal is to achieve 0.5 kilo scale by the end of the year. Twofold from there will be much more straightforward. The kinds of challenges that we're meeting during scale-up are what I would call normal process development challenges. Those are often the challenges of control, of temperature, flow rates, et cetera, as we start to use larger and larger equipment. We're learning a lot about how to scale the process. I think that is part of the secret sauce that manufacturing technology companies start to accumulate. We continue to deliver products of higher and higher quality, actually. That's what matters at the end of the day. I hope I answered your question.

Yes, you did. Thank you for that color.

The next question comes from Matt Hewitt with Craig-Hallum. Please proceed.

Good afternoon, congratulations on the strong start to the year. Maybe first up, regarding the Merck enzyme, I'm just curious. Historically, those have been talked or discussed as being kinda $5 million-$10 million in annual revenues. I'm just curious where this one kind of fits into that and how we should be thinking about the ramp of that specific product this year.

It is a brand-new approval for us, and we are very excited by this, and we are working with Merck right now as we, you know, work through their demand for the product moving forward. We'll hope to have more information for you in future calls. Right now we're working with them on their supply chain and their demand on manufacturing moving forward. Stay tuned, and we'll hopefully have some more information for you in future calls.

Got it. Then maybe separately, the ongoing engagement that you have with the FDA regarding the ECO Synthesis platform, maybe an update on how those conversations are progressing and what will be the ultimate outcome from those discussions? Does it allow for faster approval with potential partnerships down the line? Or just explain what this will ultimately lead to. Thank you.

Yeah, thanks, Matt. That's a great question. We're actually right now working on a briefing bit for our next interaction with the agency, which we are planning for in approximately a quarter. Codexis was accepted into the Emerging Technologies Program in 2024, and we have been engaged with the agency around the ECO Synthesis manufacturing platform in various conversations since then. The upcoming conversation that we will be having is an ongoing part of that program. In addition to the Emerging Technologies Program, we are working to put together the foundational information that is required to make a submission towards an Advanced Manufacturing Technologies designation. It's called a AMT designation.

If and when we achieve that Designation, that does enable faster timing on review times and the potential for accelerated approval.

That's great. Thank you.

The next question comes from Matt Stanton with Jefferies. Please proceed.

Hey, thanks. Maybe one on the CDMO partnership side. Sounds like the goal is to commence another strategic partnership by the end of 2026, which is good to see. Would love to just get an update on the three existing CDMO partnerships you have now that it's been a few quarters. Any proof points, learnings, next steps? How do you think about, you know, some of those original partnerships, you know, being able to engage more meaningfully towards, you know, contracts, revenue, things like that over time? Thank you.

Yeah, absolutely. The partnerships we have with the CDMOs that we've announced are going fantastic. The engagement with the different CDMOs around our technology, them getting a better understanding of our technology, how it works, how it scales, like I said, have just been fantastic. Everyone's been extremely pleased with the results of that. Because of the great work of the teams on both here, within Codexis and within those partnerships, that has allowed for us to advance our commercial discussions. We're in progress of those discussions. Everything's looking very, very positively. We're looking forward to, you know, what lies ahead of us as we do believe there's a great path in front of us. As for other potential CDMO partners, absolutely.

We're always evaluating the marketplace as we want to ensure that the availability of our technology is out there for our customers, the drug innovators, to be able to get access to the technology. You know, it's an exciting time. These partners are critical to our strategy. It opens the doors and allows for bigger and better opportunities for us because it's another pathway for us. You know, great things going there.

Great. Maybe just on the broader pipeline. You know, it sounds like a lot of progress. You talked about a licensing deal with a major pharma company, hopefully in the back half of 2026 here. Just any more flavor you can provide. Is that kind of 1 that you're working on you think hits? Do you have 2 kind of opportunities and you're assuming 1 of them comes through? Would love just a little more color on that. Anything you can provide in terms of the scope or shape of what that could look like. Is it early-stage work? You know, is there any chance they could be looking at, you know, running it in parallel on clinical pipeline programs? Just any more flavor in terms of the pipeline there and what that could look like over time.

Thank you.

Yeah. There's definitely a lot of conversations happening around that. There's multiple opportunities that sit in front of us with, you know, bigger and broader partnerships. You know, those discussions have very different flavors to them because each of those organizations are looking at our technology in different ways. You know, I'd say the discussions are ongoing. They're looking positive. I can't get into a lot of details around this right now, just because of the types of conversations we're having. No, we're very optimistic about this. You know, the excitement around this technology and the data that we're presenting, you know, further enhances the value, you know, out there in the marketplace. I'd say, great conversations, still more to come here in the future.

Super. Thank you.

The next question comes from Brendan Smith with Cowen and Company.

Hey, yeah, I just wanted to ask in terms of the sales funnel, obviously, a lot of breadth here, but could you give a little more color on breakdown of out of those 40 companies, what's the mix between like large pharma, larger biotech and emerging biotech? Then maybe in terms of the 55 programs, could you just speak to which are maybe further along than others relative to each other?

Yeah, no problem. Regarding the organizations, the funnel is very, very healthy. Why I say that is our conversations cover across that entire spectrum that you mentioned. You know, we're talking to some of the largest drug innovators in the RNAi space. We're talking down to, you know, some stealth companies. The size and shape is very different, which is fantastic because it gives us diversification within the platform, the technologies. There's, you know, we're de-risking the conversations. We're not in one just specific market segment, which is great. Now, of course, in those conversations, like I mentioned, you know, those organizations have different ideas on how they want to engage with us using our ECO Synthesis's platform. Each of those conversations are unique and a little different on what we're trying to accomplish.

In regards to the programs, again, there is no one size fits all. There, you know, people are talking to us about, you know, everything from very early stage assets to clinical assets to commercial assets and everything in between. You know, I can't sit here and say we only talk about one thing because there is a very good diversification within our conversations, which is really exciting.

I guess a large part of the thesis obviously has been the broader demand outstripping existing supply. Maybe with this technical differentiation, are you viewing even some smaller indications and maybe more niche programs as potential opportunities from a asset differentiation standpoint? Are there any other ways that you view are technically feasible beyond just this upcoming TIDES presentation, which we're looking forward to? Thanks for the questions.

As Britton just stated, at the moment, just to be clear, we have existing work and existing contracts with some very large pharmaceutical companies and with innovator and stealth companies for the ECO Synthesis manufacturing platform. We are very open to what folks might like to use the platform for at the moment. Since we're really just starting to show the data and show real evidence of the product quality associated with the opportunity of stereo control, I expect that we probably will get some more inbound interest there, and we certainly will be interested to work with a variety of customers there.

We don't have unlimited bandwidth and, actually, just right at the moment, we are working on improving productivity and throughput so that we can make sure that we have the right kind of velocity to and capacity to meet those customers' demands. I suppose maybe, Brendan, your question is, at the end of the day, if there would be a high volume client, or a client with high volume potential, we would prioritize that client.

Thanks.

Thank you. At this time, I would like to turn it back to Alison Moore for closing remarks.

Thank you everyone for joining us today, and we will certainly be looking forward to seeing some of you at upcoming investor conferences. If at any time you have additional questions, please feel free to contact us. I hope you have a good afternoon and evening. Thank you.

Thank you. This does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation, and have a great day.