3/11/2026

speaker
Operator
Conference Operator

Greetings. Welcome to Codexys Report's 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. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the call over to Georgia Urbeth, Chief Financial Officer and Chief Business Officer. Please go ahead.

speaker
Georgia Urbeth
Chief Financial Officer and Chief Business Officer

Thank you, Operator. With me today are Dr. Allison Moore, Codex's 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 Codexys, they 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 Codexys' control and that could materially affect actual results. Additional information about factors that could materially affect actual results can be found in the Codexes filings with the Securities and Exchange Commission. Codexes expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. And now, I'll turn the call over to Alison.

speaker
Dr. Allison Moore
President and CEO

Thank you, Georgia, and thanks, everyone, for joining. At Codexys, 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's not a medicine if you can't 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 as a key technology provider in this market. Let's talk about how we're 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. We are 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 platform 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 three 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 platform, 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 the first quarter of 2026, and since then we have passed a facility and quality management system inspection by a large pharmaceutical customer, Redying Codexis, for ecoenzyme 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-US, 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 products. 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 farmers 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, Nido Avicii, and Axolabs, highlighting the motivation from major providers who clearly understand the current limitation of standard solid fizz 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 shoot 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 expenditures and made the hard decision to realign our workforce 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 the end of 2027. It's 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've made in 2025 to achieve liftoff of the EcoSynthesis platform. and 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 Brittain.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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