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Codexis, Inc.
2/28/2024
Welcome to the Codex's fourth quarter and full year 2023 earnings conference call. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note that this call is being recorded. And now I'll turn the call over to Carrie McKim, Director of Investor Relations. Please go ahead.
Thank you, operator. With me today are Dr. Stephen Dilley, Codex's President and Chief Executive Officer, Kevin Norris, Chief Operating Officer, Sri Riali, Chief Financial Officer, and Stefan Lipp, SVP of Research. 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 2024 revenue, product revenues, and growth margin on product revenues, as well as our strategies and prospects for revenue growth 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, February 28, 2024. 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 Codexus Filings with the Securities and Exchange Commission. Codexus 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 Stephen.
Thank you, Carrie, and thanks everyone for joining. Seven months ago, we took decisive action to reduce our cash burn by more than 50% and execute on a clear, prioritized strategy. We ended 2023 strongly with clear indications that the strategic decisions we made last year are translating into real momentum. This was illustrated by the series of exciting and validating announcements we made in December, specifically the achievement of gram-scale synthesis with our Ecosynthesis Manufacturing Platform, the completion of an exclusive licensing agreement with Aldebaran for our Codex HiCap RNA polymerase, and our purchase agreement with Nestle for CDX 7108. We've continued that upward trajectory with a couple of positive updates already under our belt in 2024. First, driven by the extremely encouraging technical progress we're making with the Ecosynthesis Manufacturing Platform that Stefan Lutz will describe later in his call, we announced plans to initiate the construction schedule for our Ecosynthesis Innovation Lab, We expect that this facility will be a hugely valuable resource to support the technical and commercial advancement of our ecosystem manufacturing platform. Additionally, the Innovation Lab is intended to enable us to provide sufficient GLP-grade siRNA directly to innovators to support preclinical development of their product candidates. As Kevin will describe, this gives us access to a critical part of the growing siRNA ecosystem. Furthermore, we anticipate that the learnings from the Ecosynthesis Lab will enable us to move to in-house, full-scale GMP siRNA production when the time is right. Now, while the business case for acceleration of the Ecosynthesis Innovation Lab is compelling, we made sure to secure the financial resources first by executing on a very carefully designed strategic debt financing with Innovatus Capital Partners. Sri will describe the financial details in his comments, but the punchline is that the Innovata's deal fully funds the construction and operation of our Ecosynthesis Innovation Lab several years and strengthens our balance sheet and increases our operational flexibility for our projected runway to cash flow positivity around the end of 2026. On the heels of that announcement, we were also delighted to welcome two additional members to our strategic advisory our strategic direction. Finally, we added more strength to our balance sheet just over the last few days when we announced the completion of an exclusive out-license for a non-core asset, this time with Roche for a newly engineered double-stranded DNA ligase. As you can see, we've done exactly what we said we were going to do, and even more, right on the timelines we laid out. As a result, We now have projected runway through positive cash flow expected around the end of 2026, an innovation engine with an anticipated billion-dollar-plus market potential in our ecosystem's manufacturing platform, and an adjacent growing core pharmaceutical manufacturing business that generates cash and boosts our relevant commercial reach. Before I pass it off to Stefan and then Kevin to review our recent technical and commercial progress, let me share some thoughts on how we view the road ahead. Moving to slide three. Our path to success starts with our longstanding pharmaceutical manufacturing business. We've been working hard to return this core business to an upward trajectory, and today we're pleased to highlight anticipated 2024 product revenue growth of at least 10% from 2023. Underpinned by our co-devolver-directed evolution platform, the value of the technical expertise, credibility, and commercial relationships we developed through this business Furthermore, the cash our pharmaceutical manufacturing business generates is an invaluable element of supporting our runway to breakeven and positive cash flow. That said, we believe our eco-synthesis manufacturing platform to enable the commercial scale manufacture of RNA therapeutics has true breakout potential to transform the value trajectory of Cadexis. The great thing about Cadexis is the synergy of the experience commercial infrastructure, our pharmaceutical manufacturing business, with the emerging opportunity of the Ecosynthesis Manufacturing Platform. A beautiful example of that synergy is how we're approaching the commercialization of our double-stranded RNA ligase program, which is an important stepping stone on the way to fully enzymatic siRNA synthesis. To recap, the RNA ligase is designed to allow innovators to build full-length siRNA from several shorter fragments. That's important because both the cost and impurity profile of phosphoramide chemistry-built molecules increases with the length of the construct. It's a nice idea, but in order to turn it into a real commercial opportunity, you have to be able to build an enzyme optimized for the specific reaction being driven and rapidly scale the manufacturing and supply to fit in with the requirements and schedule of the customers. We believe Cadexis is uniquely equipped to meet that challenge because we've been doing something extremely similar for a decade or more through our pharmaceutical manufacturing business. Look for some exciting news flow on our EcoRNA ligase program in the second quarter. And now I'd like to pass the call over to Stefan Lutz, Senior Vice President of Research, to describe some of our exciting progress on the Ecosim manufacturing platform. Stefan.
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