John Nicols
Analyst · Jefferies. Please proceed with your question
Thank you, Stephanie. Good afternoon everyone. I'm very pleased to present a strong first quarter 2021 results for Codexis. With the company's growth drivers continuing to accelerate, we began the year with even stronger momentum than we anticipated. Total revenue grew by 23%, compared to a year ago and with a growing list of commercializing enzymes, product revenue grew by 101% year-over-year. With our sales mix continuing to shift toward higher-margin products, we also delivered impressive product gross margins of 59%, up from 50% a year ago. Our focus on high-growth opportunities is bearing fruit. This quarter, we had 15 customers, who contributed over $100,000 in revenue and we had five customers, who contributed over $1 million in revenue. In our sustainable manufacturing segment, on top of a strong base of product sales to Merck for Januvia manufacturing and to Allergan and Urovant for their commercial products, we have an exciting list of late-stage clinical development installations, driving product revenue growth in 2021. In the Life Science Tools market, we're off to a strong start with expanding adoption for our own broadly marketed RNA and DNA polymerases, coupled with a strong quarter for R&D revenues for customer-partnered programs, including several that were initiated in the first quarter. And finally, in our Biotherapeutics segment, we steadily advanced our pipeline assets in the quarter and completed key IND-enabling activities that set up our second drug candidate to enter clinical trials later this year. Ross will provide more details on the first quarter results and guidance shortly. But first, I'll provide detailed updates across each of the businesses. Starting with our Performance Enzymes reporting segment, we are growing the business and focusing on two distinct markets. The first being sustainable manufacturing. This is where we built Codexis' enzyme engineering leadership over the past two decades and this market represents the large majority of the company's revenues currently. Codexis' novel high-performance enzymes enable our customers to dramatically reduce the cost and increase the sustainability of manufacturing their end products. Compared to using traditional non-enzymatic chemistry, which is capital-intensive and inefficient, our engineered enzymes decrease capital needs meaningfully, while also enabling higher yields, reduced energy usage and lower wage generation. And our CodeEvolver platform is constantly accelerating the speed of our ability to discover and design these value-creating enzymes. Small molecule pharmaceutical processes have been and continue to be a core target for growing the sustainable manufacturing market for Codexis. We have partnered with 21 of the 25 largest pharmaceutical companies in the world, to help them adopt and install novel Codexis enzymes for manufacturing their APIs. Merck is a great example of the work we do with our pharma partners. One of the original projects that we tackled with Merck was to improve the cost and efficiency of manufacturing the active ingredient sitagliptin in their blockbuster diabetes drug Januvia. The enzyme we engineered for the sustainable manufacturing of sitagliptin was one of Codexis' earliest commercialized products and continues to be a significant revenue generator for us today. As a result of our work with Merck on sitagliptin and other projects, Merck recognized the value and wide applicability of using enzymes in their processes and decided to license our CodeEvolver platform to accelerate their adoption by performing enzyme engineering on their own in-house. More recently, another significant project we collaborated on with Merck was the design of novel enzymes to sustainably manufacture islatravir, their investigational drug for HIV. We help them convert a 16-step traditional chemistry process to one that only requires three steps, dramatically improving their capital efficiency and yield. The proprietary process utilizes nine enzymes, a groundbreaking enzyme cascade process installation, only made possible by the extensive use of our CodeEvolver enzyme engineering platform. We supplied over $1 million of several of these enzymes to Merck in the first quarter. In general, our newer sustainable manufacturing enzymes like these for islatravir are being priced at above-average gross margins. These newer more profitable products are making up an increasing portion of our product revenue. Our sustainable manufacturing pipeline also has an increasing number of pharma products in late-stage clinical development, with the potential for FDA marketing approval approaching. Recently and excitingly, we've been helping two different large pharmaceutical companies by developing novel enzymes for manufacturing their COVID-19 antiviral clinical stage candidates. With accelerated development pathways for COVID treatments, these candidates are moving through the clinic much more rapidly than other pharmaceutical products. Two proprietary Codexis' enzymes are key to the manufacturing processes of these two clinical stage products and hold exciting prospects as potential new sources of product revenues for Codexis. In addition to pharma, in the past few years we've been expanding to other industries; designing enzymes for sustainably manufacturing a range of applications, including food and beverage ingredients, recycling, consumer care and animal feed. These products have relatively short development time lines and lower regulatory hurdles, enabling our enzymes to reach the market more quickly. In the first quarter we announced the commercial installation of new higher-yielding enzymes for each of TASTEVA M Stevia and DOLCIA PRIMA Allulose, two of Tate & Lyle's most exciting new sweetener product launches. These cost-reducing enzymes enable our partner to further accelerate their already promising customer adoption outlooks. In addition with a deep and growing pipeline of other late-stage development industrial enzyme candidates, we expect this shift towards higher margin and faster-to-market products will continue to accelerate Codexis' growth. Another relatively new area of expansion for Codexis is the life science tools market, which is a significant growth opportunity for the company. Codexis' Performance Enzymes can enable improvements in next-generation sequencing and liquid biopsy genomics, diagnostics, biosensor applications and more. This market is highly attractive, given its high growth, rapid commercialization cycles and above-average margin prospects. This market also affords us the opportunity to develop products that can be marketed to multiple customers, in addition to the highly customized enzymes we engineer for specific partners. We've recently developed three new Life Science Tools enzymes for broad-based customer marketing: Codex HiCap RNA polymerase, Codex HiFi DNA polymerase and Codex reverse transcriptase. Our RNA and DNA polymerases have led the way, as we rapidly advance these enzymes toward commercialization last year and began marketing at the end of 2020. In the first quarter we're already demonstrating success. We engineered Codex HiCap RNA polymerase to provide dramatically higher capping efficiency, enabling customers to significantly reduce the amount of cap agent that is required in the manufacturing recipe alongside an RNA polymerase. The graph on the right side of this slide shows the improved capping efficiency from using Codex HiCap at various cap agent loading levels. In addition, our proprietary enzyme decreases the production of unwanted double-stranded RNA, which increases the product -- the customer's product yield and simplifies downstream purification needs. In the first quarter, we recorded our first commercial sales of Codex HiCap RNA polymerase to several customers, who tested and validated it to yield and efficiency benefits. The product is also in various stages of customer trials with several other messenger RNA manufacturers. This excellent start to customer adoption gives us confidence that we're well positioned for potential installation in a range of processes for development stage mRNA-based vaccines and therapeutic candidates. We expect product sales to continue to grow through the rest of this year, setting up for a meaningful sales pace as we finish 2021 and beyond. We're also making great progress with the launch of Codex HiFi DNA polymerase. It has been formulated in a master mix that is a standard formulation used for library amplification and next-generation sequencing. Our analysis demonstrates that Codex HiFi DNA polymerase enables the highest next-gen sequencing fidelity results of all the competitive DNA polymerases we tested. We showcased our findings at the AGBT conference this quarter, which drove increased customer interest. The enzyme is currently in trials with dozens of customers for potential use in their current and future NGS kits. In addition to these broadly marketed products, we are also growing customer partnered Life Science Tools programs. Continuing the recent trend in Q1, we added multiple new customer-funded Life Science Tools R&D programs with undisclosed partners to our pipeline. Several significant projects kicked off in the first quarter, which helped drive R&D revenue from this type of work up over 45% year-over-year to well over $1 million in Q1. With the surge in demand for R&D project teams for these new customer-funded projects, we temporarily shifted some resources away from the finalization of the engineering of our reverse transcriptase enzyme, slightly delaying its commercialization. We are now expecting that product to launch in the second half of the year. One extremely exciting customer partner project we're working on in the Life Science Tools market is our groundbreaking collaboration with Molecular Assemblies for the commercialization of enzymatic DNA synthesis. This disruptive approach to synthesizing DNA has the potential to significantly impact a wide range of high-value markets from drug discovery and manufacturing through synthetic biology and longer term to compete with silicon for data storage. Leveraging the power of CodeEvolver, we are engineering enzymes with the dramatic performance improvements that should make Molecular Assemblies process a commercially viable, cost-effective and differentiated solution to manufacture a long-chain DNA. We remain on track to complete the enzyme engineering work for this program in the second half of 2021, enabling Molecular Assemblies to begin early commercialization efforts soon thereafter. With an increasing number of differentiated products and strong partnerships in the Life Science Tools market Codexis continues to build momentum to capitalize on this high-growth opportunity. In closing out the business review, we see tremendous growth potential for Codexis in the discovery and development of Novel Biotherapeutics. Here we are rapidly building and advancing a high-value pipeline of oral biologics and gene therapy candidates discovered using our CodeEvolver platform. Just a few years ago we had only two very early-stage programs in our pipeline. Fast forward to today and we have a dozen programs in the pipeline including one in clinical stage and another in IND-enabling development. We have an impressive multi-program partnership with Takeda Pharmaceuticals focused on improving gene therapy candidates for rare diseases. We are leveraging CodeEvolver to engineer transgenes with improved attributes such as enhanced expression, improved half-life greater stability better uptake in difficult-to-access cells et cetera. At the WORLDSymposium in February, we presented some exciting new transgene optimization data, we've developed for Pompe disease one of our programs partnered with Takeda. We screened over 19,000 variants of alpha-glucosidase and engineered a GAA variant with dramatically enhanced attributes that overcome the key limitations of existing Pompe disease therapies, improving stability in enzyme half-life, increasing time-dependent uptake into challenging cellular targets and eliminating predictive epitopes to reduce immunogenicity. We're proud of the success we have generated in gene therapies after just one year in collaboration with Takeda. Modifying transgenes using CodeEvolver to enable a gene therapy's expression of better performing enzymes is a novel and differentiated approach to design improved next-generation gene therapy candidates. Accordingly, we have embarked on self-funded discovery programs targeting improved transgenes for other rare disorders. Leveraging CodeEvolver to discover novel oral biologics that are more safe stable and efficacious for GI indications is another high-value growth strategy for Codexis. We have four oral biologics in partnership with Nestlé Health Science and three early stage self-funded programs. Three of the partnered programs with Nestlé are co-owned between the parties. And the most advanced of those CDX-7108 is poised to begin its first clinical trials later this year. Most of our IND-enabling activities for CDX-7108 are complete including preclinical toxicology studies and GMP manufacturing campaign setting the stage for IND submission in the third quarter of this year. Let me now hand the call over to Ross to take you through our financial results in more detail.