Dr. Stephen Dilly
Analyst · Jefferies. Please proceed with your question
Thank you, Brendan and thanks to everyone for joining. Since our second quarter earnings call, we've been working to refine Codexis strategy by assessing the markets where Codexis and our proprietary CodeEvolver platform have a clear competitive advantage. This review of Codexis ongoing programs enable us to make intentional choices about where we are best equipped to drive long-term success and increase market penetration and ultimately where we should focus our resources. Although this is an ongoing process, we have the building blocks of a refreshed vision for the company. I look forward to providing an initial high level view of this strategy during today's call and anticipate drilling further into the details in the first quarter of 2023. We've recently made several, exciting appointments to our leadership. Kevin Norrett, who is with us on today's call recently joined Codexis as Chief Operating Officer. We're also delighted to welcome Meg Fitzgerald as our new Chief Legal Officer and General Counsel, with Rahul Singhvi, rounding out the recent additions as a new member of our Board of Directors. Each of these individuals brings valuable expertise to our team and will prove critical to executing on our vision. Right now, we're very focused on prioritizing the most attractive market opportunities for our business segments and heightening our commercial discipline across the company. Our enzyme engineering platform has many potential uses and Codexis has undertaken many exploratory projects rooted in interesting science in both our Performance Enzymes and Biotherapeutics business segments. In fact, we increased our R&D investment significantly during the last two years. We initiated many of these efforts when capital was easier to access and relatively inexpensive. Now today's market reality is significantly different. So we need to react accordingly a narrower focus. We've learned a great deal from each program in our pipeline and we're able to apply those insights to make informed decisions about how and where we choose to invest moving forward. And whether we make these investments on our own or in partnership with others. Kevin will share additional insight on where we see opportunities for Codexis to focus in the near-term. One of our critical guiding factors is to ensure we maintain cash runway through the end of 2024, providing us with time and flexibility to leverage the extensive scientific capabilities and intellectual property that we have at Codexis. Our comments today will focus on the opportunities in which we see the strongest potential for near-term economic success. Specifically, when discussing our Performance Enzymes segment, we will focus on our pharmaceutical manufacturing and Life Science businesses, which represent roughly 95% of the revenue that we generate in this segment today. Within the Life Sciences market as with the rest of our business, we aim to identify and invest in programs to drive deeper value from a more concentrated set of assets. Similarly, in our Biotherapeutics business, we will highlight which of our assets based on analysis of the market opportunity and competitive environment we view is having the greatest potential to create significant value within the next few years. We at Codexis know how to create and build a profitable business. Even when we exclude profit contribution from PAXLOVID, we project our pharmaceutical manufacturing business when looked on as a standalone entity will generate a very healthy operating margin in 2022. Furthermore, we can continue to grow pharmaceutical manufacturing with modest investment. As a reminder, today we are selling enzyme to biocatalysts, to pharma manufacturers for 14 therapeutic drugs that are currently approved for commercial sales. Another 20 drug candidates currently in Phase II and Phase III clinical trials use our enzymes in their chemistry manufacturing control process. This pipeline, the potential approvals reinforces our confidence in our ability to continue to grow this sector over time. Although, this is a healthy and growing business we have work to do, many of the larger companies have already developed or will soon develop their own biocatalytic capability. To continue to compete effectively, we must increase our commercial efforts to reach new customers and work tirelessly to improve our responsiveness and value add proposition. Shifting now to our Life Science business, we believe this is an area with significant growth potential for Codexis in 2023 and beyond. We believe our CodeEvolver technology can make important contributions across a broad range of Life Sciences applications. Inevitably, this means we need to carefully choose where to invest ourselves and where to leverage others. Specifically, we view genomic sequencing and DNA and RNA synthesis as attractive markets in which Codexis technology and products can deliver strong competitive advantage. To date, this has been publicly demonstrated by our licensing to Roche of an improved DNA ligase for NGS library prep, which continues to progress towards commercialization in new kids, as well as our development what we believe to be a best-in-class terminal transferase enzyme for enzymatic DNA synthesis in collaboration with Molecular Assemblies. We will continue to leverage our core strengths of developing unique engineered enzymes or indeed suites thereof that either enable or improve our genomics customers product offerings or our biopharma customers manufacturing processes. Our goal is to focus on identifying opportunities for Codexis to act as a long-term partner, ultimately providing end-to-end solutions for customer needs as opposed to being limited to our standalone enzyme product offerings. We also remain optimistic about the value that our innovative partners Molecular Assemblies of Sequel bring to the equation and we're confident they will play a key role in our path to success in the Life Sciences arena. Now raving out the performance enzymes segment, there are clearly applications for our technology in other areas such as food, nutrition and industrial enzymes. However, these end-markets represent a very small component of our current revenue and there is considerable if need both in terms of investment and expertise to turn this into a profitable business. Given the market reality I outlined earlier, we'll be very thoughtful about how we spend resources here moving forward. Shifting to our Biotherapeutics business. Our most advanced asset is CDX-7108, a drug candidate for the treatment of exocrine pancreatic insufficiency or EPI. This assay is being co-developed with our partners at Nestle Health Science. EPI occurs when a patient cannot produce sufficient pancreatic enzymes specifically lipase to digest fat, protease to digest protein and amylase to digest sugars and leads to weight-loss, metabolic disturbances in fat malabsorption. EPI is currently treated with preparations of porcine derived pancreatic enzymes that are enteric coated to survive the acidity of stomach. Although, the existing therapies are reasonably effective at delivering amylase and protease activity, achieving adequate levels of lipase activity is challenging and patients often experiencing, continuing symptoms of fat malabsorption. Despite their current limitations, the two leading therapeutics on the market today have combined annual sales of roughly $1.5 billion. CDX-7108 is a potent lipase that has been specifically engineered to remain highly stable in stomach acid that overcome the limitations of existing therapies by delivering improved lipase activity with a less burdensome dosing schedule. Our partners at Nestle Health Science are currently dosing our first patient in a Phase Ib multi-dose trial having successfully completed the volunteer portion of the study. We anticipate that in the first quarter of 2023 we'll have sufficient data to support moving forward with a Phase II clinical trial and assuming positive data we'd expect to start the Phase II trial in late 2023. CDX-7108 is an attractive first entry into the biotherapeutic space. We're using our technology to improve upon a proven approach in a multi-billion dollar existing market with a partner that is already achieved commercial success. Our second clinical stage asset CDX-6114 fully out-license Nestle Health Science is an oral enzyme candidate to treat patients with phenylketonuria, one of the most common inborn areas of metabolism or [IEMs]. Nestle Health Science is currently optimizing the formulation of CDX-6114 to improve performance and we expect them to initiate a Phase I clinical trial in 2023. If this collaboration can successfully demonstrate benefit in PKU patients with CDX-6114, this will inform our decisions around the oral enzyme approach to other IEMs. Switching now to gene therapy. While our CodeEvolver technology undoubtedly has many potential applications in gene therapy, we are very well aware that this is a complex and competitive arena. Specifically, we can use CodeEvolver to engineer proteins that may improve targeting an expression within the body when administered as transgenes in gene therapies offering potentially improved therapeutic benefit as compared to the current options for treatment for conditions like Fabry disease, Pompe disease and Hemophilia A. On this front, we have a fruitful partnership with Takeda. As with our collaborations with Nestle, our partnership with Takeda is structured to help us learn, derisk, cover cost and ultimately leverage the power of our transgene engineering capabilities to introduce new therapeutic options for rare diseases and in markets where the unmet need remains high. We are hopeful that one of our transgene therapy assets for gene therapy partnered with Takeda should enter Phase I clinical trials in late 2023 or 2024 and we look forward to providing further updates. In summary, as a relatively small company, we have an abundance of opportunities to build value both on our own and in carefully chosen partnerships, but we need to be disciplined about how much we can successfully take on given our finite resources. Now I'd like to turn the call over to Kevin to discuss in greater detail our go forward commercial strategy.