John Nicols
Analyst · Craig-Hallum Capital Group. Please proceed
Thanks, Jody. Good afternoon, everyone, and thank you for joining us. We are very pleased to report another quarter of exceptional execution. We delivered strong sequential growth with revenues of $18.4 million and solid progress across all growth verticals. Product revenue for the quarter, again, exceeded our pre COVID expectations. In Q3, sales to 3 customers topped the $1 million mark with Merck's Januvia active ingredient, sitagliptin, continuing as the leader. Allergan, another top 20 global pharma company, was the next leading contributor, followed by Urovant Sciences for vibegron, its product candidate for overactive bladder. Sales of vibegron to Urovant and pharma have been very strong so far this year, and we expect another strong quarter from Urovant in Q4. The FDA's determination on Urovant NDA for vibegron is rapidly approaching with an assigned PDUFA date of December 26, and a positive outcome bodes well for future sales of this product for Codexis. Additional momentum during the quarter came from another top 20 pharma customer, who needed a significant batch of our enzymes to make their drug substance for Phase 3 trials. As anticipated, our larger volume manufacturing partners have remained consistently operational to date with minimal impact from the pandemic. This is allowing for the continued production of critical materials from them. Our supply chain team continues to successfully manage the logistics on schedule. Given our strong execution to date and our outlook for the fourth quarter, we expect full year product revenue to be nicely above our pre-COVID-19 guidance range and very close to what we delivered in 2019. A favorable mix in product sales led to another quarter of strong product gross margin. At 57% in 3Q and 56% year-to-date, 2020 is tracking well above historical product gross margin averages. In the fourth quarter, we expect more than half of our product sales will be for the manufacturer of Merck's Januvia active ingredient, which will likely bring 4Q product margins down sequentially. Nonetheless, we expect 2020 product gross margin to be at or near the high end of our pre-COVID-19 gross margin outlook range of 43% to 47%. All around, 2020 has shaped up as an excellent year for our product sales. R&D revenue for the quarter was also strong at $8.5 million. We recorded revenues greater than $1 million each from Nestlé Health Science, Takeda, Novartis and Merck. Importantly, our lab is now running at nearly 100% of pre-pandemic levels with safety measures in place to protect our scientists. With our R&D operations and nearly full capacity, we expect the effect of COVID-19 on revenue to be minimal in the fourth quarter and future quarters. We will remain agile in the event the pandemic changes our circumstances, which, of course, remains a possibility. Let me now share details on the significant progress we are making across each of our growth verticals, starting first with our Novel Biotherapeutics segment. First, we are pleased to report on clinical progress and the path forward for CDX-6114 for Feno or PKU. Here, Nestlé Health Sciences recently completed a safety, tolerability and PK/PD Study of CDX-6114 for the first time in PKU patients. Consistent with past clinical results, CDX-6114 was, again, well tolerated and safe at all doses tested. In addition, an increase in acid levels, a biomarker of enzyme activity, was observed, which is consistent with the intended mode of action for CDX-6114. Based on the results of the study, Nestlé Health Science has decided to undertake additional solid dose formulation development prior to initiating its next clinical trial, which will be a multiple ascending dose Phase 1b study. Accordingly, results from the Phase 1b study are now expected to read out in 2022. We are also collaborating with Nestlé Health Science on 3 other disease targeted programs. The lead program CDX-7108 for an undisclosed gastrointestinal disorder is making solid progress towards its first clinical trial, which is expected to commence by the middle of 2021. GMP batches of CDX-7108 have been manufactured by our CMO Partner, and preclinical toxicology studies have been completed with audited reports expected to be ready around year-end. The other 2 programs are in earlier discovery stages and are also progressing well. One of these discovery projects was just added significantly increasing the funded R&D revenue we are generating from the Nestlé Health Science discovery partnership for the foreseeable future. Each of these 3 assets are co-owned between Nestlé Health Science and Codexis. It's exciting to see the list grow and the programs advancing. Once again, our new gene therapy partnership with Takeda led to strong results for the quarter. We continue to execute well against all 3 of the different disease targets we are pursuing together, allowing us to generate significant revenues in Q3. The Fabry Program is the most advanced in our Takeda partnership. Here, the joint team is undergoing final stages of in-vitro and in-vivo characterization of Codexis-generated transgenes with improved stability and activity against the target substrate. Accordingly, the Fabry joint team - sorry, the joint Fabry team is well positioned to make a recommendation by the beginning of next year concerning which transgene will progress for packaging into Takeda's viral vector. The Pompe program continues to favorably progress as well albeit from a less advanced starting point than Fabry when we initiated the Takeda deal. We have submitted an abstract and expect to present transgene improvement data from our Pompe program for the first time at the World Symposia in February of next year. In food and other industrial applications, we also had a good quarter. We are starting to see enzyme sales for Tate & Miles, better-tasting Stevia sweetener, TASTEVA M, generate meaningful revenue. We generated a few hundred thousand dollars in sales for those enzymes in the third quarter stepping up the slope nicely on a sequential basis. We also generated 6-digit food sales in another food application in the quarter and generated early development stage sales for 3 additional projects in other industrial verticals. Switching to life sciences. We continue to see good progress in that arena, moving all 5 of our disclosed enzyme programs forward in the quarter. We are advancing nicely in the installation of our improved DNA ligase with Roche. Despite COVID, the technology transfer has proceeded well during 2020 and is now tracking according to expectations, following a pause of 1 to 2 months at the start of the outbreak. Tech transfer was completed in October, triggering the first milestone payment under the licensing agreement. The 3 new enzyme products targeting the life science space in collaboration with have all progressed well during the quarter and support our expectations for strong growth in this segment in 2021 and beyond. Our high fidelity DNA polymerase is undergoing final formulation following extensive beta testing with select partners, we expect to record first commercial product sales around the end of the year. Our T7 RNA polymerase is undergoing extensive evaluation of commercial-ready material with multiple partners and the feedback is good. It is unlikely that we will achieve installation into first wave vaccine manufacturing processes due to the speed of implementation required and the significant safety-related change control procedures that make it hard for manufacturers to switch away from incumbent processing aids. However, we remain confident based on the feedback received to date that the enzyme is sufficiently differentiated to achieve penetration into mRNA vaccine manufacturing processes during the course of 2021. We are entering early stage testing of our improved reverse transcript days enzyme, having successfully manufactured trial batches of an early variant. It's still early days for the program, but the engineered enzyme is performing well in initial trials, and we expect customer feedback in the fourth quarter, which will guide our ongoing optimization of the product, ahead of a planned launch in the beginning of 2021. As I described last quarter, our partnership with molecular assemblies is focused on a disruptive enzyme-based approach to synthesizing DNA, with 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. We have required radical improvements to make enzymatic DNA synthesis competitive with traditional chemical synthesis that underpins the $1 billion-plus synthetic DNA market today. The program has started well, and the teams are collaborating to drive the initial concept proving improvements to validate the approach. We are very encouraged by early progress, and we continue to expect completion of the enzyme improvement program in the second half of 2021, enabling early commercialization efforts to begin soon thereafter. I'd like to thank the Codexis' team for the outstanding job in bringing us back on to our growth - strong growth trajectory as we close out 2020. With that, let me turn the call over to Ross for a review of our financial performance. Ross?