John Nicols
Analyst · Jefferies. Your line is now open
Thanks Bruce. Good afternoon everyone, and thank you for joining us. I’m proud of our outstanding financial and operating performance with year-over-year revenue growth of 31% for the second quarter, and 51% for the first half of 2018. Our growth has been driven by sharply higher R&D revenues, with significant contributions from collaborators, Nestlé Health Science and Tate & Lyle. Our R&D revenue streams are becoming an increasingly sustainable part of our business, as our customers recognize the value of the CodeEvolver protein engineering platform and they establish dedicated project teams at our Redwood City facility to more rapidly advance their programs. For example, I'm pleased to report that we recently added a second dedicated project team for Nestlé Health Science to accelerate the development of the novel bio therapeutic program, we initiated when we struck our platform partnering deal with them in the fourth quarter of last year. Combined with teams for Merck, Tate & Lyle and another major Pharma company we had -- we had 10 funded dedicated project teams working here at Codexis at various times during the second quarter. Sales to the pharmaceutical industry continued to provide the majority of our 11 plus million dollars of performance enzymes segment sales for the quarter. We get significant business with two new customers during the quarter one, a major U.S. pharmaceutical company, and the other a leading Japanese Pharma company, reinforcing success against our goal of lightning our adoption across a larger set of customers and Pharma manufacturing processes. Our new -- partnership with Porton designed to extend our pharma reach even further, was announced in the quarter and the joint teams have gotten off to a solid start in establishing new workflows and customer engagements in our first few months. Other efforts to drive growth in Performance Enzymes continued to advance nicely as well. For the molecular diagnostics industry, we have staffed up our internal team to three industry veterans now and we are lining up for the promotion of our DNA ligase and one other new high-Performing Enzyme at the advanced molecular pathology or AMP Conference in early November. We remain very confident in the development of this business as we finished 2018 and move into 2019. Excellent progress in those industries, but the major highlights for our Performance Enzymes segment comes from the food industry, where we are proud to announce the commercialization of new Performance Enzymes from our second partnership with Tate & Lyle. Here the Codexis team engineered a suite of enzymes that enables Tate & Lyle's novel bio conversion route for manufacture of their new zero-calorie, TASTEVA M, Stevia Sweetener. Tate & Lyle describes its newest food ingredient as a Reb M Stevia Sweetener that starts from the Stevia leaf offering a clean sugar like paste and consumer friendly labeling. TASTEVA M is expected to eliminate the bitter taste that is held back the widespread adoption of historical Stevia sweeteners into food and beverage applications. Reb M has been known in the industry as a better tasting type of Stevia for some time, but it's limited availability in the Stevia leaf and its high cost to manufacture have been major challenges. Here’s where Codexis came in. Codexis conceived a new process to make Reb M back in late 2016, one that could potentially break through cost barriers, and one that could enable a clean pathway to patentability in a crowded, intellectual property landscape. The problem back then was no enzyme could be found anywhere in nature, in our libraries or from competition that could make even a minuscule yield of the contemplated process for Reb M from Stevia leaf extract. Less than two years later, Codexis teams created, patented and commercialized the needed suite of enzymes, several of which required over 100 amino acid sequence modifications, that now enabled the low cost route for industry leading partner Tate & Lyle's TASTEVA M commercial launch. Others have been working on alternative routes to Reb M for nearly a decade, and most have yet to commercialize. During the second quarter, we completed all pilot scale registration batches for the TASTEVA M enzymes, earning us significant R&D milestones. In July, we received verbal commitment from the Generally Recognized as Safe, or GRAS, expert panel that our enzymes can be self-affirmed as GRAS. Great accomplishment by the teams at Codexis and Tate & Lyle and a model for both of us on how to best forge an industrial technology partnership. We look forward to sharing updates on our enzymes sales to TASTEVA M going forward, encourage that it will develop into one of the largest products in our Performance Enzyme portfolio in the future. Shifting gears to provide key update in our novel biotherapeutic segment we are similarly pleased to share positive progress for our recently initiated Phase 1a trial with the oral enzyme therapeutic candidate CDX-6114, for patients with phenylketonuria, or PKU disease. This first in-human trial with CDX-6114 is evaluating the product safety in four cohorts of healthy volunteers receiving increasing dose levels of CDX-6114. Initiation of this phase 1a trial has triggered a $4 million milestone from Nestlé for Codexis that we expect to receive in the third quarter. In a few weeks since beginning this trial, dosing of the first three cohorts has already been completed successfully and we are now moving onto the fourth and final dosing level. We are on track to report topline results from this Phase 1a trial in the fourth quarter of this year. Recall that the topline results can provide efficacy indications by biomarker measurements in healthy volunteers as well as a safety evaluation. Following the topline report we expect that Nestlé Health Sciences’ decision whether to exercise their option to take over the forward development of CDX 6114 will be known by early 2019. Our efforts to advance other novel biotherapeutics and our pipeline are also encouraging. To that end, I’m delighted to welcome Dr. Hicham Alaoui, in the newly created position of Vice President, Biotherapeutics Research & Development. Dr. Alaoui brings valuable drug discovery skills and expertise in house into Codexis. The creation of this new position demonstrates the company’s continued conviction to rapidly build out our biotherapeutics discovery and development capabilities and to follow our success in bringing CDX 6114 into early clinical trials. Hicham is directly responsible for advancing our biotherapeutics discovery pipeline and accelerating drug candidates towards the initiation of clinical trials. Before turning over the call to Gordon, I’d like to review our updated Codexis 2018 pipeline snapshot posted today to our website, which provides a favorable report card on our substantial progress over the past year ending June 30, 2018. As you can see on slide two, we’ve added 10 projects to the pipeline during the past year and on slide four you can see that we have added 17 over the past two years, that’s a 65% increase in two years time. Our strategy is to expand our pipeline across multiple industries and applications in parallel, and at this more detailed level, we are showing excellent pipeline momentum as well. For example, we have doubled the number of late clinical phase 2 or three projects over the last two years to now stand at 14 Codexis Performance Enzyme installations. Similarly, the number of Performance Enzyme projects in other industries has increased to eight and equally important now covers three different industrial verticals. The total number of Performance Enzymes that have commercialized increase from 8 to 9 in the past year and noting that TASTEVA M discussion increased by another one in July. Finally, the number of projects that could access the self funding has grown from four two years ago to 11 currently. Led by the growth in our novel biotherapeutics pipeline investments, these programs have the prospect for generally larger economic rewards to Codexis than funded projects. Increasing pipeline numbers, with increasing diversity, advancing to commercialized sustained revenues, that summarizes our 2018 pipeline snapshot. I'm proud to unveil all of this impressive growth and progress in our pipeline, which I attribute entirely to the dedication and talents of the Codexis team. Let me turn the call over to Gordon to discuss the financial results now. Gordon?