John Nicols
Analyst · Jefferies. Your line is open
Thanks, Jody. Good afternoon everyone and thank you for joining us. As Jody mentioned, we have posted a brief slide presentation on the Investors section of our Web site to accompany today’s call and I encourage you to follow along. I’m exceptionally proud of Codexis’ performance during 2018 as we executed on a wide array of strategic objectives and achieved or exceeded all of our financial guidance metrics for the fifth consecutive year. Let me turn your attention to Slide 3. We’re pleased to report that 2018 revenues reached nearly $61 million, an increase of 21% over 2017. R&D revenues led the way, as expected, up 50% year-over-year. Per guidance, product revenues delivered a similar result in 2018 cementing in the prior year’s huge gains. And importantly, we continued to expand product gross margins again exceeding guidance and topping 50% for the year. In Performance Enzymes, revenues grew a solid 7% into our traditional pharmaceutical manufacturing sector making up just under 60% of sales. But revenue progress into the other sectors took off in 2018. Performance Enzymes sales into non-pharma sectors grew by 39% and our sales in Novel Biotherapeutics segment grew by 76% year-over-year. This result rapid growth in new sectors on top of solid core pharma manufacturing growth is the core result we have been engineering here at Codexis. So it’s a true pleasure to highlight for 2018. In addition to those financial accomplishments in 2018, we delivered on many strategic fronts as well. So let’s review some of the highlights by segment, starting with Performance Enzymes. Here our proudest accomplishment was the commercialization of enzymes that enabled the proprietary process for Tate & Lyle’s most recently launched sweetener, a better tasting zero calorie stevia sweetener Tasteva M. Codexis started R&D on those enzymes engineering proof of concept and patentability on our own in late 2016. Then we struck our Tate & Lyle’s partnering deal in the first quarter of 2017 and this enabled the funded enzyme R&D to kick into high gear. By the end of 2017, our enzymes from CodeEvolver were orders of magnitude more effective. And then in 2018, the partnership shifted to each party’s concerted scale up commercialization and GRAS registration efforts. Commercialization was accomplished in the third quarter of 2018 and Tasteva M was out on the market, from concept to commercial in less than two years. We are excited to learn from Tate & Lyle that their initial customer interest has been strong and that some niche products are already using Tasteva M commercially. We expect over time that enzyme sales for Tasteva M will become one of the largest products in our Performance Enzymes portfolio. Beyond food, the launch of enzymes for molecular diagnostic markets led the way for us to penetrate other non-pharma verticals in 2018. Our first enzyme, a DNA ligase was launched in 2018, trialed by dozens of target customers and at the AMP conference in San Antonio in November, we had one of those target customers present their trial results which validated our claims of superiority in next-gen sequencing or NGS workflows. As we close 2018, we generated our first sales and find multiple leading NGS players seeking to gain preferred access to our EVO T4 DNA ligase and convince us to partner with them versus going to market on our own. In parallel at AMP, we showcased superior technical results for our DNA polymerase in late-stage R&D which garnered additional wide market interest. DNA polymerase is the largest enzyme class used in the fast growing nine digit molecular diagnostic market worldwide. With these two enzyme successes in 2018, we are hitting the mark to materially penetrate this growth market in 2019 and beyond. In pharma manufacturing Performance Enzymes, we continued to build this core business in multiple strategic ways in parallel in 2018. Eight pharma companies contributed greater than $1 million each in sales in 2018, a significant widening of material pharma market adoption versus last year. One of those, a top 10 global pharma company, had never purchased significant amounts from us in any year prior. Porton Pharma Solutions was also one of these two eight pharma customers in 2018, as we completed the transfer of high throughput protein catalyst screening capabilities to them in the fourth quarter. We are proud to go from deal to $1 million plus revenues in less than a year and to have finally partnered our catalytic enzymes into the extensive opportunity pipeline of a leading pharma contract manufacturer’s operations. The partnership is off to a solid start. With yet another of our top eight pharma clients, KYORIN of Japan, we now add to our list of fully commercialized protein catalyst installations. Last month, we announced a multiyear supply agreement with KYORIN for a Codexis developed proprietary enzyme used in the manufacture of vibegron, an active ingredient in Beova for the treatment of overactive bladder. Beova was approved and commercially launched by KYORIN in Japan in the second half of 2018. We have also supplied the same enzyme to Urovant Sciences for their manufacture of vibegron. Urovant holds the marketing rights to vibegron in the rest of the world outside Japan. Urovant has indicated they expect to announce top line Phase 3 results from vibegron in the first half of this year. Rounding out the pharma manufacturing strategic accomplishments, we are pleased to have recently entered into a multiyear technology upgrade package with Merck which as you know licensed our CodeEvolver protein engineering technology platform in 2015. We are delighted with Merck’s decision to capitalize on the productivity enhancements we have made over the last few years with our CodeEvolver technology. Valued at low single digit million dollars, this is the first material backend revenue created by Codexis from its CodeEvolver licensing business model. Merck continues to set the standard for deploying protein engineering for pharma manufacturing. Merck’s list of uses start with their consumption of our largest protein catalyst product in a growing percentage of their commercial drug substance manufacturing for their flagship product JANUVIA plus their procurement of multiple parallel dedicated project teams at Codexis throughout 2018, plus having an installed CodeEvolver license they operate in-house and now procuring multiyear upgrades for this platform. We continue to believe that most of the world’s largest drug companies have comparable applicability span for benefitting from our protein engineering technology and we continuously work to bring other pharma companies towards the Merck high bar. Switching to the Novel Biotherapeutics segment, our success advancing our orally administrable enzyme therapy candidate CDX-6114 for phenylketonuria or PKU was the most remarkable step-out performance for Codexis in 2018. Here we successfully ran the company’s first-ever clinical trial, a Phase 1a study in healthy volunteers which showcased the drug’s safety and tolerability plus a resultant dose dependent pharmacodynamic response. In addition, we opened an investigational new drug or IND filed with the USFDA and completed a solid dose formulation assessment that earned Codexis a $1 million milestone from Nestlé Health Science in the fourth quarter. We are highly gratified by Nestlé’s decision earlier this month to exercise their option to exclusively license CDX-6114, which triggered a $3 million milestone payment. Nestlé Health Science has now assumed essentially all of the forward clinical development and commercialization activities for this enzyme. To-date, we have earned $21 million under the CDX-6114 collaboration. From here, we have the potential to earn additional pre-commercial milestone payments up to a total of $86 million plus up to $250 million if CDX-6114 goes commercial. We are also entitled to tiered royalties on commercial sales of CDX-6114 ranging from mid-single digit percentages to low-double digit percentages. In addition and importantly, the clinical and partnering success of CDX-6114 provides substantial credibility for our Novel Biotherapeutics strategy to discover a pipeline of differentiated drug candidates using our CodeEvolver platform and credibly developing those towards and into early clinical development. We currently have five additional enzyme therapy candidates in our Novel Biotherapeutics pipeline beyond PKU, to target inborn errors of amino acid metabolism disorders, to target lysosomal storage disorders and the fifth program is a funded partnership with Nestlé Health Science. During 2018, we increased the staffing for this pipeline, brought in specialized drug discovery talents and secured increased funding from Nestlé for that discovery partnership, all of which has enabled us to accelerate advancement of the pipeline significantly. We are encouraged and excited about these programs in the Novel Biotherapeutics business we have credibly developed in 2018. Throughout 2018, we also strengthened core resources to ensure our forward momentum continues. Financially, our clean debt free balance sheet ended with over $50 million in cash bolstered by a successful modest equity raise in the second quarter. We’ve retained and added to our human talent in parallel. Protein engineering R&D team capacity has grown smartly to keep up with demand, new industry veterans have been brought in to strengthen core growth areas in biotherapeutics research, molecular diagnostics and industrial enzymes. And adding to that, I’m exceptionally pleased to welcome Laurie Heilmann who recently joined Codexis as Senior Vice President of Business Development and Marketing. Laurie brings us more than 30 years of industry experience with a proven track record of transformative strategies resulting in increased revenue growth, profitability and global brand awareness. I’m delighted with our outstanding business accomplishments. I’m proud of the great Codexis team and their dedication to our success. It’s highly gratifying to announce that for the second consecutive year, the National Association of Business Resources has named Codexis as one of the Best and Brightest Companies to Work For in both the San Francisco Bay area and in the nation as a whole. Our outstanding team has been decorated with an award that Gordon and I see every day, a diverse, hardworking, super smart group of people who collaborate creatively to make Codexis the great company that we are. Let me now turn the call over to Gordon to provide more details on our financial results. Gordon?