John Nicols
Analyst · Jefferies. Your line is now open
Thanks, Bruce. Good afternoon, everyone, and thank you for joining us. The second quarter was another very solid performance for Codexis, as we continued to deliver against the critical objectives we established for 2019. Expanding our customer base, commercializing installations in pharma manufacturing, adding to and strengthening our CodeEvolver platform licensing network, breaking out in molecular diagnostics and other new industrial verticals, advancing our Novel Biotherapeutics pipeline, bolstering the cash on our debt free balance sheet and on-boarding critical new human talent, all of these were delivered in this very productive second quarter. Let me now walk you through some details to highlight our progress, starting with product sales. Product sales were up 68% year-over-year and led the way for us in the second quarter. As usual, enzyme sales to Merck for their manufacturing of the active ingredient in Januvia were a solid seven-digit baseload for our product sales. Excitingly, in addition, we have generated over $1 million of product sales with another top 25 pharmaceutical customer in the quarter as they began the manufacture of registration batches for their planned 2020 drug launch, following its recent New Drug Application or NDA acceptance by the FDA. In total, eight customers purchased over $100,000 of products in the quarter, up from five customers in the second quarter last year, reinforcing the accelerating penetration of our Performance Enzymes in real world manufacturing processes. Urovant Sciences was among the leaders for our product sales, as they lined up supplies for their planned NDA filing with the FDA in early 2020 for vibegron a potential treatment for overactive bladder. Rounding out the list of clients with more than $100,000 in product sales, were two more top 25 pharma customers each meeting batches of Performance Enzymes for their clinical stage drugs, two leading generic pharmaceutical companies and Tate & Lyle for the manufacturer of their better tasting a TASTEVA M Stevia sweeteners. Product gross margins in the quarter came in at a very strong 56%, which lifted first half product margins to 50%. R&D revenues for the quarter were predictably down year-over-year due to large comps in the prior year quarter from Tate & Lyle and Nestle Health Science. But excluding these two events, R&D revenues were up in excess of 40% year-over-year, and these were spread over a larger customer and industrial base. Six-digit plus R&D revenues were generated in the quarter with Nestle Health Science, Merck, Novartis, and two other top 25 pharma clients. Novartis was added to the ranks of CodeEvolver platform licensee which by the way is off to a solid start. And the tech transfer to upgrade Merck’s platform was completed, excellent widening and deepening of adoption in pharma manufacturing in the quarter. Outside pharma, new R&D projects were initiated with Tate & Lyle and one other new customer each in different non-sweetener food ingredient applications. In molecular diagnostics and molecular biology applications, we broke out with a combined R&D revenues in excess of $750,000 with two new clients in two separate and new applications. These have been under negotiated since -- under negotiation since late last year, so it's great to see these materialize in the quarter. And even better that they are on top of continued projections for our next generation sequencing enzymes to deliver significant sales starting later this year targeting molecular diagnostic applications. The blossoming of food and molecular biology and diagnostic applications in the quarter show that these markets are finally reaching inflection points for Codexis and the value creating proteins we can engineer for them. Capstoning the expansion of the customer base here at Codexis, I note that combining products with research revenues, we generated six-digit sales with 15 different customers in the second quarter, which is a record for the company. Second half sales are projected to be higher than first half sales as we maintain our full year revenue guidance of between $69 million and $72 million. New or significantly larger second half sales contributors on top of our solid first half phase include revenues recognized from the Novartis CodeEvolver license, and expected low single-digit million dollar milestone achievement from the backend of the GSK CodeEvolver license, growth of sales to Tate & Lyle for TASTEVA and plus growth of sales in molecular biology and diagnostics applications. In the Novel Biotherapeutics segment, there are not a lot of specifics to provide today, though progress is well on track with our 2019 plans. Nestle Health Science is lining up for CDX-6114's first phenylketonuria patient trials and the potential for a significant milestone to be earned by Codexis in 2020 if that is successful. And our pipeline of early stage enzyme therapy candidates continued to move ahead nicely in the quarter, including several recently generating positive preclinical proof-of-concept data readouts. More to come on the pipeline as we move to deliver on our core goal of achieving partnerable status for at least 2 of these programs at year-end. Before turning over the call to Gordon, I'd like to review our updated Codexis 2019 pipeline snapshot posted today to our website. As you can see on Slide 2, we've added nine net new projects to the pipeline during this past year. 13 new projects overwhelmed the four projects that dropped off the list due to inactivity over the past two years. The number of commercial installations grew by two from nine to 11 over the last year, the ultimate fruits of our sales cycle when our R&D engine is no longer needed, and we can generate sustained revenues and margins. Two new commercial installations this past year were enzymes for Tate & Lyle's TASTEVA M sweetener and for KYORIN's urinary incontinence drug Beova. And on Slide 4, you can see a 58% increase in the number of projects in our pipeline over the past two years, and a doubling of the number of projects from 26 to 52 over the past three years. At the more detailed level as shown on Slide 4, we are successfully expanding our pipeline across multiple industries and applications in parallel. For example, we have more than doubled the number of late-stage Phase II or Phase III projects over the last three years to 15 Codexis developed Performance Enzymes. Similarly, the number of performance enzyme projects in other industries has increased to 12 across three different industrial verticals. Finally, the number of projects that Codexis is self-funding in our pipeline has doubled over the past three years from six to 12. Notably, these programs have the prospects for generally larger economic rewards to Codexis than partner funded projects. And it is here that I'm pleased to note our expanded balance sheet capacity, which we can leverage to smartly invest in great opportunities. I'd like to extend a special thanks to Casdin Capital, which in June added to its ownership position in Codexis with a $50 million equity investment. I'm delighted to say that this private placement was completed very cost effectively without related expenses other than the standard legal fees. Let me now turn the call over to Gordon to provide more details on our Q2 financial results. Gordon?