Welcome to the Codexis Third Quarter 2023 Earnings Conference Call. [Operator Instructions]. Please note this even is being recorded. And now I'll turn the call over to Carrie McKim, Director of Investor Relations. Please go ahead.

Thank you, operator. With me today are Dr. Stephen Dilly, Codexis President and Chief Executive Officer; Kevin Norrett, Chief Operating Officer; and Sri Ryali, Chief Financial Officer. During this call, management will be making a number of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including our guidance for 2023 revenue, product revenues and gross margin on product revenues as well as our strategies and prospects for revenue growth and successful execution of current and future programs and partnerships, including our ECO Synthesis platform and pharmaceutical manufacturing business. To the extent that statements contained in this call are not descriptions of historical facts regarding Codexis, they are forward-looking statements reflecting the beliefs and expectations of management as of the statement date, November 2, 2023. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond Codexis' control and could materially affect actual results. Additional information about factors that could materially affect actual results can be found in Codexis' filings with the Securities and Exchange Commission. Codexis expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. And now, I’ll turn the call over to Stephen.

Thank you, Carrie, and thanks, everyone for joining. We approached the end of 2023 in a position of strength. We have a core pharmaceutical manufacturing business that generates cash, a potentially game changing technology in ECO Synthesis platform, and importantly for financial resources to execute on our plans. In financing our enhanced strategic focus in July, we've worked very hard to put ourselves in a position of financial security, so that we now have a path to potential positive cash flow around the end of 2026 with current financial resources. Let me briefly recap how we get that. It starts with a strong balance sheet. As you'll recall, over the last two years, we received a windfall of roughly $135 million in product revenue from the sale of CDX-616 to Pfizer for the manufacture of PAXLOVID. This was the result of our quick and meticulous execution supplied metric tons of products in support of the global pandemic. CDX-616 still represent the largest single commercial success to Codexis to date. And the extraordinary revenues that generated a central to the strong balance sheet we have today, with approximately $75 million in cash as of September 30. On top of that strong foundation, we've taken steps to dramatically reduce our cash burn by over 50% year-on-year. We did this by focusing our efforts on programs that will generate the greatest value, streamlining our organization to the right side for go-forward plan and consolidating operations to a single facility. We've also been working hard to return our core pharmaceutical manufacturing business with growth trajectory. And we're very pleased the progress and excited for the future growth potential. The cash generated by our pharma manufacturing business, combined with reduced cash burn and our strong balance sheet creates the opportunity to invest in our ECO…

Thanks, Steven. As mentioned, I was just in Amsterdam at the TIDES Europe meeting where I was energized by the high levels of interest we were seeing from potential customers and collaborators. Continued engagement with key players and decision makers has only reinforced my conviction that there is a very real need for our enzymatic solution. And with that a significant revenue opportunity for Codexis. Shifting to slide four, we look forward to sharing more detail on our recent technical progress in the coming months, and the December virtual KOL event even mentioned will be a terrific opportunity to hear directly from those in the RNAi space, who would benefit from this technology. In addition to welcoming John Maraganore to our SAB, we look forward to his participation in this event, where he will share his perspective on the growing importance of RNAi therapeutics as a class, today's manufacturing landscape and the need for innovation is RNAi Demand growth. The agenda will also feature discussions around the ECO Synthesis commercial opportunities, and a status update on our anticipated milestones, as well as a technical overview of the platform from Stefan Lutz, our Senior Vice President of Research. We believe this event will be a highly valuable resource for education around what we see as the major growth driver for Codexis. And we hope you'll plan to join us virtually in December. On slide five, I'd like to quickly recap our anticipated key milestones. As we approach the end of 2023, we are nearing the demonstration of grand scale synthesis with our ECO Synthesis technology. We will take a deeper dive into the significance of this key technological milestone during our December event, but at a high level, it means we plan to demonstrate the prepared to scale manufacture of an…

Thanks, Kevin. Good afternoon, everyone. Moving to slide six, released our full third quarter financial results. The press release earlier this afternoon is available on our Investor Relations a website where I call out a few highlights from the quarter. Let me first share some thoughts on our financial position. As Stephen noted, our strong balance sheet today reflects the benefits of a roughly $135 million windfall related to our CDX-616 sales to Pfizer for taxable good between 2021 and 2022. This injection of cash significantly bolstered our financial position and is reflected in our current cash balance for $74.6 million as of September 30. As part of the restructuring announced in July, we focused our money and our people on the priority programs with the highest potential to create value. And we took decisive action to reduce headcount and consolidate facilities. These decisions lowered our projected cash burn by more than half. We now expect annual burn of roughly $20 million to $30 million over the next few years. This along with the anticipated return to growth of our pharmaceutical manufacturing business in 2024 and expected commercial launch of ECO Synthesis platform is projected to fund our planned operations to positive cash flow, which we expect around the end of 2026. This is a good position to be in. Now, let me provide some brief comments on our Q3 results. During our July 20 call we guided that Q3 product revenue would be our lowest quarter, given the inherent lumpiness of the pharmaceutical manufacturing business, which is driven by timing of customer orders. That is exactly in line with what we saw this quarter. Total revenues excluding enzyme sales related to PAXLOVID were $9.3 million for the third quarter of 2023 compared to $21.5 million from the prior year.…

Thank you, Sri. In closing, I'm incredibly optimistic for the difficult decisions we made a few months ago have propositioned Codexis for long term success. We've streamlined the company and zeroed in on the killer app of our CodeEvolver platform, and we have the resources we need to realize the potentially massive value of our ECO Synthesis technology. Now we're in execution mode, and with a cascade of upcoming milestones, we look forward to keeping you up to date on our progress. With that, we'd be happy to take your questions. Operator?

Thank you. We will now be conducting a question and answer session. [Operator Instructions] Thank you. Our first question comes from the line of Brandon Couillard with Jefferies. Please proceed with your question.

Thanks, Good afternoon guys. Kevin or Stephen, could you elaborate a little bit more on the TIDES EU conference and some of the engagement you saw there? How do we go relative to expectations? And what were some of the reactions from potential customers that you engaged with there?

Yes, thanks, Brandon. I'm going to get Kevin to answer that because he's literally just back off the airplane looking to be jet lag. So, Kevin.

Thanks Stephen. Hi, Brandon. Yes, actually, it was quite exciting for multiple reasons. One, if you remember, in the May TIDES meeting, we really is first time we had come above the radar in terms of rolling out what we were working on behind the scenes for last year or so, which was the ECO Synthesis platform. What we demonstrated at TIDES and really generated a lot of excitement was that we've made significant progress since then in terms of showing increased coupling efficiency, longer strands of siRNA fragments, as well as improvements in some of the other pieces that are important across an enzymatic platform, which is also an important piece of having a fully enzymatic solution. So I think, customers and potential collaborators that were not as interested in talking to us in May are now really excited about talking to us, and we were quite popular at the conference. Sri, do you have anything?

Well, I think it's the nature of the customers.

Yes, I think the nature of the customers really, I mean, TIDES is a manufacturing focus conference. So you know, CDMOS and whatnot are really kind of the bulk of the clients there. And they're focused in terms of looking at a new alternative versus simply trying to improve phosphoramidite chemistry was completely shifted from there. I think that really summarizes why I came back super energized from this conference and look forward to sharing more information in May of next year.

Got you. Stephen, some of the experts we've talked to about enzymatic approaches, you question a few things like flexibility, volumetric productivity. How do you address those concerns? What are some, I guess, the timelines to be able to do that? And how do you think I guess, how do you respond to I guess some of those concerns about the approach in general?

Well, first one will be the volumetric productivity, which is actually the central premise of the enzymatic approach is it should have vastly improved. And that comes from the tethering of the enzyme and the having the oligo in solution. And so we actually expect our volumetric productivity to be significantly superior to the traditional chemical approach. But we need to show you the guys that. We start to do that at the December event, but some of the TIDES slide started the hints at that also will continually show more starting with TIDES Asia in March next year and then May back to TIDES U.S. again. So it's just going to be -- we want to show you what we've actually done rather than what we're hoping to do. But progress is good and the volumetric part of it is really nailed down. The other thing that we think is super important and actually, we have heard from even in your call, Brandon, was the need to address the building blocks as well. And so one of the things I think that really surprised people at TIDES is how far we've got on the enzymatic synthesis of the NQPs, as well as just putting them together into the oligos. And finally, when we announced our gram-scale milestone towards the end of this year, what we're going to be showing in that is flexibility and the inclusion of modified blocks in there. So, yes, this is why I keep saying, we're listening to what your state of the art is what we need to do, how we need to be competitive. And also, the other thing that we have heard is the intrinsic ability of the enzymatic route to go along is a competitive advantage that the phosphoramidite chemistry approach we'll find very hard to compete with. So yes, and again, that's one of the intrinsic advantages of our approach. But yes, they've been doing this for 40 years, we've been doing this for a year and a half, but we're very much on the same playing field now.

Great. I’ll hop in queue. Thanks.

And yes, you can tell from our general body language, we’re super excited.

Thank you. Our next question comes from Dan Urrea with Stifel. Please proceed with your question.

Hi, guys, it's actually Evan on for Dan. Thanks for the questions. The first one was actually just a simple modelling question. I mean, you're giving your guidance in terms of X product revenues, X PAXLOVID. Can you just remind me what your PAXLOVID enzyme or product revenue is for this year, and kind of which quarters those have or are going to fall into? Thanks.

I can answer that. We haven't booked any revenue related to sales of CDX-616 PAXLOVID, but this year. We are expecting to book $8 million in the fourth quarter. And that is part of the accounting for the retainer fee that's already been collected. So it's non-cash revenue. We'll see $8 million in Q4, there's another $9 million that will book in Q4 of 2024. And then we'll be done accounting for all of the PAXLOVID retainer fees.

And that's R&D, or that's enzyme sales?

That'll show up in product revenue.

Product revenue. Okay. And then, is there an R&D piece there as well that's, I guess, kind of not PAXLOVID but Pfizer related?

Yes, so in the second quarter, we booked $5 million. This is where Pfizer applied a portion of their credit to a new enzyme not related to PAXLOVID. It’s already been booked as R&D revenue, and that was incurred in last quarter.

Got you. Okay. So $8 million in 4Q and then another $9 million next year in 4Q and those are product revenues. Okay. Super helpful. We got that out of the way. Thanks. I guess the next question is what I want to ask? I wanted to ask about writes -- your write-down, it’s really kind of a double question or related. You took a write-down of some of your investments in the quarter. I think there's a three point something million dollar charge. So, I guess, which specific investments were those? And then just kind of related I know, you guys have relationships with Alphazyme and Molecular Assemblies, and I know Molecular Assemblies, you an investment and that's why it's related. What kind of status of the of those relationships?

I can start with the write-down question first. We did book roughly $4 million in impairments on investments in private life science companies that we hold. We have investments holds in our queue in MAI, SQL and Arzeda, the write-downs are related to SQL and Arzeda. And really, it's just a function of the fact that these are companies that have been active on the financing front, and anytime they do that, we have to reassess the value that they raise money at and appropriately reflect that on our financials.

And I'll cover the MAI and Alphazyme, two very different situations. But strangely enough, we've talked to both of them within the last couple of days. MAI, we have a fairly significant equity stake and you'll remember they're using our TDT enzyme version that does DNA and RNA to do DNA synthesis. They're making super good progress, technically, in terms of coming up with some very long, very pure DNA strands, we're super happy with that in that relationship. And really we're looking how we collaborate going forward. So that's very positive. Also, with Alphazyme, they've now become part of the broader [Merrivale] umbrella. We're talking to them. They have existing contracts in place with us. And we're also talking about going forward, how we can leverage that relationship. So that obviously being a small company trying to cover a broad landscape, there's a lot of collaborations in our future.

Got you. Thanks a lot for the question.

Thank you. Our next question comes from the line of Matt Hewitt with Craig-Hallum. Please proceed with your question.

Good afternoon, and thank you for the progress update. Maybe two for me. The first one, what is the -- as you look at, what is the biggest challenge to achieving gram-scale synthesis for ECO? And then separately, you're talking about getting maybe your some of your first orders later in the second half of next year, how should we be thinking about the size of those orders? Are these six figures? Are they seven figures? Just help us calibrate how big those initial orders can be? Obviously, we would expect those to scale and ramp higher over time. But where do we start? Thank you.

Great. So I'll cover the gram-scale synthesis question and Kevin, you’re going to talk about double-stranded ligase next year. So, with the gram-scale synthesis, it sounds like a very simple statement until you pull it apart and say, what does it actually mean? And what we're talking about here is making an appropriate quantity of a suitable length oligo that has the appropriate modifications in it under process conditions, with a reasonable purity and so on. And we've been making very strong progress on that, where we've reiterated our confidence in hitting that. Yep, I think the most interesting question will be, how long we actually go with the oligo by the end of this year, because we were already up with what we showed it TIDES was a very nice six-MER that we made, which is comparable to what some other companies were showing with phosphoramidite chemistry, in terms of its purity, and specifications, all the rest of it. But no one's ever run a TDT RNA oligo out to 15, 16, 17 yet. And we're hoping to do that relatively soon. So we can really understand the physical chemistry better. So that's the thing that I'm most excited about. But I've been super happy with things like the conversion efficiency of the enzyme in its present state, that the productivity, the reliability, the ability to include the modification. So we're, we're feeling like we're very much on track, and intrigued by how it performs that. Kevin?

Yes. And then you layer on top of that, it's important to note that Stephen mention the double-stranded RNA ligase. Already, ligation approaches are becoming more and more common within the phosphoramidite chemistry world, because phosphoramidite chemistry tends to fall down in the longer oligo range in terms of requirements of more input materials, it becomes a little less efficient, you get a higher impurity profile, the longer the strands. So a lot of companies have approached us around testing our RNA ligase in the first half of next year, so that they can look at making shorter all of those strands of phosphoramidite chemistry will really well and stitching together 10 Mers or five Mers and be able to get to siRNA strands in the 20 to 30 Mer range and maybe even a bit longer with the ligation. So when it comes to orders itself, though, we're talking about testing with customers in the first half of 2024 and looking at actual customer orders in the second half of 2024 based upon that experience. And the other thing I should mention, we also have two other customized double stranded RNA ligase programs that are wrapping up from an evolution standpoint, where we could see some additional orders for those customized programs, but we haven't put those supply agreements in place.

I mean, order of magnitude in terms of the size of those orders that you'd be happy with. I mean?

Well, I mean, I think from an individual enzyme standpoint, you know, double stranded RNA ligase is one piece it's still in the range of a total peak opportunity at least today without huge growth, towards the end of the decade if we're successful ECO Synthesis somewhere in the range of $15 million to $25 million enzyme opportunity. So by the end of this year with early launch maybe you could see some single digit millions in terms of ordering. But we'll put out more information around that as we get to our financial guidance for 2024. I think the other thing here really – I just going to say one more thing that, sorry, just to highlight like, This highlights how important it is that we have the cash run we have to be able to set the market correctly, with not only the double-stranded RNA ligase, but also the ECO Synthesis platform and getting that in the hands of customers for testing is coming in.

That's really helpful. Thank you.

Thank you. Our next question comes from the line of Chad Wiatrowski with TD Cowen. Please proceed with your question.

Hi, this is Chad on for Steven Mah. Just to follow up on Brandon's question on the ECO Synthesis flexibility. Did you guys present any data that the enzyme based approach allows the utilization of all the various modified nucleotides and analogues which can be used by chemical synthesis methods? And what about future modified bases? How easy would they be to think the integrated using the existing enzyme or with new enzymes that has to be engineered?

So thanks for the question, Chad. Yes, I mean, this is part of the sort of central driver of how we're evolving the TDT. And what we showed at TIDES was some very sort of relevant examples of current modifications, with furthering that in terms of our gram-scale synthesis. And the aim is that version 1.0 of ECO Synthesis covers the modifications currently in use. Now, we've always said that this is going to be to your analogy, like the iPhone or whatever else as newer more sort of strange, unnatural modifications come through, we may well have additional enzymes that we need to evolve to include that or further evolve the current TDT to add that to its armamentarium. There’s probably a law of diminishing returns with any single enzyme such that we will perfect around what currently exists with TDT 1.0, and then move on to some of the more innovative ones. And this is where Kevin and his team are really doing a lot of hard work to link up with innovated companies, they're often small companies that are looking at very new constructs. And you're learning about those and trying to stay current. And one of the big concepts about the alpha testing we've been talking about early next year, is to put our enzyme kit in their hands to see how it works under their conditions with their modification, and getting the feedback, right? And you can imagine the flexibility to this system, because the enzyme is tethered and the oligo moves is that you can pass it through more than one column to one of a better word. So you could have several TDT enzymes specified for the specific oligo that you're trying to make. And so we're very aware that one of the performance characteristics that we need to deliver beyond volumetric efficiency is flexibility and speed.

I might add just one thing there in that, you know, our assessment of the current products and development for siRNA, we're certainly great – there’s 400 products in development. So bear in mind, there may be some variation in this, but we see greater and 80% of them, including the two or three most common modifications, which are the two primal methyl and the two times, as well as the phosphonothioate on. So at the end of the day, that's what we wanted to demonstrate our ability to do that at times. And that was the first step. And we'll continue to build upon that as the modifications come out.

And we put the slide deck from TIDES up on our website. I think the presentation is going to be up within the next day or so, which is worth a look if you've got time.

Awesome. Yes. Looking forward to that and to the KOL event in December. Ahead of that event, are there any details you can share on John Maraganore opinion on the need for the ECO Synthesis? Was he involved in that strategy update or was he just added to the strategic advisory board recently? Thanks.

We've been talking to him for a little while. I mean, he's always told me that yes, he was saying we need an enzymatic solution even before he left being CEO of Alnylam a couple of years ago. And he's very much on board with what we're trying to do. But what we also need is rather than sort of just cheerleaders, we need people to keep us honest, in terms of what it would really take for someone to adopt this, this methodology, because, I was super serious about what I said in my comments, prepared comments, that there are going to be people sitting there weighing the decision about do I go the old safe tried route, the phosphoramidite chemistry and eat up the cost? Or do I try this new thing. And we've got to show I mean, reliability and dependability, and we've got a couple of books. Purity is going to be one of them. And the reduced capital investment is going to be another one. But they're all has to be based on rigor and meeting the specification, and doing it dependably and doing it repetitively. So all of that is front of mind and having people that are really sat in that seat advising us is super useful.

Thanks again for the questions.

Thank you. Our next question comes from the line of Brandon Couillard with Jefferies. Please proceed with your question.

Hi, thanks for the follow up. Just want to ask about your source of confidence in the pharma manufacturing business returning to growth in 2024. And whether that'd be a function of business with existing customers or new customers? Thanks.

Hi, Brandon, as we look at the forecast that we've been developing internally, specifically on 2024, you see growth coming from the pipeline, which we think is an important driver, we also see a normalization of ordering patterns from some of our big customers as well. So they both are contributing. As we progress throughout this decade, you'll see a bigger contribution of growth coming in from the pipeline. Like we said, this year has been sort of a reset year with PAXLOVID going away with one of our big products going through a recent product launch, which cause them to order prebuild inventory and then not order this year .Those patterns start to normalize. So we're confident of growth both for marketed products, as well as on the pipeline.

Maybe one other thing to add there, Brandon, I've been working a lot on is getting better at predicting that element. As well, we've added a couple of resources in the past six months here to be able to do better account management, follow up, et cetera, so that we can have a better perspective on the going forward forecasts. And you want to add there.

Just to add, I think we saw that with our expectations on Q3 that we set in July that this would be the low quarter and that's exactly what it turned out to be. And we're expecting Q4 to come in line to meet our full year guidance. So I think as Kevin said, we felt much better about understanding the dynamics of this business than we did say a year ago.

Thank you.

Thank you. There are no further questions at this time. I would like to turn the call back over to Stephen Dilly for his closing remarks.

Well, thanks again for joining us today. And as you can tell Sri and Kevin and I looking forward to a very busy fall. We'll be meeting many of you in person during our slate of. I think its five upcoming investor conferences over the next month or so. And of course, we also hope you'll be able to join us for the Eco Synthesis focused virtual KOL event on December the 8th. And you're thinking it's going to be a fantastic conversation. So that's all from us. And thank you very much for joining today.

This concludes today's call. You may now disconnect.