NASDAQ:CDXS Codexis Q3 2023 Earnings Report $2.30 -0.03 (-1.29%) As of 04/30/2025 04:00 PM Eastern Earnings HistoryForecast Codexis EPS ResultsActual EPS-$0.26Consensus EPS -$0.32Beat/MissBeat by +$0.06One Year Ago EPSN/ACodexis Revenue ResultsActual Revenue$9.28 millionExpected Revenue$10.96 millionBeat/MissMissed by -$1.68 millionYoY Revenue GrowthN/ACodexis Announcement DetailsQuarterQ3 2023Date11/2/2023TimeN/AConference Call DateThursday, November 2, 2023Conference Call Time4:30PM ETUpcoming EarningsCodexis' Q1 2025 earnings is scheduled for Thursday, May 1, 2025Conference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by Codexis Q3 2023 Earnings Call TranscriptProvided by QuartrNovember 2, 2023 ShareLink copied to clipboard.There are 9 speakers on the call. Operator00:00:00Welcome to Codexis Third Quarter 2023 Earnings Conference Call. Please note, this event is being recorded. And now, I'll turn the call over to Carrie McKim, Director of Investor Relations. Please go ahead. Speaker 100:00:23Thank you, operator. With me today are Doctor. Stephen Dilley, Codexis' President and Chief Executive Officer Kevin Norit, Chief Operating Officer and Sri Riali, 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, successful execution of current and future programs and partnerships, including our EcoSensys 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. Speaker 100:01:11You 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 that 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 Steven. Speaker 200:01:41Thank you, Carrie, and thanks everyone for joining. We approach 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 the ecosystem platform, and importantly the financial resources to execute on our plans. Since announcing 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 The potential positive cash flow around the end of 2026 with current financial resources. Let me briefly recap how we get there. Speaker 200:02:22It starts with a strong balance sheet. As you'll recall, over the last 2 years, we received a windfall of roughly $135,000,000 in product revenue from the sale of CDX-six sixteen to Pfizer for the manufacturer of axlovid. This was the result of our quick and meticulous execution to supply metric tons of product in support of the global pandemic. CDX-six sixteen still represents the largest single commercial success for Codexis to date and the extraordinary revenues it generated are central to the strong balance sheet we have today with approximately $75,000,000 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. Speaker 200:03:16We did this by focusing our efforts on programs that would generate the greatest value, streamlining our organization to the right size for our go forward plan and consolidating operations to a single facility. We've also been working hard to return our core pharmaceutical manufacturing business for growth trajectory and we're very pleased with 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 EcoSynthesis technology to bring it to commercialization within our existing resources. The first element of the ECOSYNSIS platform, the double stranded RNA ligase should start to generate revenue next year, followed by anticipated early commercial licenses in 2025 and the rollout of the complete Ecosynthesis platform in 2026. Putting all these pieces together, cash balance, reduced burn, growth in pharmaceutical manufacturing and the Citing commercial potential of the EcoSynthesis platform gives us a path to potential positive cash flow around the end of 2026, The Ecosynthesis Technology, many of our team members just returned from presenting on our technical progress at the Tides Europe meeting. Speaker 200:04:51Our confidence in the revenue potential of this opportunity is increasing as we continue our conversations with potential partners and experts. As an adjunct to those conversations, we're in the process of forming a strategic advisory board to make sure that we have the best possible understanding of the existing and future landscape so that the EcoSynthesis platform is tailored to meet the real needs of the market. We are truly delighted and honored to welcome John Maragonore as our inaugural external SAB member. As Founder and Chief Executive Officer of Alnylam Pharmaceuticals, John pioneered the translation of RNAi from a laboratory tool into an A highly new class of medicine. Alongside his participation in our Strategic Advisory Board, We also look forward to hearing John's perspective on the RNAi therapeutics landscape during our upcoming ecosyphysis focused virtual KOL event in December. Speaker 200:05:57Before I hand it over to Kevin to outline that event, let me briefly recap the reasons enthusiasm about the Ecosynthesis platform. Moving to Slide 3. Drug developers are continuing to advance pipelines of innovative RNAi therapeutics for large disease indications like Alzheimer's and hypertension, and there is a projected wave of coming demand. The current manufacturing standard of ceramolite chemistry is dependable, well established and will no doubt continue to play an important role in the landscape. However, At commercial scale, it also requires enormous capital investment, extensive lead time and high volumes of toxic solvents like acetonitrile. Speaker 200:06:45For reference, a leading contract manufacturing organization recently invested $725,000,000 to Our market research indicates that demand is expected to grow to approximately 30,000 kilos annually by around the end of the decade. It would take 1,000,000,000 of dollars and many more of these plants to meet that capacity. Most companies don't have the resources That's where an elegant enzymatic solution like the EcoSynthesis platform comes in. Today, we're closing in on an aqueous based Working process designed to complement bostromidec chemistry and vastly reduce the level of capital investment required for large scale production. As with any disruptive technology, it would be naive to think that Codexis will command the entire market with our platform. Speaker 200:07:53So we're thinking critically about where exactly our technology fits within the existing manufacturing landscape. In many cases that might look like augmenting the chemical approach with our double stranded RNA ligase, which can stitch together short strands of RNA that have been chemically synthesized. This enables much more efficient use of existing facilities and we currently have collaborations with a few key RNAi players in this In other cases, the ECOSYNSIS platform could be used to synthesize the complete siRNA. And sometime, the best approach will be a combination of the EcoSynthesis platform, ligation and even chemistry. That strategic optionality and flexibility is one of the beauties of our platform and underscores why Ecosynthesis has such promising potential to play a Critical role in meeting future demand for siRNA. Speaker 200:08:50Now while continuing to refine and perfect technical piece is important. We also need to pay full attention to the real life barriers to adoption of our platform. Put bluntly, why will innovators trust our technology to deliver their valuable siRNA assets when they have a seemingly reliable alternative in phosphoramodact chemistry. For those already developing RNAi therapeutics, it's about demonstrating the levels of purity we can produce and the ease of adoption we can facilitate. For those who aren't, we need to emphasize how the EcoSynthesis platform opens the door for smaller companies to develop RNAi therapeutics for large indications key decision makers weigh their options. Speaker 200:09:42So it's incumbent on us to help our customers and the investment community understand the need for an enzymatic solution. We think our December virtual KOL event will play a critical role in this ongoing market education process. To cover additional detail on that and our recent business development efforts, I'll pass it over to Kevin, who has just returned from the Tides Europe meeting. Kevin? Speaker 300:10:08Thanks, Steven. As mentioned, I was just in Amsterdam at the Tides Europe meeting where I was energized by the high levels of interest and with that a significant revenue opportunity for Codexis. Shifting to Slide 4, We look forward to sharing more detail on our recent technical progress in the coming months and the December virtual KOL event Steven mentioned will be a terrific opportunity to hear 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. And a status update on our anticipated milestones as well as a technical overview of the platform from Stephan 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. Speaker 300:11:30On Slide 5, I'd like to quickly recap our anticipated key milestones. As we approach the end of 2020 We are nearing the demonstration of gram scale synthesis with our ecosystem 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 And we plan to do this all under process like conditions. This proof point represents the first step from an R and D project Something with potential commercial applications and it would enable us to enter pre commercial testing with select customers next year, followed by early commercial licenses of the technology anticipated in 2025. During those phases, we will collect valuable feedback to inform any necessary In parallel to that progress, we also plan to make In addition to providing a nearer term RNA synthesis market entry point for us, this product gets our foot in the door with many of the customers currently using for phosphoramidite chemistry, but requiring ligation based approaches for longer sequences. Speaker 300:12:58This is a meaningful first step in educating customers on the benefits Our financial results for the quarter, let me provide an update on our business development activities following our strategic pivot in July. We are in active discussions with Nestle to restructure our collaboration whereby they continue to develop CDX-seven 100 and 8 Codexis retains an economic interest in this program, but is no longer sharing in the clinical development and commercialization costs. We expect the potential deal would follow traditional path for Phase 1 molecule with an upfront payment, clinical milestones and sales based growth. We are also in active negotiations with other potential partners to monetize assets within the segments of our life sciences portfolio where we will no longer be focused, such as genomics and PCR based diagnostics. This is consistent with our previously announced strategy to leverage partners with broader channel reach and accelerate value to Codexis. Speaker 300:14:06We anticipate that we will be able to execute 1 or more of these deals by the end of this year early next year and we look forward to keeping you updated on that progress. Speaker 400:14:15With that, I'll turn the call over to Shri. Thanks, Kevin. Good afternoon, everyone. Moving to Slide 6. We released our full Q3 financial results in a press release earlier this afternoon, which available on our Investor Relations website. Speaker 400:14:31Before 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 benefit of a roughly $135,000,000 windfall related to our CDX-six sixteen sales to Pfizer for PAXLOVID between 2021 2022. This injection of cash significantly bolstered our financial position and is reflected in our current cash balance of $74,600,000 Speaker 500:15:01as of Speaker 400:15:04As 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 $20,000,000 to $30,000,000 over the next 2 years. This along with the anticipated return to growth of our Pharmaceutical Manufacturing business in 2024 and expected commercial launch of the Ecosynthesis platform 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. Speaker 400:15:47Now let me provide some brief comments on our Q3 results. During our July 20 call, we guided that Q3 product revenue It 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 $9,300,000 for the Q3 of 2023 compared to $21,500,000 from the prior year. Product revenues excluding sales related to PAXLOVID were $5,400,000 for the 3rd quarter compared to $15,100,000 for the prior year. The decline is largely due to timing of customer orders, including specific customer building pre launch inventory in the Q3 of 2022, ahead of the anticipated approval of a pharmaceutical product. Speaker 400:16:43However, we expect Q4 product revenues to be more in line with Q1 and Q2 of this year. We are confident in reiterating our full year 2023 product revenue guidance of $30,000,000 to $35,000,000 With the Paxlovid windfall now behind us, 2023 has been a reset year for the pharmaceutical manufacturing business. As we approach the end of this year, we are increasingly confident that this business is on a path to return to sustained growth beginning in 2024. And we plan to provide additional detail during our full year 2023 financial results call. Now turning to R and D revenues, we reported $3,900,000 in Q3 compared to $6,400,000 last year. Speaker 400:17:28This decrease is driven by the completion of work on the Takeda partnered programs and the winding down of our biotherapeutics programs following our decision to exit this space. As a reminder, our BioTherapeutics R and D revenues reflect the reimbursement of approximately 50% of our costs. So while the decision to exit BioTherapeutics will result in lower R and D revenues, removing these costs actually improves our bottom line by reducing overall cash burn. We continue to expect 2023 R and D revenues to be in the range of $21,000,000 to $24,000,000 Product gross margin, excluding enzyme sales related to PAXLOVAN, was 58% this quarter compared to 55% In the Q3 of 2022, we continue to expect 2023 project product gross margin to be in the range of 55% to 65%. Briefly turning to expenses. Speaker 400:18:26R and D expenses for the Q3 of compared to $13,500,000 in the Q3 of 2022. Compared to both the prior year and last quarter, You can see reductions across R and D and SG and A expenditures resulting from our financial discipline. You can expect to see the continued benefit the decisive actions we've taken in the Q4 with continued lower expenses. You'll notice this quarter that our Q3 GAAP expenses included large one time charges. These primarily relate to the restructuring we announced in July. Speaker 400:19:11We booked a $3,100,000 charge related to the reduction in force and a $10,000,000 non cash impairment charge reflecting our decision to exit biotherapeutics and consolidate our facilities. Finally, as you can see in the other income and expense line in the table on this slide, recorded one time non cash impairments related to certain investments we previously made in private life science companies. Shifting to Slide 7, to recap, we are in a strong financial position. We are confident in reiterating our 2023 guidance And we have laid up the foundation for our Pharmaceutical Manufacturing business to return to sustained growth in 2024. Looking ahead, we have positioned ourselves well with the path to potential positive cash flow expected around the end of 2026. Speaker 400:20:03And we look forward to providing further guidance during our full year 2023 financial results call. I'll now turn the call back to Stephen. Speaker 200:20:13Thank you, Sri. In closing, I'm incredibly optimistic that the difficult decisions we made a few months ago have positioned 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 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? Operator00:21:27Our first question comes from the line of Brandon Couillard with Jefferies. Please proceed with your question. Speaker 500:21:44Some of the engagement you saw there, how did it go relative to expectations and what were some of the reactions from potential customers that you engage through up there? Speaker 200:21:54Yes. Thanks, Brandon. I'm going to get Kevin to answer that because he's literally just back off the airplane looking soon to be jet lagged. So Kevin. Speaker 300:22:03Thanks, Stephen. Hi, Brandon. Yes, actually it was quite exciting for multiple reasons. One, If you remember in the Meitides meeting, we really it's the first time we had come above the radar in terms of rolling out what we were working on behind the scenes for the last So, which was the Ecosensus 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. Speaker 300:22:48So I think customers and potential collaborators that were not I was interested in talking to us in May, are now really excited about talking to us and we were quite popular at the conference. Speaker 200:23:02Well, I think it's the nature of the customers. Speaker 300:23:05Yes. I think the nature of the customers really, I mean Tides is A manufacturing focused conference. So CDMOs and whatnot are really kind of the bulk of the clients there and their focus In terms of looking at a new alternative versus simply trying to improve phosphorammonite chemistry was completely shifted from that. I think that really summarizes why I came back super energized from this conference and look forward to sharing more information in May of Speaker 500:23:38Stephen, some of the experts we've talked to about enzymatic approaches, Your question a few things like flexibility, volumetric productivity. How do you address those concerns? What are some, I guess, the Time lines 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? Speaker 200:23:59Well, 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 We start to do that at the December event, but some of the Tides slide started to hint at that. Also, we'll continually show more starting with Tides Asia in March next year and then May back to Tides U. S. Speaker 200:24:44Again. 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 your calls, 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 oligo. Speaker 200:25:19And finally, when we announce 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 So, yes, this is why I keep saying we're listening to what the 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 long It's a competitive advantage that the phosphoramide chemistry approach will 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. Speaker 200:26:09But we're very much on the same playing field now. Great. Speaker 500:26:13I'll hop back in queue. Thanks. Speaker 200:26:19Yes, you can tell from our general body language, we're super excited here. Yes. Operator00:26:26Thank you. Our next question comes from Dan Arias with Stifel. Please proceed with your question. Speaker 600:26:34Hey, guys. This is actually Evan on for Dan. Thanks for the questions. The first one is actually just a simple modeling question. I mean, you're giving your guidance in terms of ex product revenues ex Paxlovid. Speaker 600:26:49Can 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. Sure. Yes, I Speaker 400:27:04can answer that. This is Shreed. We haven't booked any Revenue related to the sales of CDX-six sixteen for PAXLOVID this year. We are expecting to book $8,000,000 in the 4th And that is part of the accounting for the retainer fee that's already been collected. So it's non cash revenue. Speaker 400:27:23We'll see $8,000,000 in Q4. There's another $9,000,000 that will book in Q4 of 2024 and then we'll be done accounting for all of the tax COVID retainer fees. Speaker 600:27:35Okay. And that's all that's R and D or that's enzyme sales? Speaker 400:27:39That will show up in product revenue. Speaker 600:27:42Product revenue. Okay. And then is there an R and D piece there as well that I that's I guess kind of map packs a little bit Pfizer related? Speaker 400:27:52Yes. So in the Q2, we booked $5,000,000 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 and D revenue and that was incurred in the last quarter. Speaker 600:28:05Got you. Okay. So $8,000,000 in 4Q And then another $9,000,000 next year in 4Q and those are product revenues. Okay, super helpful. Got that out of the way. Speaker 600:28:18I guess the next question is, what do I want to ask? I wanted to ask about right, so you're write down of it's really just kind of a double question related. You took a write down of some of your investments In the quarter, I think it was a $3,700,000 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. Speaker 600:28:55I know molecular assemblies you have an investment and that's why it's related. What's kind of the status of those relationships? Speaker 400:29:05I can start with the write down question first. We did book roughly $4,000,000 in impairments on investments in private life science companies that we hold. We have investments closed in our queue In MAI, Sequel and Arzeta, the write downs are related to Sequel and Arzeta. And really it's just a function of the fact that these are companies that I've 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. Speaker 200:29:35And I'll cover the MAI and Alphazyme, 2 very different situations, but strange enough we've talked to both of them within the last couple of days. MAI, we have a fairly significant equity stake in. And you'll remember, they're using our TDT enzyme version that does DNA, not 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 and that relationship. And really, we're looking how we collaborate going forward. So that's very Positive. Speaker 200:30:15Also with Alphazyme, they've now become part of the broader Maravai 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 Yes. Obviously, being a small company trying to cover a broad landscape, there's a lot of collaborations in our future. Operator00:30:44Our next question comes from the line of Matt Hewitt with Craig Hallum. Please proceed with your question. Speaker 700:30:52Good afternoon and thank you for the progress update. Maybe 2 for me. The first one, what is the as you look at it, what is the biggest challenge To achieving gram scale synthesis for ECO? And then separately, you're talking about getting maybe 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 they 6 figures? Speaker 700:31:16Are they 7 figures? Just help us calibrate How big those initial orders could be? Obviously, we would expect those to scale and ramp higher over time, but where do we start at? Thank you. Speaker 200:31:28Great. 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 GramScale synthesis, it sounds like a very simple set 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. Speaker 200:32:09We've reiterated our confidence in hitting that. I think the most interesting question will be how long we actually go with the oligo by the end of this year. Because We're already up. What we showed at Tides was a very nice 6 mill that we made, which is sort of comparable to what some other companies were showing with phosphorhabditite chemistry in terms of its purity and Specification to all the rest of it. But no one's ever run a TDT RNA oligo out to 15, 16, 17 yet. Speaker 200:32:48And 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 tethered state, The productivity, the reliability, the ability to include the modifications. So we're feeling like we're very much on track and intrigued by how it performs, Kevin. Speaker 300:33:19Yes. And then you layer on top of that, It's important to note that Stephen mentioned the double stranded RNA ligase. Already ligation approaches are becoming more and more common within the phosphorammonite chemistry world because phosphorammonite chemistry tends to fall down in the longer oligo range in terms of Requirement of more input materials, it becomes a little less efficient. You get a higher impurity profile the longer the strand. 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 phosphoraminated chemistry works really well and stitching together 10 MERS or 5 MERS and be able to get to siRNA strands in the with customers in the first half of twenty twenty four and looking at actual customer orders in the second half of twenty twenty four based upon that experience. Speaker 300:34:25And then we the other thing I should mention, we also have 2 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. And order of magnitude in terms of the size Speaker 200:34:45of those orders that you'd be happy with? I mean Speaker 300:34:48Well, I mean, I think from an individual enzyme standpoint, double 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 important thing here really is just I was just going to say one more thing, Matt. Sorry, just to highlight like this highlights how important it is that we have the cash runway we have now to be able to set the market correctly with not only the double stranded RNA ligase, but also the EcoSensus platform and getting that in the hands of customers for testing this coming year. Operator00:35:54Thank you. Our next question comes from the line of Chad Wieczynski with TD Cowen. Please proceed with your question. Speaker 800:36:05Hey, this is Chad on for Steven Ma. Just to follow-up on Brandon's question on the ecosystem flexibility. Speaker 600:36:13Do you Speaker 800:36:13guys present any data that the enzyme based approach allows the utilization of all the various modified nucleosides and analogs, And what about future modified bases? How easy would they be to The integrated using the existing enzyme or what new enzymes have to be engineered? Speaker 200:36:35Thanks 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. We're furthering that in terms of our gram scale synthesis. Speaker 200:36:54And The aim is that Version 1.0 of EcoSynthesis covers the modifications currently in use. Now we've always said that this is going to be choose 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. But There's probably a law of diminishing returns with any single enzyme such that we will get a perfect around what currently exists And this is where Kevin and his team are really doing a lot of hard work To link up with innovative 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 Put our enzyme kit in their hands to see how it works under their conditions with their modification And getting the feedback, right? Speaker 200:38:08And you can imagine that one of the flexibilities of this system because the enzyme is tethered and the oligo moves Is that you can pass it through more than one column for want of a better word. So you could have several PDT 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. Speaker 300:38:40I might add just one thing there in that our of the current products in development for siRNA, certainly great. I mean, there's 400 products in development. So bear in mind, There may be some variation in this, but we see greater than 80% of them including the 2 or 3 most common modifications, which are The 2 prime o methyl and the 2 prime, fluoros as well as the phosphorothiolate bond. So At the end of the day, that's why we wanted to demonstrate our ability to do that at Tides and that was the first step and we'll continue to build upon that as new modifications come out. Speaker 200:39:18Yes. 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. Speaker 800:39:32Awesome. Yes, looking forward to that and To the KOL event on in December, ahead of that event, are there any details you can share on John Maraganore's opinion on the need For the Ecosynthesis, was he involved in that strategy update or Speaker 200:39:46was 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 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. Speaker 200:40:11But what we also need is rather than sort of Cheerleaders, we need people to keep us honest in terms of what it would really take for someone to adopt 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 Do I go the old safe tried route of phosphoramide 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 hooks. Purity is going to be one of them. And the reduced capital investment is going to be another one, but they all has to be based on rigor and meeting the specification I'm doing it dependably and doing it repetitively. Speaker 200:41:00So all of that is front of mind and having people that are really Operator00:41:15Thank you. Our next question comes from the line of Brandon Couillard with Jefferies. Please proceed with your question. Speaker 500:41:25Thanks for the follow-up. Just wanted to ask about your source of confidence in the Pharma Manufacturing business returning to growth in 'twenty four, Speaker 400:41:42Hey, Brandon. As we look at the forecast that we've been developing internally, specifically on 2024, we 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. Speaker 400:42:04Like we said, this year has been sort of a reset year with Tax loaded going away with one of our big products going through a recent product launch, which caused them to order pre build inventory and then not This year, those patterns start to normalize. So we're confident of growth both for marketed products as well as on the pipeline. Speaker 300:42:22Maybe one other thing to add there, Brennan that Tree and I have been working a lot on is getting better at predicting that element as well. We've added a couple of resources In the past 6 months here to be able to do better account management, follow-up, etcetera, so that we can have a better perspective on the going forward forecast. And Speaker 400:42:42Just to add, I think you saw that with our expectations on Q3 that we said 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, in line to meet our full year guidance. So I think as Kevin said, we feel Much better about understanding the dynamics of this business than we did say a year ago. Operator00:43:11Thank you. There are no further questions at this time. I would like to turn the call back over to Stephen Dilley for closing remarks. Speaker 200:43:24Well, thanks again for joining us today. And as you can tell, Sri and Kevin and I are looking forward to a very busy fall. We'll be meeting many of you in person during our slate of I think it's 5 upcoming investor conferences over the next month or so. And of course, we also hope you'll be able to join us for the EcoSynthesis focused virtual KOL event on December 8. And you're thinking it's going to be a fantastic conversation. Speaker 200:43:50So that's all from us and thank you very much for joining today.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallCodexis Q3 202300:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsSlide DeckPress Release(8-K)Quarterly report(10-Q) Codexis Earnings HeadlinesCodexis to Report First Quarter 2025 Financial Results on May 14April 30 at 4:15 PM | globenewswire.comCodexis (CDXS) Projected to Post Quarterly Earnings on ThursdayApril 29 at 3:47 AM | americanbankingnews.comMassive new energy source found in UtahNEW THIS WEEK: Huge Energy Discovery In Utah The Department of Energy say it could power America for millions of years. And both grizzled oilmen and clean energy supporters love it: Energy Secretary Chris Wright called it "an awesome resource," while Warren Buffett, Jeff Bezos, Mark Zuckerberg, and Bill Gates are all directly invested.May 1, 2025 | Stansberry Research (Ad)Major Investment Alert: Opaleye Management Inc. Boosts Stake in Codexis!April 9, 2025 | tipranks.comCodexis Announces Board Member Retirement in April 2025April 9, 2025 | tipranks.comCodexis Announces Byron Dorgan to Retire from Board of DirectorsApril 9, 2025 | globenewswire.comSee More Codexis Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Codexis? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Codexis and other key companies, straight to your email. Email Address About CodexisCodexis (NASDAQ:CDXS) discovers, develops, and sells enzymes and other proteins. The company operates through two segments, Performance Enzymes and Novel Biotherapeutics. It offers biocatalyst products and services. The company also provides biocatalyst screening and protein engineering services. In addition, it offers CodeEvolver, a technology platform, which helps in developing and delivering biocatalysts that perform chemical transformations and enhance the efficiency and productivity of manufacturing processes. The company's platform is also used for molecular biology and in vitro diagnostic enzymes. It has a collaboration agreement with Nestlé Health Science to develop CDX-7108 for the treatment of exocrine pancreatic insufficiency. The company sells its products to pharmaceutical manufacturers through its direct sales and business development force in the United States and Europe. The company was incorporated in 2002 and is headquartered in Redwood City, California.View Codexis ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Amazon's Earnings Will Make or Break the Stock's Comeback CrowdStrike Stock Nears Record High, Dip Ahead of Earnings?Alphabet Rebounds After Strong Earnings and Buyback AnnouncementMarkets Think Robinhood Earnings Could Send the Stock UpIs the Floor in for Lam Research After Bullish Earnings?Texas Instruments: Earnings Beat, Upbeat Guidance Fuel RecoveryMarket Anticipation Builds: Joby Stock Climbs Ahead of Earnings Upcoming Earnings Airbnb (5/1/2025)Apple (5/1/2025)Amazon.com (5/1/2025)Amgen (5/1/2025)Linde (5/1/2025)MercadoLibre (5/1/2025)Monster Beverage (5/1/2025)Strategy (5/1/2025)Atlassian (5/1/2025)Arthur J. 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There are 9 speakers on the call. Operator00:00:00Welcome to Codexis Third Quarter 2023 Earnings Conference Call. Please note, this event is being recorded. And now, I'll turn the call over to Carrie McKim, Director of Investor Relations. Please go ahead. Speaker 100:00:23Thank you, operator. With me today are Doctor. Stephen Dilley, Codexis' President and Chief Executive Officer Kevin Norit, Chief Operating Officer and Sri Riali, 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, successful execution of current and future programs and partnerships, including our EcoSensys 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. Speaker 100:01:11You 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 that 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 Steven. Speaker 200:01:41Thank you, Carrie, and thanks everyone for joining. We approach 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 the ecosystem platform, and importantly the financial resources to execute on our plans. Since announcing 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 The potential positive cash flow around the end of 2026 with current financial resources. Let me briefly recap how we get there. Speaker 200:02:22It starts with a strong balance sheet. As you'll recall, over the last 2 years, we received a windfall of roughly $135,000,000 in product revenue from the sale of CDX-six sixteen to Pfizer for the manufacturer of axlovid. This was the result of our quick and meticulous execution to supply metric tons of product in support of the global pandemic. CDX-six sixteen still represents the largest single commercial success for Codexis to date and the extraordinary revenues it generated are central to the strong balance sheet we have today with approximately $75,000,000 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. Speaker 200:03:16We did this by focusing our efforts on programs that would generate the greatest value, streamlining our organization to the right size for our go forward plan and consolidating operations to a single facility. We've also been working hard to return our core pharmaceutical manufacturing business for growth trajectory and we're very pleased with 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 EcoSynthesis technology to bring it to commercialization within our existing resources. The first element of the ECOSYNSIS platform, the double stranded RNA ligase should start to generate revenue next year, followed by anticipated early commercial licenses in 2025 and the rollout of the complete Ecosynthesis platform in 2026. Putting all these pieces together, cash balance, reduced burn, growth in pharmaceutical manufacturing and the Citing commercial potential of the EcoSynthesis platform gives us a path to potential positive cash flow around the end of 2026, The Ecosynthesis Technology, many of our team members just returned from presenting on our technical progress at the Tides Europe meeting. Speaker 200:04:51Our confidence in the revenue potential of this opportunity is increasing as we continue our conversations with potential partners and experts. As an adjunct to those conversations, we're in the process of forming a strategic advisory board to make sure that we have the best possible understanding of the existing and future landscape so that the EcoSynthesis platform is tailored to meet the real needs of the market. We are truly delighted and honored to welcome John Maragonore as our inaugural external SAB member. As Founder and Chief Executive Officer of Alnylam Pharmaceuticals, John pioneered the translation of RNAi from a laboratory tool into an A highly new class of medicine. Alongside his participation in our Strategic Advisory Board, We also look forward to hearing John's perspective on the RNAi therapeutics landscape during our upcoming ecosyphysis focused virtual KOL event in December. Speaker 200:05:57Before I hand it over to Kevin to outline that event, let me briefly recap the reasons enthusiasm about the Ecosynthesis platform. Moving to Slide 3. Drug developers are continuing to advance pipelines of innovative RNAi therapeutics for large disease indications like Alzheimer's and hypertension, and there is a projected wave of coming demand. The current manufacturing standard of ceramolite chemistry is dependable, well established and will no doubt continue to play an important role in the landscape. However, At commercial scale, it also requires enormous capital investment, extensive lead time and high volumes of toxic solvents like acetonitrile. Speaker 200:06:45For reference, a leading contract manufacturing organization recently invested $725,000,000 to Our market research indicates that demand is expected to grow to approximately 30,000 kilos annually by around the end of the decade. It would take 1,000,000,000 of dollars and many more of these plants to meet that capacity. Most companies don't have the resources That's where an elegant enzymatic solution like the EcoSynthesis platform comes in. Today, we're closing in on an aqueous based Working process designed to complement bostromidec chemistry and vastly reduce the level of capital investment required for large scale production. As with any disruptive technology, it would be naive to think that Codexis will command the entire market with our platform. Speaker 200:07:53So we're thinking critically about where exactly our technology fits within the existing manufacturing landscape. In many cases that might look like augmenting the chemical approach with our double stranded RNA ligase, which can stitch together short strands of RNA that have been chemically synthesized. This enables much more efficient use of existing facilities and we currently have collaborations with a few key RNAi players in this In other cases, the ECOSYNSIS platform could be used to synthesize the complete siRNA. And sometime, the best approach will be a combination of the EcoSynthesis platform, ligation and even chemistry. That strategic optionality and flexibility is one of the beauties of our platform and underscores why Ecosynthesis has such promising potential to play a Critical role in meeting future demand for siRNA. Speaker 200:08:50Now while continuing to refine and perfect technical piece is important. We also need to pay full attention to the real life barriers to adoption of our platform. Put bluntly, why will innovators trust our technology to deliver their valuable siRNA assets when they have a seemingly reliable alternative in phosphoramodact chemistry. For those already developing RNAi therapeutics, it's about demonstrating the levels of purity we can produce and the ease of adoption we can facilitate. For those who aren't, we need to emphasize how the EcoSynthesis platform opens the door for smaller companies to develop RNAi therapeutics for large indications key decision makers weigh their options. Speaker 200:09:42So it's incumbent on us to help our customers and the investment community understand the need for an enzymatic solution. We think our December virtual KOL event will play a critical role in this ongoing market education process. To cover additional detail on that and our recent business development efforts, I'll pass it over to Kevin, who has just returned from the Tides Europe meeting. Kevin? Speaker 300:10:08Thanks, Steven. As mentioned, I was just in Amsterdam at the Tides Europe meeting where I was energized by the high levels of interest and with that a significant revenue opportunity for Codexis. Shifting to Slide 4, We look forward to sharing more detail on our recent technical progress in the coming months and the December virtual KOL event Steven mentioned will be a terrific opportunity to hear 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. And a status update on our anticipated milestones as well as a technical overview of the platform from Stephan 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. Speaker 300:11:30On Slide 5, I'd like to quickly recap our anticipated key milestones. As we approach the end of 2020 We are nearing the demonstration of gram scale synthesis with our ecosystem 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 And we plan to do this all under process like conditions. This proof point represents the first step from an R and D project Something with potential commercial applications and it would enable us to enter pre commercial testing with select customers next year, followed by early commercial licenses of the technology anticipated in 2025. During those phases, we will collect valuable feedback to inform any necessary In parallel to that progress, we also plan to make In addition to providing a nearer term RNA synthesis market entry point for us, this product gets our foot in the door with many of the customers currently using for phosphoramidite chemistry, but requiring ligation based approaches for longer sequences. Speaker 300:12:58This is a meaningful first step in educating customers on the benefits Our financial results for the quarter, let me provide an update on our business development activities following our strategic pivot in July. We are in active discussions with Nestle to restructure our collaboration whereby they continue to develop CDX-seven 100 and 8 Codexis retains an economic interest in this program, but is no longer sharing in the clinical development and commercialization costs. We expect the potential deal would follow traditional path for Phase 1 molecule with an upfront payment, clinical milestones and sales based growth. We are also in active negotiations with other potential partners to monetize assets within the segments of our life sciences portfolio where we will no longer be focused, such as genomics and PCR based diagnostics. This is consistent with our previously announced strategy to leverage partners with broader channel reach and accelerate value to Codexis. Speaker 300:14:06We anticipate that we will be able to execute 1 or more of these deals by the end of this year early next year and we look forward to keeping you updated on that progress. Speaker 400:14:15With that, I'll turn the call over to Shri. Thanks, Kevin. Good afternoon, everyone. Moving to Slide 6. We released our full Q3 financial results in a press release earlier this afternoon, which available on our Investor Relations website. Speaker 400:14:31Before 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 benefit of a roughly $135,000,000 windfall related to our CDX-six sixteen sales to Pfizer for PAXLOVID between 2021 2022. This injection of cash significantly bolstered our financial position and is reflected in our current cash balance of $74,600,000 Speaker 500:15:01as of Speaker 400:15:04As 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 $20,000,000 to $30,000,000 over the next 2 years. This along with the anticipated return to growth of our Pharmaceutical Manufacturing business in 2024 and expected commercial launch of the Ecosynthesis platform 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. Speaker 400:15:47Now let me provide some brief comments on our Q3 results. During our July 20 call, we guided that Q3 product revenue It 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 $9,300,000 for the Q3 of 2023 compared to $21,500,000 from the prior year. Product revenues excluding sales related to PAXLOVID were $5,400,000 for the 3rd quarter compared to $15,100,000 for the prior year. The decline is largely due to timing of customer orders, including specific customer building pre launch inventory in the Q3 of 2022, ahead of the anticipated approval of a pharmaceutical product. Speaker 400:16:43However, we expect Q4 product revenues to be more in line with Q1 and Q2 of this year. We are confident in reiterating our full year 2023 product revenue guidance of $30,000,000 to $35,000,000 With the Paxlovid windfall now behind us, 2023 has been a reset year for the pharmaceutical manufacturing business. As we approach the end of this year, we are increasingly confident that this business is on a path to return to sustained growth beginning in 2024. And we plan to provide additional detail during our full year 2023 financial results call. Now turning to R and D revenues, we reported $3,900,000 in Q3 compared to $6,400,000 last year. Speaker 400:17:28This decrease is driven by the completion of work on the Takeda partnered programs and the winding down of our biotherapeutics programs following our decision to exit this space. As a reminder, our BioTherapeutics R and D revenues reflect the reimbursement of approximately 50% of our costs. So while the decision to exit BioTherapeutics will result in lower R and D revenues, removing these costs actually improves our bottom line by reducing overall cash burn. We continue to expect 2023 R and D revenues to be in the range of $21,000,000 to $24,000,000 Product gross margin, excluding enzyme sales related to PAXLOVAN, was 58% this quarter compared to 55% In the Q3 of 2022, we continue to expect 2023 project product gross margin to be in the range of 55% to 65%. Briefly turning to expenses. Speaker 400:18:26R and D expenses for the Q3 of compared to $13,500,000 in the Q3 of 2022. Compared to both the prior year and last quarter, You can see reductions across R and D and SG and A expenditures resulting from our financial discipline. You can expect to see the continued benefit the decisive actions we've taken in the Q4 with continued lower expenses. You'll notice this quarter that our Q3 GAAP expenses included large one time charges. These primarily relate to the restructuring we announced in July. Speaker 400:19:11We booked a $3,100,000 charge related to the reduction in force and a $10,000,000 non cash impairment charge reflecting our decision to exit biotherapeutics and consolidate our facilities. Finally, as you can see in the other income and expense line in the table on this slide, recorded one time non cash impairments related to certain investments we previously made in private life science companies. Shifting to Slide 7, to recap, we are in a strong financial position. We are confident in reiterating our 2023 guidance And we have laid up the foundation for our Pharmaceutical Manufacturing business to return to sustained growth in 2024. Looking ahead, we have positioned ourselves well with the path to potential positive cash flow expected around the end of 2026. Speaker 400:20:03And we look forward to providing further guidance during our full year 2023 financial results call. I'll now turn the call back to Stephen. Speaker 200:20:13Thank you, Sri. In closing, I'm incredibly optimistic that the difficult decisions we made a few months ago have positioned 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 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? Operator00:21:27Our first question comes from the line of Brandon Couillard with Jefferies. Please proceed with your question. Speaker 500:21:44Some of the engagement you saw there, how did it go relative to expectations and what were some of the reactions from potential customers that you engage through up there? Speaker 200:21:54Yes. Thanks, Brandon. I'm going to get Kevin to answer that because he's literally just back off the airplane looking soon to be jet lagged. So Kevin. Speaker 300:22:03Thanks, Stephen. Hi, Brandon. Yes, actually it was quite exciting for multiple reasons. One, If you remember in the Meitides meeting, we really it's the first time we had come above the radar in terms of rolling out what we were working on behind the scenes for the last So, which was the Ecosensus 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. Speaker 300:22:48So I think customers and potential collaborators that were not I was interested in talking to us in May, are now really excited about talking to us and we were quite popular at the conference. Speaker 200:23:02Well, I think it's the nature of the customers. Speaker 300:23:05Yes. I think the nature of the customers really, I mean Tides is A manufacturing focused conference. So CDMOs and whatnot are really kind of the bulk of the clients there and their focus In terms of looking at a new alternative versus simply trying to improve phosphorammonite chemistry was completely shifted from that. I think that really summarizes why I came back super energized from this conference and look forward to sharing more information in May of Speaker 500:23:38Stephen, some of the experts we've talked to about enzymatic approaches, Your question a few things like flexibility, volumetric productivity. How do you address those concerns? What are some, I guess, the Time lines 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? Speaker 200:23:59Well, 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 We start to do that at the December event, but some of the Tides slide started to hint at that. Also, we'll continually show more starting with Tides Asia in March next year and then May back to Tides U. S. Speaker 200:24:44Again. 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 your calls, 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 oligo. Speaker 200:25:19And finally, when we announce 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 So, yes, this is why I keep saying we're listening to what the 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 long It's a competitive advantage that the phosphoramide chemistry approach will 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. Speaker 200:26:09But we're very much on the same playing field now. Great. Speaker 500:26:13I'll hop back in queue. Thanks. Speaker 200:26:19Yes, you can tell from our general body language, we're super excited here. Yes. Operator00:26:26Thank you. Our next question comes from Dan Arias with Stifel. Please proceed with your question. Speaker 600:26:34Hey, guys. This is actually Evan on for Dan. Thanks for the questions. The first one is actually just a simple modeling question. I mean, you're giving your guidance in terms of ex product revenues ex Paxlovid. Speaker 600:26:49Can 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. Sure. Yes, I Speaker 400:27:04can answer that. This is Shreed. We haven't booked any Revenue related to the sales of CDX-six sixteen for PAXLOVID this year. We are expecting to book $8,000,000 in the 4th And that is part of the accounting for the retainer fee that's already been collected. So it's non cash revenue. Speaker 400:27:23We'll see $8,000,000 in Q4. There's another $9,000,000 that will book in Q4 of 2024 and then we'll be done accounting for all of the tax COVID retainer fees. Speaker 600:27:35Okay. And that's all that's R and D or that's enzyme sales? Speaker 400:27:39That will show up in product revenue. Speaker 600:27:42Product revenue. Okay. And then is there an R and D piece there as well that I that's I guess kind of map packs a little bit Pfizer related? Speaker 400:27:52Yes. So in the Q2, we booked $5,000,000 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 and D revenue and that was incurred in the last quarter. Speaker 600:28:05Got you. Okay. So $8,000,000 in 4Q And then another $9,000,000 next year in 4Q and those are product revenues. Okay, super helpful. Got that out of the way. Speaker 600:28:18I guess the next question is, what do I want to ask? I wanted to ask about right, so you're write down of it's really just kind of a double question related. You took a write down of some of your investments In the quarter, I think it was a $3,700,000 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. Speaker 600:28:55I know molecular assemblies you have an investment and that's why it's related. What's kind of the status of those relationships? Speaker 400:29:05I can start with the write down question first. We did book roughly $4,000,000 in impairments on investments in private life science companies that we hold. We have investments closed in our queue In MAI, Sequel and Arzeta, the write downs are related to Sequel and Arzeta. And really it's just a function of the fact that these are companies that I've 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. Speaker 200:29:35And I'll cover the MAI and Alphazyme, 2 very different situations, but strange enough we've talked to both of them within the last couple of days. MAI, we have a fairly significant equity stake in. And you'll remember, they're using our TDT enzyme version that does DNA, not 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 and that relationship. And really, we're looking how we collaborate going forward. So that's very Positive. Speaker 200:30:15Also with Alphazyme, they've now become part of the broader Maravai 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 Yes. Obviously, being a small company trying to cover a broad landscape, there's a lot of collaborations in our future. Operator00:30:44Our next question comes from the line of Matt Hewitt with Craig Hallum. Please proceed with your question. Speaker 700:30:52Good afternoon and thank you for the progress update. Maybe 2 for me. The first one, what is the as you look at it, what is the biggest challenge To achieving gram scale synthesis for ECO? And then separately, you're talking about getting maybe 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 they 6 figures? Speaker 700:31:16Are they 7 figures? Just help us calibrate How big those initial orders could be? Obviously, we would expect those to scale and ramp higher over time, but where do we start at? Thank you. Speaker 200:31:28Great. 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 GramScale synthesis, it sounds like a very simple set 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. Speaker 200:32:09We've reiterated our confidence in hitting that. I think the most interesting question will be how long we actually go with the oligo by the end of this year. Because We're already up. What we showed at Tides was a very nice 6 mill that we made, which is sort of comparable to what some other companies were showing with phosphorhabditite chemistry in terms of its purity and Specification to all the rest of it. But no one's ever run a TDT RNA oligo out to 15, 16, 17 yet. Speaker 200:32:48And 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 tethered state, The productivity, the reliability, the ability to include the modifications. So we're feeling like we're very much on track and intrigued by how it performs, Kevin. Speaker 300:33:19Yes. And then you layer on top of that, It's important to note that Stephen mentioned the double stranded RNA ligase. Already ligation approaches are becoming more and more common within the phosphorammonite chemistry world because phosphorammonite chemistry tends to fall down in the longer oligo range in terms of Requirement of more input materials, it becomes a little less efficient. You get a higher impurity profile the longer the strand. 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 phosphoraminated chemistry works really well and stitching together 10 MERS or 5 MERS and be able to get to siRNA strands in the with customers in the first half of twenty twenty four and looking at actual customer orders in the second half of twenty twenty four based upon that experience. Speaker 300:34:25And then we the other thing I should mention, we also have 2 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. And order of magnitude in terms of the size Speaker 200:34:45of those orders that you'd be happy with? I mean Speaker 300:34:48Well, I mean, I think from an individual enzyme standpoint, double 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 important thing here really is just I was just going to say one more thing, Matt. Sorry, just to highlight like this highlights how important it is that we have the cash runway we have now to be able to set the market correctly with not only the double stranded RNA ligase, but also the EcoSensus platform and getting that in the hands of customers for testing this coming year. Operator00:35:54Thank you. Our next question comes from the line of Chad Wieczynski with TD Cowen. Please proceed with your question. Speaker 800:36:05Hey, this is Chad on for Steven Ma. Just to follow-up on Brandon's question on the ecosystem flexibility. Speaker 600:36:13Do you Speaker 800:36:13guys present any data that the enzyme based approach allows the utilization of all the various modified nucleosides and analogs, And what about future modified bases? How easy would they be to The integrated using the existing enzyme or what new enzymes have to be engineered? Speaker 200:36:35Thanks 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. We're furthering that in terms of our gram scale synthesis. Speaker 200:36:54And The aim is that Version 1.0 of EcoSynthesis covers the modifications currently in use. Now we've always said that this is going to be choose 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. But There's probably a law of diminishing returns with any single enzyme such that we will get a perfect around what currently exists And this is where Kevin and his team are really doing a lot of hard work To link up with innovative 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 Put our enzyme kit in their hands to see how it works under their conditions with their modification And getting the feedback, right? Speaker 200:38:08And you can imagine that one of the flexibilities of this system because the enzyme is tethered and the oligo moves Is that you can pass it through more than one column for want of a better word. So you could have several PDT 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. Speaker 300:38:40I might add just one thing there in that our of the current products in development for siRNA, certainly great. I mean, there's 400 products in development. So bear in mind, There may be some variation in this, but we see greater than 80% of them including the 2 or 3 most common modifications, which are The 2 prime o methyl and the 2 prime, fluoros as well as the phosphorothiolate bond. So At the end of the day, that's why we wanted to demonstrate our ability to do that at Tides and that was the first step and we'll continue to build upon that as new modifications come out. Speaker 200:39:18Yes. 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. Speaker 800:39:32Awesome. Yes, looking forward to that and To the KOL event on in December, ahead of that event, are there any details you can share on John Maraganore's opinion on the need For the Ecosynthesis, was he involved in that strategy update or Speaker 200:39:46was 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 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. Speaker 200:40:11But what we also need is rather than sort of Cheerleaders, we need people to keep us honest in terms of what it would really take for someone to adopt 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 Do I go the old safe tried route of phosphoramide 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 hooks. Purity is going to be one of them. And the reduced capital investment is going to be another one, but they all has to be based on rigor and meeting the specification I'm doing it dependably and doing it repetitively. Speaker 200:41:00So all of that is front of mind and having people that are really Operator00:41:15Thank you. Our next question comes from the line of Brandon Couillard with Jefferies. Please proceed with your question. Speaker 500:41:25Thanks for the follow-up. Just wanted to ask about your source of confidence in the Pharma Manufacturing business returning to growth in 'twenty four, Speaker 400:41:42Hey, Brandon. As we look at the forecast that we've been developing internally, specifically on 2024, we 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. Speaker 400:42:04Like we said, this year has been sort of a reset year with Tax loaded going away with one of our big products going through a recent product launch, which caused them to order pre build inventory and then not This year, those patterns start to normalize. So we're confident of growth both for marketed products as well as on the pipeline. Speaker 300:42:22Maybe one other thing to add there, Brennan that Tree and I have been working a lot on is getting better at predicting that element as well. We've added a couple of resources In the past 6 months here to be able to do better account management, follow-up, etcetera, so that we can have a better perspective on the going forward forecast. And Speaker 400:42:42Just to add, I think you saw that with our expectations on Q3 that we said 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, in line to meet our full year guidance. So I think as Kevin said, we feel Much better about understanding the dynamics of this business than we did say a year ago. Operator00:43:11Thank you. There are no further questions at this time. I would like to turn the call back over to Stephen Dilley for closing remarks. Speaker 200:43:24Well, thanks again for joining us today. And as you can tell, Sri and Kevin and I are looking forward to a very busy fall. We'll be meeting many of you in person during our slate of I think it's 5 upcoming investor conferences over the next month or so. And of course, we also hope you'll be able to join us for the EcoSynthesis focused virtual KOL event on December 8. And you're thinking it's going to be a fantastic conversation. Speaker 200:43:50So that's all from us and thank you very much for joining today.Read morePowered by