MRVI - NASDAQ

Good afternoon, ladies and gentlemen, and welcome, everyone, to the Maravai LifeSciences Third Quarter 2024 Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speaker’s remarks, there will be a question-and-answer session. [Operator instructions] Thank you. I would now like to turn the call over to Deb Hart. Please go ahead.

Thank you. Good afternoon, everyone. Thanks for joining us on our third quarter 2024 earnings call. Our press release and the slides accompanying today's call are posted on our website and available at investors.maravai.com. As you can see from our agenda on Slide 2, Trey Martin, Chief Executive Officer; and Kevin Herde, Chief Financial Officer, are joining me today. Drew Burch, President of Nucleic Acid Production; and Becky Buzzeo, our Executive Vice President and Chief Commercial Officer, will join the call for the question-and-answer session following the prepared remarks. We remind you that management will make forward-looking statements and refer to GAAP and non-GAAP financial measures during today's call. It is possible that actual results could differ from management's expectations. We refer you to Slide 3 for more information about those forward-looking statements and our use of non-GAAP financial measures. Our just issued press release provides reconciliations to the most directly comparable GAAP measures. Please also refer to Maravai's SEC filings for additional information on the risks and uncertainties that may impact our operating results, performance and financial condition. Now I'll turn the call over to Trey.

Thank you, Deb, and good afternoon, everyone. We appreciate you joining our call today. I'll give a quick recap of the third quarter and provide some commentary on the market dynamics we are experiencing. I'll then provide a few business updates and discuss our plans to acquire the DNA and RNA business of Officinae Bio. Let's start with our third quarter results on Slide 5. Today, we reported $65 million in revenue, $13 million in total adjusted EBITDA and a loss of $0.02 in adjusted fully diluted earnings per share. Our Nucleic Acid Production or NAP segment had revenue of $50 million. Biologics Safety Testing or BST, had revenue of $15 million. Q3 results were slightly below our expectations, primarily due to a few customer requested program timing shifts, muted demand in research and discovery products within our NAP businesses and persistent softness in the global biologics market, which impacted our BST segment. In our NAP businesses, we recently achieved a key milestone, celebrating our largest service build to date at our Wateridge site, consisting of 26 grams of mRNA material for a preclinical cell and gene therapy customer. This program was initially slated for completion during Q3, but was delayed by 1 week into Q4 at the customer's request. Therefore, only a portion of the service revenue was recognized in Q3 versus the full amount we had assumed in our forecast. We will recognize the remainder of the revenue related to this program in Q4. This is an example of the way customers' clinical program timing can affect our service revenue realization. We also commenced our first customer build at Flanders 2, meeting another major milestone in our NAP segment. You'll see some photos on Slide 6. This program is for a cell and gene therapy customer using mRNA as an ex vivo tool to create the therapy. The engineering run is complete and work is underway preparing for batch 1 of GMP during Q4. We remain committed to advancing the field by playing a key role in the development of mRNA-based in vivo gene editing, gene-edited cell therapies, protein replacement therapies, cancer vaccines and infectious disease vaccines. Flanders 2 codifies this commitment to our customers through Phase III and commercial production. The fact that this customer chose to be the very first in our new facility is a testament to their confidence in our team's capabilities, expertise and commitment to high quality, and we are delivering on all fronts. We've built a robust funnel for GMP services for our Flanders 2 facility and are excited to be underway producing our first revenue in Q3. In the near term, I would expect the revenue contribution from Flanders to be a bit lumpy as we scale up. Similar to the customer requested delay at Wateridge in Q3, a Flanders 2 customer with a Q4 scheduled service build has requested to move the program to early 2025 due to clinical trial delays on their end. Our enhanced commercial team is working diligently with our customer funnel to fill capacity in the near term. We're encouraged by research that shows improved biotech financing and healthy new program starts in the industry related to our NAP businesses. However, we continue to transition through a period of contracting mRNA clinical trial starts, led by the steady annual decreases of new COVID mRNA vaccine and therapeutic clinical trials. Let's turn to Slide 7 to understand what I mean by that. The chart on the left side of the slide shows mRNA clinical trials initiated each year. As you can see, 2021 saw the highest number of trials initiated, but a very high percentage, 77% of those were related to COVID-19 vaccines and therapeutics. You can see those decline by about 20% each year for the past few years. The good news is that during this time frame, the non-COVID mRNA trials represented by the orange portion of the chart have steadily increased each year and are up 29% year-to-date through Q3. At some point, indication diversity will overcome the impact of the COVID-driven decline in starts, and we believe the COVID program proportional impact is nearly behind us. We believe we are the innovation leader and well positioned to service the growing segments of mRNA therapeutics discovery and development. The right chart shows clinical trials initiated for guide RNA-mediated gene editing, which is an exciting emerging opportunity for us. This market has been primarily CAR-Ts using lentiviral delivery approaches. However, developers are increasingly choosing mRNA as the preferred Cas delivery vehicle. We can and do support this market from RUO to GMP inputs and with RUO to commercial scale production across Wateridge and now Flanders 2. As you can see, this market growth is far outpacing prior years, up 75% year-to-date through Q3. Gene editing is a market we're excited about as a driver for our future growth potential. In both charts, this data reflects new program starts, not total active programs. Our research shows that total mRNA programs continue to increase, and we are now tracking close to 1,500 active programs. We will continue to focus on innovation to move the industry forward and build new revenue streams as a leading supplier, mRNA producer and raw material supplier. In that regard, I'd like to highlight 3 areas on Slide 8. Within our NAP business segment, we've introduced 21 new products year-to-date and continue to drive innovation as a critical KPI for our return to growth strategy. We've expanded our discovery mRNA synthesis services offerings with new custom sets of mRNA, providing flexible options that customers need for screening and hit-to-lead optimization. This plate-based mRNA launch supports our efforts to enable and lead the field by launching sets of up to 96 mRNA constructs. These custom mRNA construct libraries enable the testing of multiple candidate sequences with different combinations of 5 prime caps, modified NTPs and poly(A) tails, all with industry-leading cost and turnaround times. This new service enables our customers to optimize the performance of their specific targets, accelerating their development and improving the efficacy of life-changing mRNA-based therapeutics. Notably, this quarter, Alphazyme and TriLink collaborated to launch CleanScribe RNA Polymerase. The CleanScribe RNA Polymerase is a novel enzyme that catalyzes the in vitro transcription or IVT of a recombinant gene regulated by the T7 promoter. During the IVT reaction, dsRNA can be produced as a byproduct and trigger undesirable inflammatory responses in the cells. The CleanScribe enzyme dramatically reduces double-stranded RNA formation during the IVT compared to wild-type T7 RNA Polymerase, which is the current industry standard. This new product reduces double-stranded RNA by up to 85% and is positioned to help our customers develop safer, more potent mRNA therapeutics. Furthermore, we and our customers have found that this product is a very natural and easy substitution into existing IVT protocols and does not require extensive rework or further workflow optimization to achieve the exceptional performance. This product's robustness, reproducibility and double-stranded RNA reduction make it ideal for mRNA synthesis, self-amplifying RNA synthesis, RNA probe preparation and RNA construct development for additional studies. In addition to improving the final product, it further improves the economic and process advantages that already make co-transcriptional capping with CleanCap, the preferred approach for producing mRNA. Initial feedback on CleanScribe has been very positive. In fact, a top pharma customer shared that they saw a 50% reduction in double-stranded RNA in their self-amplifying IVT process. This impressed them so much they plan to switch over to CleanScribe as their default enzyme for self-amplifying RNA production. Alphazyme continues to work closely with TriLink and external partners to collaborate on the next generation of enzymes. As with CleanScribe, next-generation enzymes have the potential to boost the efficiency, yield and cost effectiveness of mRNA marketing -- manufacturing, excuse me, and we are committed to being the innovation leader in this area. Finally, we expanded our TriLink-owned IP around co-transcriptional capping technology with the issuance of an additional patent in the U.S. We now hold over 20 U.S. and international patents on our CleanCap capping technology. Let's turn to Slide 9. We continue to foster key academic partnerships to enhance innovation and accelerate market adoption of the latest technologies. We currently have active research collaborations with 9 top-tier academic institutions, some of which are listed here. The most recent is our collaboration with the University of California, San Diego. We believe investing in new product innovation and partnering with leading academic and industry partners is a key driver for creating long-term value. Now let's turn to Slide 10 and discuss the pending acquisition of Officinae Bio. We have signed a definitive agreement to acquire the DNA and RNA businesses of Officinae Bio. Officinae is a provider of precision DNA and RNA services through an AI-driven digital platform that automates and iteratively improves large and complex DNA assembly from oligos to gene fragments, mRNA synthesis and downstream cell-based screening. The team includes bioinformatics and data scientists developing end-to-end software and synthesis automation solutions, enabling the design, build, test cycles for mRNA therapeutics candidate discovery. During the discovery phase, customers need to be able to experiment and develop multiple constructs as they test to find the most promising candidate to advance to the next phase. Today, there are many barriers to efficiently and effectively moving through these phases, and Officinae has created a solution set that enables this process. Just as our Alphazyme acquisition expanded our offering for mRNA transcription tools and key enzymes, Officinae will enhance our mRNA offering for early phase discovery work. The addition of Officinae's front-end development and production expertise is expected to add complementary capabilities to Maravai's NAP product portfolio and allow us to offer our customers even more complete and timelier mRNA solutions. As has been the case with our past acquisitions, Officinae is a founder-led and comprised of an experienced team focused on cutting-edge science, bioinformatics and software services. We expect this acquisition will accelerate and derisk our e-commerce road map, enable mRNA discovery offerings and portfolio attachment and access differentiated mRNA design and bioprocess optimization capabilities to enhance our customer experience using AI and machine learning. As many of you are aware, our TriLink Discovery business unit is focused on working with customers at the front end of the drug development funnel. TriLink Discovery includes all research use only products and services, including all reagents, our custom chemistry business and mRNA manufacturing for screening and target discovery. This is where the majority of our TriLink customers are today in the discovery and preclinical stage and why this acquisition fits so well. The Officinae front-end ordering platform is expected to provide TriLink customers with a home for construct design and integrates a full catalog of cap and novel chemistries. We believe the addition of this e-commerce and AI offering will help our TriLink Discovery customers get to the next stage of development faster and more effectively with the best possible candidates. We know our ability to provide end-to-end service from sequence to drug product is a resounding value proposition for customers' choice. With the acquisition of Officinae, our enzyme portfolio expansion through Alphazyme, our TriLink Discovery products and TriLink GMP capabilities, we can incorporate raw materials and production expertise into our end-to-end service and supply offering, which is totally unique in the industry. Now let's turn to Slide 11 and highlight innovation within the Biologics Safety Testing segment. In collaboration with the TriLink team, Cygnus launched the first kit in their new generation of DNA quantification products, the CHO AccuRes kit. This residual host cell DNA quantification kit and all future kits in this portfolio include a probe-based master mix that contains TriLink's CleanAmp dNTPs and the Hot Start Taq DNA Polymerase. The assay has higher sensitivity and specificity than the industry standards, and the kits will help biopharma manufacturers ensure drug safety and stability for their patients. The Cygnus DNA extraction kit, which is sold separately, be used to isolate the residual DNA from any cell line. The resulting purified DNA can be quantified in its corresponding DNA amplification and quantification kit. The CHO AccuRes kit is the first of many products we have in development to grow our host cell DNA portfolio, and we expect to launch 2 more products in this portfolio by the end of the year. Like the Alphazyme and TriLink launch of the CleanScribe RNA Polymerase, this new product demonstrates collaboration between our brands as the Cygnus DNA extraction kits use TriLink's CleanAmp technology. Now turning to Slide 12. We've continued to evolve through what we knew would be a transition year in 2024. As we prepare for 2025, we believe we have innovative technologies, have built the right capabilities and infrastructure and are in the right markets to position us to achieve long-term growth. We've expanded our market position throughout the year with the industry and academic partnerships and look forward to welcoming the Officinae team when the acquisition closes. I remain excited about our future, our capabilities and what we can achieve together with the mission to make a meaningful impact in improving human health through the next generation of medicines. I'll now ask Kevin to provide details on our third quarter performance and our updated guidance. Kevin?

Thank you, Trey, and good afternoon, everyone. Starting on Slide 14. As you saw in our press release this afternoon, our Q3 2024 revenues were $65 million, slightly below our expectations for the quarter. Both business segments lagged our expectations with the NAP segment impacted by softer CleanCap demand in both RUO and GMP businesses as well as the customer requested delay of a preclinical program build. Our BST performance continues to be pressured by a soft bioprocessing market backdrop. In the third quarter, we took a GAAP noncash goodwill impairment charge of $154 million as we revisited our long-term model assumptions for all of our business units. The write-down is related to our TriLink business unit within our NAP segment, specifically the write-down of goodwill associated with the acquisitions of TriLink and MyChem. Our GAAP-based net loss for the amount attributable to noncontrolling interests was $176 million for the third quarter of 2024, with $154 million of that associated with the noncash goodwill impairment charge. As for earnings per share, both our GAAP basic and diluted EPS were a $0.70 per share loss, while adjusted fully diluted EPS was a $0.02 per share loss for the quarter. Adjusted EBITDA, a non-GAAP measure, was $13 million for Q3 2024, up from $12 million in Q3 2023. Our adjusted EBITDA margin was 20% in Q3 2024. That brings our year-to-date adjusted EBITDA, a non-GAAP measure, to $37.5 million and adjusted EBITDA margin of 18%. Turning to Slide 15. We ended Q3 with $578 million in cash, up $5 million from the end of the second quarter based on $13 million in cash flow provided by operations in the quarter and our CapEx was $8 million in the quarter. Gross debt, which has a term until late 2027 is at $529 million, resulting in a net cash position of nearly $50 million. As you may have seen via our 8-K filed in October, we amended and extended the revolving credit facility component of our overall debt position, increased the maturity by up to 5 years. And we slightly lowered the overall revolver from $180 million to $167 million. Based on the changing interest rate environment, the pending expiry of our interest rate cap in Q1 2025 and our view of the M&A landscape, we are actively reviewing our current debt structure, which has a maturity on the term loan in about 3 years. As you are aware, we have managed a grossed up structure to be opportunistic with M&A and also have the ability to voluntarily pay down our term loan. Thus, we have tremendous flexibility here. For the first 9 months of 2024, our net interest expense sits at $15 million on an average balance of around $530 million in debt or an annualized effective rate of under 4%. Now turning to Slide 16, I'll provide some more insights into our business segment financial performance for the quarter. The Nucleic Acid Production business revenues were $50 million in the quarter, representing 77% of the company's total revenue. NAP generated $15 million in adjusted EBITDA in the quarter for a segment margin of 31%. Our Biologics Safety Testing business revenues were $15 million in the quarter, contributing 23% of our total revenues. Our BST contributed $11 million of adjusted EBITDA, a margin of 72% in the quarter. Corporate expenses that are not included in the segment adjusted EBITDA totals I just spoke to were $14 million in the quarter, continuing to trend downward from recent quarters. Now turning to Slide 17 and updated financial guidance for 2024. Overall, I'd say it's been a frustrating year as it relates to our overall financial performance, particularly on the revenue line. I say it's frustrating as we've accomplished many of our key goals and initiatives from both an operational and strategic perspective, but have yet to see that reflected in our financial results. For example, for 2024, we're surpassing our targets related to new product introduction launches, customer mRNA turnaround time, on-time delivery, while strengthening our position in the key academic market and adding more unique capabilities with the Officinae acquisition. We believe our core product market share remains strong, but we have been impacted by the continued market weakness globally in bioprocessing as well as a challenging NAP market based on the void of large orders we have historically seen from pipeline progression. We've also been impacted by the reprioritization and timeliness of customers' programs. I think for most of our space, 2024 continues to be impacted by global macro pressures that have impacted buying decisions and created a challenge to return to growth. That said, we remain committed to making the best decisions to set Maravai for long-term success. We believe strongly that we are positioning our business to be a critical part of the broader ecosystem in which we participate, and we'll continue to lean forward into the great opportunity that we believe our addressable markets present. We are lowering our expected range of revenues for 2024 to between $255 million and $265 million. At the midpoint, this is a $15 million or 5% reduction in anticipated revenues for the year. This reduction results from a $5 million shortfall to our internal expectations for Q3 and about a $10 million lower outlook for most -- the most likely outcome for Q4. The lowered Q4 estimate is due to the shift of some customers' GMP programs initially slated for 2024 being pushed to 2025. Additionally, the large CleanCap orders we have historically seen dropping into our results have not occurred at the anticipated rate and our current order book entering Q4 leads us to a lower and more cautious outlook for the quarter in our NAP segment. In our BST segment, revenue for China was up nearly 30% from Q2 2024, but still not back to historical levels. We anticipate the lower level of BST revenues we saw in Q3 to also be impacted as usual by end of the year manufacturing slowdowns. To break down the updated full year revenue guide, we expect the Nucleic Acid Production segment to be around $193 million to $202 million. We expect to see our Biologics Safety Testing revenues this year to be about $62 million to $63 million, shifting to a full year that will be now down in the low single digits versus 2023. Based on this updated full year guidance and the $203 million that are in the books thus far, the resulting expectations for the fourth quarter are for total revenues between $52 million and $62 million, with the NAP segment at around $43 million at the midpoint and the BST segment to be around $14 million or so at the midpoint of our range for Q4. As a result of the lower revenue expectations, the high variable contribution margins of our business and a forecast for slightly higher cost of sales expense based on less favorable manufacturing variances, for 2024, we have updated our estimated earnings metrics. We now anticipate adjusted EBITDA margin to be 16% to 18% on this updated revenue guidance. The 400 basis point decline from our previous midpoint of 21% is mostly due to lower revenue projections in our higher-margin products, including GMP products in NAP and lower revenues for our high-margin BST segment. Additionally, we expect the following additional financial expectations as listed on Slide 17. Interest expense, net of interest income between $20 million and $25 million, depreciation and amortization between $45 million and $50 million, stock-based compensation, which we show as a reconciling item from GAAP to non-GAAP EBITDA to be approximately $50 million. This also includes an as a fully converted share count of about 254 million shares, and adjusted effective tax rate of 24%, and we see our net capital expenditures to be around $30 million for the year. Before I turn it back to Trey, I want to mention that we plan to close the acquisition of Officinae around the beginning of 2025 and thus do not see it impacting our financial results for 2024. As it relates to fiscal year 2025, we believe it's prudent to focus on closing out our current year, working with our customers and leadership teams to best assess 2025 and then provide financial guidance with our first quarter in 2025. I'll now turn it back over to Trey.

Thanks, Kevin. So to wrap up our prepared remarks on Slide 19, though market conditions remain challenging in the near term, we are confident in the long-term growth rates of our target markets and believe we offer differentiated technology, products and services. We expect to close Officinae acquisition early next year, and we'll continue looking for inorganic investments and additional partnerships to bolster our market position and provide our customers with additional solutions to accelerate our growth. We are encouraged by the pipeline progression we see for mRNA, gene editing and cell and gene therapies, and we believe the new clinical trial starts bode well for long-term growth in our markets. Our strong balance sheet, strong cash position and manageable debt position gives us strategic flexibility, and we will remain diligent in our cost control and operational efficiency. We are committed to building a strong foundation for long-term profitable and sustainable growth of our base businesses. Kevin, Becky, Drew and I are happy to answer your questions. So now I'll turn the call back to the operator for instructions.

[Operator Instructions] Your first question comes from the line of Dan Leonard with UBS.

You've talked about a firm commitment number throughout the year. How much of that firm commitment is now left by Q4?

Yes. So Dan, it's coming in as anticipated here in the third quarter and then the fourth quarter. We have roughly another $14 million to ship in the fourth quarter tied to committing to fulfilling that original expectation, Dan.

Okay. And then just my follow-up, Kevin, the sequential decline in NAP from about -- I think it was $49 million in Q3, $50 million rounding to $43 million at the midpoint for Q4. How much of that is the project push you mentioned into 2025 versus a weaker market?

Yes. It's probably -- the project push probably a couple of million dollars we get -- we go-to-market being the remainder.

Your next question comes from the line of Justin Bowers with Deutsche Bank.

Justin, are you there?

Pardon, I was on mute. What are -- can you talk about some of the swing factors for 4Q as it relates to the NAPs business? Realistically, there's probably 6 weeks or 7 weeks in the quarter left in the Western world. And then just a quick follow-up would be, is there any revenue associated with the acquisition for 2025 or is that just a technology acquisition?

Yes, sure. I'll start. I'll take the second question first. Yes, Officinae is predominantly a software acquisition for us and putting their front end onto our TriLink Discovery platform. And that's really what we want to do there, the sort of buy versus build decision, both from the exceptional platform they have as well as the timing to get that plugged in into market. They do have a business. They do have revenues. It will be -- we're talking low single-digit millions and a business, again, that is self-funding, meaning it's not going to be dilutive to our overall business. So a small group, but I think they formed something that's really unique, and it fits perfectly into our acquisition model of finding good, unique founder-based companies with great technology to participate in this space, and we believe it will provide a lot of value. So -- and we'll get a little bit more information, obviously, as we close that deal and get closer to integrating them into Maravai in the first quarter of 2025. As it relates to the range of potential sensitivities, I think the one thing that throughout the course of the year, frankly, we continue to monitor our sort of the rates of our discovery business. I think there's probably $1 million on each side of that business as far as flexibility there on how those orders come in. Again, that's a long tail of lower volume orders. What we haven't seen this year, both on the RUO and GMP side are these larger drop-ins that we periodically get as companies move from one phase to another or just need, frankly, CleanCap to cover a variety of programs that might be in there and they're stable. Typically, those have been $0.5 million up to $5 million type of drop-in orders, they don't get a lot of visibility to, and they just haven't been occurring. So we're not counting on those prospectively. That having been said, we do have a range of outcomes for some of our GMP builds as we get through that work this year. That's probably another couple of million either way as we go through that. And then the rest of our businesses just have their normal volatility in and around those ranges. But certainly, with the high-volume CleanCap number that Dan mentioned on his question, that is certainly locked in. So we do still have a little bit of variability on the rest of the NAP business. And again, it's just getting back to the fact that we haven't seen those larger POs come in. And so a lot of this is a little bit based on smaller orders, which are just more volatile. And then there's a little bit of work in and around getting things done on the GMP services side, certain revenue recognition, mass specs, et cetera. And then we're going to see a little bit of volatility as we've been seeing throughout the course of the year as it relates to the BST segment as well, even though that's a much tighter range.

Your next question comes from the line of Tejas Savant with Morgan Stanley.

This is Yuko on the call for Tejas. While you know that you'll be providing a formal guidance at a later date, in light of your business being largely skewed towards nondiscretionary cost items, how should we think about guardrails for margin expansion next year?

Well, I'll speak generally. Look, again, we continue to be a company that is predominantly going to go up and down from a margin expansion perspective based on our revenue base. As you look at us today, we have -- as you look at our midpoint and roughly our adjusted EBITDA, we have -- at the midpoint, $260 million revenue company with roughly a $235 million, $240 million cost basis there. And of that cost basis, a big chunk of it, roughly half is labor related. So that's sort of semi-fixed, if you will, [Technical Difficulty] short term, more variable in the long-term. Then the facility costs on top of that are another big component. We operate across about 6, 7 different facilities, and if you count Flanders is 1 or 2 buildings. And that's a big fixed cost for us. The nice thing about that fixed cost is it supports our business model prospectively. We don't need to add any more buildings. We have all the capabilities we need to grow into what we have and expand our margins. And then the last is just the variable piece of our COGS, which is very small. As you know, we have a very high variable margin and sort of everything else, sort of the largest being some of the G&A costs that we need to be a stand-alone public company and some of the legal costs we have as we pursue protecting CleanCap and our IP. So I think from our perspective, it's a matter of filling the factory and leveraging that cost base that I said. I think that I want to say there was a report out earlier in the year that put us in a very nice light as far as revenues per employee. We do not have a big cost base, and we're very efficient at what we do. And to the extent we're able to profitably grow on the top line, that flow-through is going to be very evident as it has been historically. And none of those dynamics have changed.

Yes, I think I'll -- I'll just add that to Kevin's point, the process of stepping into the new capabilities of Flanders 1 and 2 obviously added to our cost base, but we've been bearing those costs largely for the last 4 quarters. And so some of the dynamics we see here on the low and high bounds of each quarter are the reason that we put lumpiness in the comments because, again, the cost base for all of these capabilities is largely fixed and the incremental flow-through on margin is significant as we go above them. The dynamic range, of course, looks extreme as we have a quarter that gets close to that cost basis versus even, say, the prior quarter.

Okay. And then just do you expect any changes to government contracts, including the one with BARDA based on the recent election outcome?

I don't think so. In fact, BARDA was recently here celebrating the opening of Flanders 1 and the pandemic preparedness capacity that comes from that and reiterated that, that's a 10-year arrangement. So I think that should not be subject to any political changes.

Your next question comes from the line of Matt Hewitt with Craig-Hallum Capital Group.

Maybe first one, I was hoping to dig in a little bit on your commentary regarding the soft bioprocessing backdrop. Obviously, there's been some mixed reports so far this earnings season. Some, I guess, more on the consumable side outside of China have commented that, that the market is showing signs of improvement. Others where it's more equipment heavy or more Asia Pacific, China related are still seeing headwinds. What are you seeing? And when you were saying the soft bioprocessing backdrop, I guess, kind of what exactly are you referring to?

Yes, that's an insightful question because I like how you've divided that up. We, of course, look at all of our peers in bioprocessing, both the peers who sell the equipment and peers in CDMO. A significant proportion of the Cygnus customer base is CDMO related. And what we are sensitive to is program starts, specifically and actually heavier weighted on the early side of the funnel. So phase -- preclinical and Phase I, Phase II and so on use proportionately more of the Cygnus host cell protein detection kits than the late Phase II. So as people focus on their downstream or their late-phase projects and deprioritize their early phase projects, it actually has an outsized impact on the number of kits that Cygnus sells. That said, overall, the peer set we look at is -- has centered around flat year-over-year to minus mid- to high single digits. And Cygnus is performing basically in the middle of that range this year with the new guidance. So we think they're essentially at the bioprocessing industry norm. And that's across the whole peer set, whether it be primarily capital equipment-based, consumable-based or the CDMOs.

That's really helpful. And then maybe separately regarding the Officinae Bio acquisition, obviously, software. But I'm just curious, when you look at that, is there some customer overlap? Is what drove you to start those conversations? Was it a customer asking for it? Was this you looking at your portfolio saying, boy, we could really use some help in this area? Just any more color on the why there?

The -- you're exactly right with your former comment or your prior -- your latter, excuse me, comment, which was we needed help. We have the capability from the perspective of input chemistry, the variety of chemistry and now with our new 96-well plate-based mRNA screening product, we have the capability to let people do combinatorial optimization that they've never been able to do before. What we lacked for TriLink was a front-end design environment, one that was informed by bioinformatics and in particular, one that could accelerate and improve the efficacy of designs using AI and machine learning. And Officinae Bio was a start-up that really started there, Software-as-a-Service and a design environment that we're going to bolt right on to the front end that leads to e-commerce that links directly to our LIMS to create not only a seamless design experience for the customer, but a really rapid high throughput experience for mRNA construct experiments and optimization. So it was really primarily driven there. I would say there was no customer overlap. They have a different go-to-market for their DNA and RNA construct services that will be expansionary for us and reach a slightly different target market than we do with our pure-play service business.

Your next question comes from the line of Dan Arias with Stifel.

Trey, in rough terms, what percentage of the gRNA trial starts that you have on that bar chart there are being sponsored by companies that are our customers or do you think have a good chance of being customers? And do you see that activity as needle moving for NAP next year?

I think we do see it as needle moving for NAP. We have reported, as you know, many times, the overall active mRNA program percentage of CleanCap, which, by the way, remains 30%. We haven't disclosed and frankly, it's rather new data for the guide RNA portion of that. So keep in mind, those trials include 2 shots on goal for us. The existing mRNA that would express the Cas endonuclease in vivo and the newer area, which is for GMP guide RNA. I'll pass that to Drew for a few more comments.

Yes, sure. Look, I would say the -- we don't see any sign that the percentage participation of CleanCap is any different. Not all of those programs use mRNA, but I think the participation -- best we can tell is likely the same. We certainly -- anecdotally, we see a lot of activity there, Dan. The participation of mRNA in that universe appears to us to be growing versus other modalities, but we only see what we see. I think percentage-wise, we don't see any difference.

Yes. Okay. And then just a follow-up, Kevin, on the EBITDA guidance, how derisked do you think the 4Q outlook there is? And then performance has been pretty tied to the hip with revenues, which you've talked about. Do you think as you come off of some of these things that are going on in 2024, that can maybe decouple a bit? Do you see yourself having some additional flexibility that just sort of gives you some wiggle room if the top line doesn't materialize the way that you forecast? Or is the P&L relationship pretty much what it is to Trey's point, there is a lot of fixed cost there?

Yes. I think following our restructuring in the fourth quarter of last year, I think we've got the cost structure to a place that we find is appropriate. It's lean. It allows us to best care for our customers and do what we want to do while not only staying lean, but also continuing to make some incremental investments in commercial. I think that continues to be the one area that we never really came out of the box very strong in most of our acquisitions. And as we formed this company, it's been very science-based, very operational, and I think in a much more competitive landscape today. And I think having those feet on the street and getting customer intimacy will continue to be important. So we're going to continue to invest there as we have been over the last couple of years. I don't see the business model changing such that we'll have more discretionary spend to offset changes in revenue. I think the model is a good one, frankly. It's about filling up the factory and driving the top line. And I think that's going to be our continued focus here for the fourth quarter and as we move into 2025.

Okay. Well, everyone, it appears we're having some technical difficulties. I apologize to anyone still in the queue. We will try to follow up with you individually. Thank you for your time. Again, apologies for this technical issue, and we hope we can connect with you. We'll be at a couple of conferences during the month of November and hope to see you there.