Maravai LifeSciences Holdings Inc (MRVI) 2025 Q4 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

  • Hello, and welcome everyone joining today's Maravai LifeSciences Q4 2025 results earnings call.

  • (Operator Instructions) Please note this call is being recorded.

  • We are standing by if you should need any assistance. It is now my pleasure to turn the meeting over to Deb Hart. Please go ahead.

  • Deb Hart - Head of Investor Relations

  • Good afternoon, everyone. Thanks for joining us on our fourth quarter and year in 2025 earnings call. The press release and slides accompanying today's call are posted on our website and available at investors.maravai.com.

  • As you can see from the agenda on slide 2, our CEO Bernd Brust will provide a business update, and our CFO, Raj Asarpota will review our financial results. Dr. Chanfeng Zhao, our Chief Scientific Officer, will join us for our Q&A session.

  • Turning to slide 3, I'd like to note that we have renamed our two reportable segments from nucleic acid production and biologic safety testing to TriLink and Cygnus, respectively. This change is to better align with our brands and internal operating terminology.

  • There have been no changes to the composition of our reportable segments, the nature of the products and services offered, or the manner in which we evaluate the company's operating performance or allocate resources. This change is nomenclature only and does not impact our segment composition, financial results, or historical comparability.

  • Throughout today's call, we will be referring to our two segments by this updated terminology.

  • 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 expectations. We refer you to slide 4 for details on forward-looking statements and our use of non-GAAP financial measures.

  • The press release provides reconciliation to the most directly comparable GAAP measures, and we also post reconciling schedules to our investor website. 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 Bernd.

  • Bernd Brust - Chief Executive Officer, Director

  • Good afternoon, and thank you for joining us.

  • After assuming the CEO role last June and implementing the restructuring actions we announced last August, the management team and I were clear on our priorities. Simplify the business, improve operational execution, increase customer interaction, and deliver better financial results. We are doing exactly that.

  • Let's turn to our financial results on slide 5. Today we reported full year revenue of $185.7 million, exceeding guidance by about $700,000. Total Q4 revenue was $49.9 million, excluding the $14.3 million comparison from high volume CleanCap sales in Q4 2024, revenue grew 18%.

  • Growth was driven by strong performance in GMP consumables and CDMO services at TriLink. And by core customer demand for host cell protein kits at Cygnus, with all of our top five customers increasing their HCP kit purchases during the quarter.

  • Raj will walk through the full year and fourth quarter results in more detail. But I would like to highlight a key milestone this quarter.

  • We demonstrated the leverage of our new operating model by delivering positive adjusted EBITDA of just over $500,000 in Q4. This represents an improvement of approximately $11 million sequentially from Q3. This marks the company's first return to positive adjusted EBITDA in four quarters.

  • We achieved this well ahead of our internal expectations. The improvement was driven by disciplined execution across the organization, including exceeding the $50 million in cost saving targets we set as part of the restructuring, coupled with stronger revenue and more favorable product mix.

  • I want to thank our entire team for their efforts over the second half of 2025. Because of their work, we believe the company is now positioned to return to full-year revenue growth, deliver positive adjusted EBITDA, and positive cash flow in 2026.

  • Let me briefly highlight what we are doing differently and how our operational changes are delivering improved results.

  • First, our commercial execution. We have materially increased our direct engagement with customers at TriLink, positioning CleanCap as the product of choice and as part of a broader portfolio that includes our enzymes, oligos, and our newly released ModTail product.

  • This reflects our strategy to expand TriLink beyond capping reagents and deepen our role across the full mRNA and gene-based therapeutic workflow from early discovery through clinical development and into commercialization.

  • By engaging earlier and across more components of the workflow, we increase our opportunity per program and strengthen our position as a long-term strategic supplier. A good example is our upcoming launch of GMP enzymes next quarter.

  • Based on the commercial team's improved customer engagement, we are already seeing strong demand, with more than $1.2 million of GMP enzymes orders in hand for 2026. This illustrates the model. We support customers in discovery with research grade consumables and services, and as their programs advance into clinical trials, we are positioned to transition with them to GMP grade supply.

  • In discovery, mRNA Builder is enabling earlier, higher value engagement with our research customers. mRNA Builder is TriLink’s AI and computer-aided design and ordering platform that simplifies designing optimized mRNA. Customers upload their gene of interest, and the platform guides them through the design of a high performance mRNA construct.

  • This platform is increasingly becoming embedded in customer workflows, as evidenced by direct customer feedback and repeat usage. And as these discovery programs advance, this naturally supports pull-through of our GMP portfolio. Few competitors can offer this continuity from discovery through commercialization, and that continuity is a meaningful differentiator for us.

  • Operationally, we have reduced fixed costs, centralized operations, and made the business far less sensitive to volume fluctuations. We now have clear ownership and accountability, removed functional silos, and improved the speed of decision making.

  • We have implemented additional automation to improve efficiency and consistency across the organization, and our new automated EU site allows us to quickly supply screening for the European market. These are structural, sustainable, and scalable improvements, combined with our technical rigor, regulatory credibility, and reputation for high-quality supply. These changes further reinforce TriLink’s position as a partner of choice.

  • From an R&D perspective, we are prioritizing investments in the highest return opportunities across mRNA, cell and gene therapy, and the biologic safety testing business. Products introduced in the second half of 2025 are already showing strong traction, and our development roadmap is focused on areas where we can most clearly differentiate our capabilities and best serve our customers' needs.

  • We have a robust pipeline of NPIs planned for 2026. Our recently launched ModTail technology continues to see strong early adoption, generating over a half million dollars in 2025, an unusually strong start for a newly introduced consumable in our market. We have already surpassed that level in 2026 year-to-date bookings, with engagement across several large pharma companies.

  • Importantly, early customer data and our own internal studies demonstrate improved protein expression and extended duration of expression, both critical attributes for the next-generation RNA therapeutics.

  • We're also investing in additional capabilities at Cygnus. During the quarter, we expanded our mass spec infrastructure to increase capacity and broaden our analytical service offerings. This positions us to offer services that provide drug developers with a full understanding of the host cell protein in drug substances, ultimately leading to increased patient safety and product stability.

  • We view analytical services as a strategic growth lever for Cygnus, complementing our existing HCP and ELISA kit business. We also continue to invest in our MockV product line for viral clearance prediction, as we see quarter on quarter, year on year growth driven by increased market penetration and encouraging regulatory feedback.

  • Taken together, our commercial execution, operational discipline, and focused R&D enable faster decision making, improved responsiveness, and altogether a strong foundation for long-term durable growth and profitability.

  • In addition to our improved internal execution, let me share some of what frames my optimism for 2026 on slide 8. The broader tools and biotech environment appear to be stabilizing. Biopharma funding is showing signs of recovery, particularly in the private markets. Large pharma remains active, and well-funded biotechs are advancing programs, while smaller players remain cautious. While academic and government funding remains muted, we have low exposure to those markets. Overall, we're seeing strong order volume and increased visibility.

  • We are also seeing continued expansion in the number of companies pursuing mRNA and guide RNA programs globally, which according to the Beacon RNA database is now 809 companies compared to 643 a year ago. That growth reflects sustained scientific and commercial interest in RNA-based approaches.

  • As delivery technologies advance and pipelines broaden, both emerging biotech and established biopharma continue to invest in RNA platforms.

  • At the same time, companies continue to prioritize capital and rationalize early-stage programs. Importantly, this has not resulted in a meaningful decline in overall clinical trial activity. Trial activity by phase remains stable, and we continue to see solid engagement across discovery, pre-clinical, and clinical development.

  • TriLink currently works with about 250 to 300 companies on a regular basis, or roughly one-third of the companies pursuing mRNA and guide RNA programs. We believe with our newly released ModTail technology, we have an opportunity to penetrate additional customers and programs regardless of capping methods.

  • Finally, customer feedback suggests the FDA remains constructive in areas such as cell and gene therapy, particularly in rare disease and oncology, where expedited pathways continue to be utilized. While infectious disease vaccine development may face a more measured approach in the current US environment, our exposure to the vaccines is low, and therapeutic programs continue to progress.

  • What I'd like to leave you with is how confident I am that the fundamentals of this business are solid. We have leading technologies, we have long-standing customer relationships where we continue to build greater transparency and intimacy.

  • We have deep scientific credibility. Now all that coupled with the right team and appropriate sized operations to execute.

  • Now I'll turn the call over to Raj for more details on the quarter and year-end results and our 2026 financial guidance.

  • Rajesh Asarpota - Chief Financial Officer

  • Thank you, Bernd. Let's turn to the Q4 financial results on slide 10. Revenue for the quarter was $49.9 million compared to $56.6 million in Q4 2024, as Bernd noted, excluding $14.3 million of high volume COVID GMP CleanCap sales in the prior year quarter, revenue increased 18% year over year.

  • As Deb mentioned at the start of the call, we have renamed our two reportable segments from nucleic acid production and biologics safety testing to TriLink and Cygnus, respectively.

  • TriLink generated $34.6 million of revenue, down 17% year over year. Excluding the $14.3 million COVID CleanCap comp in Q4 2024, TriLink base revenue grew 25% year over year, driven by GMP consumables and CDMO services.

  • Cygnus revenue was $15.3 million, up 4% versus last year. I'll discuss segment results and profitability a little later in the call.

  • Revenues by customer type in Q4 were 31% biopharma, 29% life sciences and diagnostics, 4% academia, 11% CRO, CMO, CDMO, and 25% distributors. Revenue by geography in Q4 was 55% North America, 15% EMEA, 21% Asia-Pacific, excluding China, 8% in China, and 1% Latin and Central America.

  • Turning to slide 11, our GAAP net loss before non-controlling interest was $63 million for the fourth quarter of 2025. This included a $25.8 million non-cash intangible asset impairment charge related to TriLink, and $12.1 million of non-cash restructuring charges, including lease and bind costs. This compares to a GAAP net loss before non-controlling interest of $46.1 million in Q4 2024. For the full year, GAAP net loss was $230.8 million compared to a loss of $259.6 million for 2024.

  • Adjusted EBITDA, a non-GAAP measure, was positive 536,000 for Q4, above our expectations, driven by efficiency of initiating our cost restructuring actions and stronger revenue. This compares to $1.1 million in Q4 2024. For the full year, adjusted EBITDA was $31.2 million versus $35.9 million for 2024.

  • Moving to slide 12 and EPS. Basic and diluted loss per share in Q4 was $0.24 compared to a loss of $0.18 per share in Q4 2024. Adjusted EPS was a loss of $0.04 compared to a loss of $0.06 last year. For the year, basic and diluted loss per share was $0.90 versus the loss of [$1.05] in 2024. Adjusted, fully diluted EPS, a non-GAAP measure, was a loss of $0.29 per share versus a loss of $0.10 in the prior year.

  • Advancing to the balance sheet, cash flow, and other financial metrics on slide 13. We ended the year with $216.9 million in cash and $294.2 million in long-term debt. Cash used in operations in Q4 was $22.8 million, including $3.6 million related to restructuring. Depreciation and amortization was $12.4 million. Net interest expense was 4.2 million.

  • Stock-based compensation, a non-cash charge, was $3.9 million for the quarter. During Q1 2026, we made a voluntary $50 million debt repayment using cash on hand. As a result, both cash and total debt were reduced by $50 million from these year-end numbers. We believe this was a prudent step to reduce ongoing interest expense.

  • Next to slide 14 and the discussion of segment performance. TriLink revenue was $34.6 million in Q4, representing 69% of total revenue. Excluding the $14.3 million COVID CleanCap comp in the prior year quarter, base revenue grew 25%, driven by GMP consumables and CDMO services.

  • TriLink generated $936,000 of adjusted EBITDA in Q4, returning to positive adjusted EBITDA for the first time since Q4 2024. For the full year, TriLink revenue was $119.8 million, or 64% of total revenue, with adjusted EBITDA of $23.1 million. Excluding high volume CleanCap revenue, TriLink revenue declined 8% for the year.

  • Cygnus revenue was $15.3 million in Q4, up 4% year over year, and representing 31% of total revenue. Growth was driven by continued demand for HCP kits, particularly from our core customers. Cygnus delivered $10.2 million of adjusted EBITDA in Q4 for a 66.7% margin. For the full year, Cygnus revenue increased 5% to $66 million, with adjusted EBITDA $44.2 million and a 67% margin.

  • Corporate shared services expense impacting adjusted EBITDA was $10.6 million in Q4, down $2.8 million sequentially. These expenses include HR, finance, legal, IT, and public company costs.

  • Please turn to slide 15. As Bernd mentioned, we are ahead of our previously announced target of greater than $50 million annualized reduction in expenses and are now estimating savings of greater than $65 million. We continue to identify additional opportunities to streamline operations and improve profitability.

  • Now let's discuss our financial expectations for 2026 on slide 16. We expect total revenue of $200 million to $210 million, representing growth of 8% to 13% over 2025. We expect TriLink to grow low double-digits at the midpoint, driven by double-digit growth in GMP consumables and stabilization in discovery. Cygnus is expected to grow low to mid-single-digits year over year.

  • We expect full year adjusted EBITDA of $18 million to $20 million, representing an improvement of $50 million to $52 million over 2025, primarily from improvements in our TriLink segment. We expect gross margin expansion of approximately 1,200 basis points year over year, driven by our restructuring actions, cost initiatives, and product mix, as we expect greater revenue contributions from TriLink GMP consumables.

  • Total operating expenses are expected to decline approximately 13%. G&A expenses are expected to decline approximately 18%, and sales and marketing should decline approximately 13%. R&D is expected to be modestly up as we continue to fund new product innovation. To help you with your modeling, here are a few additional expectations behind the guide.

  • Interest expense, net of interest income, $15 million to $17 million. Depreciation and amortization of 50 million to $52 million. Stock-based compensation of $26 million to $28 million. Assumed fully converted share count of approximately 261 million shares, net capital expenditures of $4 million to $6 million.

  • Finally, I'd like to provide an update on internal controls and the securities class action litigation. As you'll see when we file our 10-K this week, we have completed the implementation of a remediation plan and enhanced the design and operation of our controls to address the previously identified material weaknesses. Those weaknesses related to controls over our revenue process, as well as controls around key inputs and assumptions used in determining the fair value of our reporting units in the quantitative goodwill impairment assessment.

  • To remediate these matters, we strengthened controls over period-end revenue recognition and pricing approvals, enhanced the review and documentation of key inputs and assumptions used in the goodwill impairment analysis, and provided additional training to control owners.

  • In addition, I'm pleased to report that the United States District Court for the Southern District of California dismissed in full the securities class action lawsuits against Maravai and certain of our former executives. I want to thank the team for their focused work in resolving these matters. In closing, our fourth quarter reflects the benefits of the actions we have taken.

  • Sequential revenue growth, positive adjusted EBITDA, and continued cost discipline. We're entering 2026 with a leaner cost structure, improved operating leverage, and clear priorities. We remain focused on execution, driving revenue, and continued margin expansion.

  • I'll now turn the call back to the operator for Q&A.

  • Operator

  • (Operator Instructions) Matt Stanton, Jefferies.

  • Matthew Stanton - Analyst

  • Hey, thanks. Maybe on the commentary on visibility improving and the color on slide 8 you talked about strong order volume. Is it fair to say orders are tracking, kind of ahead of what you're guiding on revenues for '26 on year on year growth? So maybe just, de-risking a bit or leaving a bit of, upside. Is there any more color you can give in terms of order and funnel growth, tied up the strong. Order volume and and if yes you know maybe spike out some of the opportunity where you see the most areas of upside as we move through 26 here.

  • Bernd Brust - Chief Executive Officer, Director

  • Thanks, Matt. That is Bernd. We shared in our last earnings call that, you know, there's a little lumpiness, of course, in this business, right, in the business that's, a couple $100 million in revenue, and our average order volume is fairly high.

  • Average order cycle is about six months, but it's hard to get a true outlook on what happens for the full year. And so we're certainly, I think, trying to be somewhat conservative as to how we set ourselves up for the future here. But specific to your question, order volumes are materially higher, so far, than they were last year at this period of time, so that's a good sign, obviously.

  • Where we see that specifically is in the, TriLink world in our GMP consumables, as well as our larger order sizes in discovery, right? We look at our business in discovery into sort of two categories, orders under average 15,000, where we assume those sales people are involved, and orders over 15, that does require usually some kind of sales involvement. Where we're seeing material growth in this, in these larger orders in discovery alongside the GMP. But order volumes are great, and, we feel very confident about where we are with our forecast for the year.

  • Matthew Stanton - Analyst

  • Thanks. And maybe just on the GMP consumables, you talked about the strength and ’25, the strength in orders. You talk a little bit more about, is that tied to, a few programs moving further through the clinic? Is it selling, more products into the GMP consumable ecosystem? Just talk about maybe some of the underlying demand factors, underpinning the, GMP consumable strength you've seen. Thanks.

  • Bernd Brust - Chief Executive Officer, Director

  • Yeah, it's really a broad set of customers, it's, there's really not one customer that stands out that says this is where we're seeing all of our growth, so I think that's the beauty actually about the business at the moment, where certainly the COVID years, great revenues, but from a very small number of programs. The number of programs is quite significant at the moment, and so, yeah, we feel good about the depth of our customers that we are currently interacting with.

  • Operator

  • Subbu Nambi, Guggenheim.

  • Subbu Nambi - Equity Analyst

  • Hey guys, thank you for taking my question. First one is on the gross margin expansion of 1,200 bps from restructuring, cost initiatives, and product mix. Can you break out each of these buckets if possible?

  • Rajesh Asarpota - Chief Financial Officer

  • Yeah, sure, we can, I can give you the details on the cost savings that we've outlined before. So we talked about the $55 million that we previously mentioned, and now the actual gross margin expansion is going to be coming from the $65 million annualized savings, and again I'd like to remind you that we captured about $3 million of that in Q3, and another $8 million in Q4.

  • So the $65 million in annualized cost savings basically resets the fixed cost base to create that margin lift, on gross margin, which is independent of volume growth, and then there's additional expansion on gross margin that's going to come from mix, mainly from GMP consumables contribution, and the operating leverage as we continue to, expand revenue.

  • Subbu Nambi - Equity Analyst

  • Thank you for that. And then one high level, AI's role in drug discovery, development, and manufacturing is the investor focus of late. How is Maravai using AI, either at the Flanders site and R&D, or otherwise, to generate efficiency? So the question is how is AI driving efficiencies in the business?

  • Bernd Brust - Chief Executive Officer, Director

  • Yeah, I think we're implementing this in various areas of the organization. You heard us talk about mRNA Builder, that we went live with, I think it was the third quarter of last year. It's really an automated platform, that we acquired through the efficient acquisition, early last year, that allows customers, without really any human intervention, to upload their, DNA construct, and then create an optimized RNA construct from there. I think so far, since we've been live, something like 70 or so orders have been going through that system. It's gradually picking up, but that's probably the biggest involvement of AI that we have at the moment. I can't speak to whether we use that in the CDMO world. I don't believe so.

  • Operator

  • Matt Larew, William Blair.

  • Matt Larew - Analyst

  • And congrats on the update. It seems like you've turned a corner here. I wanted to ask about the guide for the year, just given Q3 and Q4, you had some lumpiness with some of the CDMO builds, and so, a number of larger peers have characterized perhaps a softer first quarter, though they're optimistic about the build for the year. So just curious if there's anything you'd call out either from a prior year comp or, an expected order conversion that might affect pacing in the first quarter in particular.

  • Bernd Brust - Chief Executive Officer, Director

  • Well, listen, we're optimistic on Q1, as we shared, we're optimistic on the year, as well, on the top-line. It's really not any serious negative comps. Obviously, we comp out all of the COVID, hits that we had against '24 and '25, but when you look at the orders that we are currently, seeing in the business, it's a real, quite a diverse set of customers across the portfolio of TriLink, and obviously Cygnus continues to run at their mid-single-digit revenue levels as well.

  • So, we really don't look at it as a, as a negative or positive comp in Q1. I think if you look at this year, probably Q3 last year was pretty tough on the, on the GMP world, so we'll see what that means this year on Q3. But certainly, as we look at the first half of the year here, we shared with, I think, the group here, in September, that we were expecting somewhere between $10 million and $20 million worth of COVID CleanCap in 2026, specifically the first half. We still expect that to happen in the first half, so that is the one positive comp that you'll see in the first half. But other than that, I think it's true strength of customer spending.

  • Rajesh Asarpota - Chief Financial Officer

  • I think, the one thing that, again, what we I think we spoke about this in the previous call in terms of our commercial engagement, and how that's giving us better visibility into, the GMP consumables world. So that continues to happen. So on the strength of that, we've seen, Q1 coming in relatively strong, and we, and that's going to kind of continue through the balance of the year.

  • Matt Larew - Analyst

  • Okay, and then, you know, the, cost reduction program came in ahead of schedule, and I think the way you guided OpEx is good to see in terms of R&D getting dollars but finding efficiencies other places. Prior to COVID, Maravai operated with EBITDA margins above 40%, though that was maybe largely a private company, and I understand it's maybe not a perfect comp, but if you think about the midpoint of the guide this year, EBITDA margins being roughly 9%. And where you expect to be in the future, obviously now you have a services portfolio, you've added, you're adding new products, which we don't fully know the margins of, but where do you think margins can go long-term, and understanding that long-term is maybe undefinable in terms of timeline at this point, but just in terms of the structure of the business and the kind of products and services you're offering, what do you think you can get over time?

  • Bernd Brust - Chief Executive Officer, Director

  • I think you're going to get your margins up, truly through higher product sales, right? When you look at the organization today, you have a fairly complex GMP operating model here that, you did God knows how much volume during COVID that sits in the same infrastructure we still have, so we can absorb a large number of, of other GMP orders, without really increasing our cost structure with the exception of raw materials and maybe a little bit of labor. So, the natural margin increases, I think, are going to come purely from revenue growth over the, over the outlying years here.

  • Operator

  • Matt Hewitt, Craig-Hallum.

  • Matthew Hewitt - Analyst

  • Maybe first up, regarding the restructuring, you got through that earlier than expected. So should we anticipate that the, expense lines kind of have reset at this point, maybe a little bit below the Q4 numbers for SG&A and all that, and kind of show some normalized growth, COLA growth, if you will, over the course of the year, or is there still yet one more step down after Q1?

  • Rajesh Asarpota - Chief Financial Officer

  • Okay, so, again, going back at the, going back to the macro level, the $65 million in expense reductions that we've outlined. Those expense categories haven't changed. Some have moved a little bit towards being more favorable, our labor expense profile is going to remain the same. Our facilities is going to essentially remain the same. Our controllables expense are going to be down a lot more than we anticipated. And then just by the account types, if you look at our COGS profile.

  • That's going to materially, essentially remain the same, but on the OpEx side, we're going to get a lot more out of G&A, and like we said, we're going to invest a little bit on R&D, and then sales and marketing is going to essentially remain the same. There will be another modest drop in Q1, though thing is to get to your question directly.

  • Matthew Hewitt - Analyst

  • And then maybe a separate question. The FDA recently, provided a new draft guidance, regarding, some of your markets, and I'm just curious what your thoughts were on that draft guidance, and more importantly, when do you think that you could maybe start to see some benefit from that?

  • Bernd Brust - Chief Executive Officer, Director

  • Yeah, I don't think we have internally looked at that very closely. We don't have a ton of exposure, on where that dialogue sits at the moment, and so I don't think we have a clear point of view on that at this stage.

  • Operator

  • Catherine Schulte, Baird.

  • Unidentified Participant

  • This is Josh on for Catherine. Thanks for taking my question. You mentioned that, you're working with around 250 to 300 customers within the mRNA ecosystem. I was just wondering, where kind of market shares shake out between clinical and pre-clinical customers, and how you kind of characterize the recent market share dynamics there. And then just lastly, how do you kind of feel about current mRNA pipeline trends heading into 2026?

  • Bernd Brust - Chief Executive Officer, Director

  • Yeah, I think we assume about a third market share, right, of mRNA customers out there. It's not always that easy to talk about programs because we don't always know how many programs a customer is running at a given point in time, but I think if you look at our GMP revenues, which Raj, which are this year forecasted, what number do you remember.

  • Rajesh Asarpota - Chief Financial Officer

  • GMP consumables.

  • Bernd Brust - Chief Executive Officer, Director

  • It's somewhere around --

  • Rajesh Asarpota - Chief Financial Officer

  • 45.

  • Bernd Brust - Chief Executive Officer, Director

  • $45 million, right, something like that, and so that, that suggests that your discovery business is still, you know, larger than, than our GMP business, so I would say that today in the GMP world, I know it's a third of our revenue, something like that, and we're seeing the fastest growth happening there, so you know that certainly, to us, indicates that you're going to continue to see more programs coming into the GMP world, or programs progressing and buying higher volumes.

  • Unidentified Participant

  • Great. And then throughout 2025 we saw a lot of policy headwinds around areas like mRNA, cell gene therapy, and MFN. You're heading into 2026. How are you feeling about the broader policy backdrop here, and how does this inform the improved visibility that you're seeing across the business?

  • Bernd Brust - Chief Executive Officer, Director

  • Yeah, I think a lot of the policy has been driven around vaccines, right? And so we really don't have a ton of exposure in that area any longer, now that we've washed through the COVID comps from 2024. But when you look at just customer behavior and, we're a consumables provider, and we're directly dependent, of course, on customers doing either mRNA research or trials.

  • We're starting to see more and more traction coming from our broader customer base, not just in GMP, but also in the discovery world, and that tends to be the best sign, of course, and that you have to assume when you have larger discovery orders coming in, that some of those will move into a GMP clinical trial world at some point. So the fact that, again, discovery orders at larger size are becoming more and more, I think, prominent at the moment is a very good sign where we think the GMP world will lead into.

  • Operator

  • Justin Bowers, Deutsche Bank.

  • Justin Bowers - Analyst

  • So, speaking with GMP, can you give us a sense of, what that, how much revenue that generated in 2025? And then, as we think about 2026, excluding, the COVID revenue, is there any seasonality that we should take into consideration for TriLink?

  • Bernd Brust - Chief Executive Officer, Director

  • I don't think there's seasonality necessarily. That's the interesting part about this business. The lumpiness exists, based on these order sizes, and really until you get some of these programs becoming commercial, you have changes from certainly discovery into GMP. You have certainly movement from phase 1 to 2 to 3.

  • Some programs don't make it out of certain trial levels, and so the lumpiness that we see in the business is really not seasonal. It's purely tied to really how successful these clinical trials are. But yeah, the nature of our business is such that, because these orders are fairly large, as they shift between programs, they will likely shift between time as well.

  • Justin Bowers - Analyst

  • Understood. And just a quick follow-up, what was GMP consumables in, in 2025? And then, part two of that would be, I think, last year you talked about maybe some, maybe sharing space, or thinking about some alternative revenue generation, activities in Flanders, and just curious if there's an update on those issues.

  • Bernd Brust - Chief Executive Officer, Director

  • Well, on the facility front, that we have, one of our Flanders sites is our CDMO business, and that's fully occupied, by that, and the other Flanders site, currently we don't occupy, we have, closed that facility. If we find somebody to take it over, we will deal with that at that point, but we're not looking for incremental revenues necessarily coming from that piece. And so that has been all addressed, I think, in our accounting world as well. We don't take those in, into our EBITDA lines any longer. On the question around GMP consumables, maybe Raj, you have those numbers.

  • Rajesh Asarpota - Chief Financial Officer

  • Yeah, we don't break that out completely, but if you look at the GMP and CDMO business combined, that's in the mid-thirties last year.

  • Bernd Brust - Chief Executive Officer, Director

  • And by the way, I'm sorry for the just for clarification, the $45 million I mentioned a minute ago for GMP consumables, that excludes CDMO.

  • Operator

  • Doug Schenkel, Wolfe Research.

  • Doug Schenkel - Equity Analyst

  • The first on APAC, the second on MockV. So, starting on APAC as a percentage of revenue, APAC increased, pretty meaningfully in the fourth quarter compared to the 3rd quarter. I think you said China was stable. So it does seem to imply that there was a pretty big pickup in Asia ex China. Am I thinking about that right? And if so, what drove that change? And is this a trend that you expect to continue into 2026?

  • And then on MockV, you called out demand as a driver of growth in the quarter. How has that been trending, and how do you expect that to contribute in 2026? And I'm just wondering if, over time, that could be a contributor to driving overall Cygnus growth up above the mid-single-digit construct. Thank you.

  • Rajesh Asarpota - Chief Financial Officer

  • I'll take the -- I'll start with the APAC and, it -- like, in Asia Pacific in Q4 was driven by two large GMP orders, but they were kind of tied to our ongoing programs and partnerships, and not kind of the one-time events, and then, so, you know, we view this as a sustainable, kind of event, and reflective of the ongoing improving program momentum we have, and it's not a one-off event. So that was what drove the APAC growth, and then, what's your second question again, sorry.

  • Yeah, we did see MockV growth, and we think that product has shown tremendous kind of runway from last year to this year, and in 20 from '24 to '25, and we see continued kind of growth on, on that product line within Cygnus for 20.

  • Chanfeng Zhao - Chief Scientific Officer

  • If I also may add MockV, so Cygnus has supported several customers with their, including MockV data in customers' clinical trial application. So, the initial approach has been positively received by, regulatory agencies. So the idea of MockV could potentially replace expensive, lengthy viral clearance study, which can really broaden our potential customer base.

  • Bernd Brust - Chief Executive Officer, Director

  • We think MockV has great potential runway here, and I think it's a good indication of that. I'll also say, don't expect that to happen in three months. I think it's a longer cycle business, and the short-term growth. I think the question was, how do we potentially look at Cygnus growing faster than mid single-digits.

  • I think certainly, long-term, MockV could be a player there. We've invested some for services. We brought another mass spec into the organization, so I think you'll see some opportunity coming from there, and I think you're right, Asia does have some opportunities that are potentially there for us to capitalize on.

  • Thank you, again.

  • Operator

  • Matthew Parisi, KeyBanc Capital Markets

  • Matthew Parisi - Analyst

  • Matthew Parisi on for Paul Knight at KeyBanc Capital Markets. Congrats on the great quarter.

  • So, quick question about the COVID CleanCap revenue. You've mentioned that $10million to $20 million will come in, the first half. Can we assume that there'll be additional COVID, CleanCap revenue in the second half?

  • Bernd Brust - Chief Executive Officer, Director

  • No, I think we shared with all of you in Q4 that we expect $10million to $20 million will be the total number for 2026, so we kind of look at that as the ongoing run rate, in the following years as well, and you should keep that number in as a guidance for the business. We expect this year that all to come into the first half of the year.

  • Matthew Parisi - Analyst

  • And then next would be, kind of, you talked to the significant traction you're seeing in ModTail. I was wondering if you could talk to the traction you're seeing in the new IVT kits, and then, you previously mentioned that you intend to launch new kits in 2026, and when could we potentially expect to see the launch of those kits?

  • Bernd Brust - Chief Executive Officer, Director

  • Chanfeng, you want to answer that, or would you like me to.

  • Chanfeng Zhao - Chief Scientific Officer

  • Yeah, so we've -- the ModTail, we launched the mRNA service and the catalog mRNA, and so that the data coming back from customers, that they're very positive, and so they are starting asking, as Bernd mentioned, that we have large pharma companies using this technology, and as the positive data coming back, they are asking, sort of, IP related question, obviously we'll be ready for GMP to meet the customer demand. And for the, the IVT kit, as TriLink has been doing mRNA for many years, so we have, deep knowledge in IVT, CleanCap, so, so. The kit is really well received in the field. We have over 100 kits ordered first few weeks, first four weeks, and we see sequential growth from Q3 to Q4, and we also see, more adoption in the field. We also converted one major customer, from competitor to use our kit.

  • So it's all good, and, we are going to launch more kits, and in different version of kits, to meet customer demand this year.

  • Bernd Brust - Chief Executive Officer, Director

  • The ModTail is an interesting product. I mean, it's still early days, obviously, but the fact that we officially launched this in September, through a commercial organization, well over a million dollars in orders already, and that's through, Chanfeng’s comments, service, and some catalog mRNA, feedback that's come back from customers, have been quite impressive, and so we.

  • We have a lot of confidence of this product becoming a big driver of revenue growth for our business in the years to come.

  • Operator

  • Thank you. Thank you. At this time, there are no further questions in queue. I will now turn the meeting back to our presenters for any additional or closing remarks.

  • Bernd Brust - Chief Executive Officer, Director

  • Thank you. Thanks again, everybody, for dialing in, sticking with us. We know that, we're still new in this organization. I think we are bringing it around very quickly. We are highly confident about the progress that we're making.

  • At TriLink, certainly, that's been stabilizing and positioned for growth in 2026. The fact that Cygnus now has hit its, positive growth quarter three in a row is a great story, and we are confident that's going to have a great 2026 as well.

  • Our cost savings, materially higher than we had initially planned, really without impacting the business, I think, is an incredible sign for the organization.

  • We're going to see EBITDA growth. We're going to see cash positive direction in 2026 again. We're leaner, we move faster, great interaction with our customers, and, highly confident that we're going to have a great 2026 here. So thanks again for your time and interest in the company, and, we'll speak to you again in about a quarter. Thanks.

  • Operator

  • Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.